115: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy Agresti - Part 1

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

#Science #Biology #Cell Culture Technology Innovation Aficionado #David Brühlmann: Biotech Entrepreneur #Bioprocess #Biotech #Cell Culture #Development #CMC #Manufacturing #Scale #Technology #Scientists #Innovation

26:28

Squid Game is back—and this time, the knives are out. In the thrilling Season 3 premiere, Player 456 is spiraling and a brutal round of hide-and-seek forces players to kill or be killed. Hosts Phil Yu and Kiera Please break down Gi-hun’s descent into vengeance, Guard 011’s daring betrayal of the Game, and the shocking moment players are forced to choose between murdering their friends… or dying. Then, Carlos Juico and Gavin Ruta from the Jumpers Jump podcast join us to unpack their wild theories for the season. Plus, Phil and Kiera face off in a high-stakes round of “Hot Sweet Potato.” SPOILER ALERT! Make sure you watch Squid Game Season 3 Episode 1 before listening on. Play one last time. IG - @SquidGameNetflix X (f.k.a. Twitter) - @SquidGame Check out more from Phil Yu @angryasianman , Kiera Please @kieraplease and the Jumpers Jump podcast Listen to more from Netflix Podcasts . Squid Game: The Official Podcast is produced by Netflix and The Mash-Up Americans.…

about a year ago 19:49

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Bioprocess development is transforming the biotech industry, driving innovations in life-changing therapies. Success hinges on simplifying complex mechanisms and adopting advanced technologies. By integrating high-throughput screening and artificial intelligence, we can streamline workflows, reduce trial-and-error, and speed up biologics development. Embracing cutting-edge tools empowers scientists to maximize biology's potential, delivering efficient and impactful biotech solutions.

In this episode of The Smart Biotech Scientist Podcast, host David Brühlmann explores these transformative methodologies with Jeremy Agresti, CTO and founder of Triplebar.

Jeremy highlights the future of bioprocessing at the intersection of high-throughput screening, miniaturization, and AI. With tools that enhance predictability, scalability, and efficiency, Triplebar is set to transform biotechnology. By reimagining traditional methods, improving inputs, and leveraging modern technology, companies like Triplebar are driving a new era in bioprocessing, offering innovative solutions to complex biological challenges.

Key Takeaways:

Jeremy challenges the traditional view of scale-up issues, emphasizing that many problems can be solved at a smaller scale with better engineered strains and cell lines.

By creating tiny bioreactors of droplets, Triplebar is able to perform high throughput screening, testing millions of mutations quickly and efficiently, and providing robust solutions for complex biological functions.

The integration of massive data sets with AI allows for improved enzyme and protein design, unlocking the potential to innovate even when foundational understanding is limited.

Ready to dive deeper? Join the journey of transforming bioprocess development with smart insights and pioneering spirit. Catch up with Jeremy’s full story via the latest episode of the Smart Biotech Scientist podcast.

Connect with Jeremy Agresti:

LinkedIn: www.linkedin.com/in/jeremy-agresti-88546850/

Triplebar: www.triplebar.com

Next Steps:

Overwhelmed by complex bioprocess development decisions? Get strategic guidance to avoid costly mistakes and stay ahead: https://bruehlmann-consulting.com

Are soaring manufacturing costs keeping your lifesaving therapies out of reach for patients? Book your free assessment at: https://bruehlmann-consulting.com/assessment

Support the show

173 episodes

115: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy Agresti - Part 1

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

published about a year ago

MP3•Episode home

In this episode of The Smart Biotech Scientist Podcast, host David Brühlmann explores these transformative methodologies with Jeremy Agresti, CTO and founder of Triplebar.

Key Takeaways:

Jeremy challenges the traditional view of scale-up issues, emphasizing that many problems can be solved at a smaller scale with better engineered strains and cell lines.

The integration of massive data sets with AI allows for improved enzyme and protein design, unlocking the potential to innovate even when foundational understanding is limited.

Connect with Jeremy Agresti:

LinkedIn: www.linkedin.com/in/jeremy-agresti-88546850/

Triplebar: www.triplebar.com

Next Steps:

Overwhelmed by complex bioprocess development decisions? Get strategic guidance to avoid costly mistakes and stay ahead: https://bruehlmann-consulting.com

Are soaring manufacturing costs keeping your lifesaving therapies out of reach for patients? Book your free assessment at: https://bruehlmann-consulting.com/assessment

Support the show

173 episodes

All episodes

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
172: Reimagining Chromatography for Advanced Therapies: From Diffusion to Convection with Scott Wheelwright - Part 2 19:43

1 day ago19:43

19:43

Downstream processing remains one of the most complex and critical steps in biomanufacturing, especially as new therapeutic modalities like cell and gene therapies push current technologies to their limits. The industry faces ongoing pressure to innovate, reduce costs, and improve efficiency, while still ensuring robust and reliable results. In this practical, energetic episode, host David Brühlmann welcomes Scott Wheelwright, Chairman, CTO and Co-Founder of BioChromatographix International (BCI). With a career spanning continents - Asia, Europe, and North America - Scott's perspective is forged from hands-on manufacturing, technology transfer, and building high-growth companies from scratch. He’s not just innovating the science behind chromatography; he’s lived the manufacturing realities, spanning everything from precision antibodies to complex gene therapies, and now leads a team solving the tough purification puzzles holding progress back. Here are three reasons why this episode is a must-listen: Continuous Innovation in Chromatography: Despite a hundred-year legacy, chromatography still holds tremendous untapped potential, especially with new materials and continuous processing, as Scott highlighted with real examples from gene and cell therapy applications. Bridging Lab to Market Needs Customer Focus: Getting new technology into commercial use requires not just technical innovation, but deep user engagement, robust feedback loops, and iterative improvement, plus ongoing education to help users understand new benefits. Embrace Experimentation and Global Collaboration: Whether building companies in Asia, Europe, or the U.S., Scott reminds us that learning from failure, being open to international collaboration, and not being afraid to try new things are essential for long-term growth (and enjoying the biotech journey along the way!). If you’re passionate about downstream processing, tech innovation, or just want to hear inspiring leadership lessons, check out the full episode and connect with Scott Wheelwright or visit the company’s website to follow his team’s advancements. Connect with Scott Wheelwright: LinkedIn: www.linkedin.com/in/scottmwheelwright Website: www.biochromatographix.com Curious about chromatography? Tune in to hear what our previous guests had to say! Episodes 119-120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian Guo Episodes 61-62: Magnetic Bead Technology: The New Era in Downstream Processing with Nils Brechmann Episodes 37-38: How to Master Downstream: A Deep Dive Into Bioprocessing Purification with Wei Zhang Next step: Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
171: Reimagining Chromatography for Advanced Therapies: From Diffusion to Convection with Scott Wheelwright - Part 1 20:35

3 days ago20:35

20:35

For decades, chromatographic purification has made use of bead-based diffusion - a reliable but limiting approach, especially as new modalities like gene therapies, mRNA, and viruses push the boundaries of what’s possible. But what if the future of downstream processing lies not in incremental improvement, but in a dramatic reimagining - from slow diffusion to rapid convection? In this episode, David Brühlmann meets Scott Wheelwright, Chairman, CTO and Co-Founder of BioChromatographix International (BCI). Scott brings decades of expertise in biopharmaceutical development and manufacturing. Prior to BCI, he co-founded Biolnno Bioscience, a leading CDMO, and co-founded Innovent Biologics, one of China’s foremost biotechnology companies. Here are three compelling reasons to tune into this episode: Breaking the Mold of Purification: BCI’s AXISFLOW™ Platform moves beyond bead-based processes, using advanced 3D-printed monoliths that enable convective flow, making purification of large biomolecules and viruses faster, more efficient, and better suited for next-generation therapies. Innovation Starts with Imagination (and Measurement): True progress in bioprocessing often hinges not on what we can make, but on what we can accurately measure and imagine. Scott reminds us that advances in analytical testing and creative thinking are the real engines of change. Biotech Demands More than Great Science: Success isn’t just about inventing; it’s about building with the end-user in mind. Scott’s journey highlights the critical role of customer-centric product development, cross-disciplinary teamwork, and regulatory strategy - especially in a conservative, risk-averse industry. Curious how shifting from diffusion to convection could reshape your purification workflow? Listen to this episode and discover how to unlock efficiency, cut costs, and deliver therapies that might otherwise remain out of reach. Connect with Scott Wheelwright: LinkedIn: www.linkedin.com/in/scottmwheelwright Website: www.biochromatographix.com Curious about chromatography? Tune in to hear what our previous guests had to say! Episodes 119-120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian Guo Episodes 61-62: Magnetic Bead Technology: The New Era in Downstream Processing with Nils Brechmann Episodes 37-38: How to Master Downstream: A Deep Dive Into Bioprocessing Purification with Wei Zhang Next step: Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
170: Why Your DNA Is a Terrible Disease Predictor (And How Multi-Omics Changes Everything) with Mo Jain - Part 2 22:40

8 days ago22:40

22:40

For years, disease diagnosis and treatment have focused on a few biomarkers, overlooking thousands of vital biological signals. Despite biotech advances, most therapies are still based on limited data, missing countless breakthroughs. Multiomics changes that. By analyzing tens of thousands of proteins, metabolites, and lipids, it reveals hidden insights, paving the way for smarter, faster, and more effective medical discoveries. In this must-listen episode, David Brühlmann welcomes Mo Jain, founder and CSO of Sapient, a pioneering force in bringing multiomic platforms out of academia and into the heart of drug development. A physician-scientist by training and a visionary entrepreneur by choice, Mo’s journey spans decades at the cutting edge of analytical technologies, culminating in the creation of ultra-high-throughput systems that analyze up to 20,000 biomarkers in a single run for real-world impact. Here are three reasons why this episode needs to be on your playlist: Multiomics at Scale: Mo shares how his team at Sapient turbocharged mass spectrometry, enabling simultaneous measurement of thousands of molecules, transforming routine diagnostics and making previously unimaginable insights accessible to scientists everywhere. Turning Data into Action: Generating vast data is only half the battle. Mo explains how Sapient developed advanced biocomputational teams and frameworks to extract actionable answers, guiding drug developers to faster, smarter decisions and helping avoid the pitfalls that cripple so many omics projects. The Future Is Personalized and Sooner Than You Think: From dramatically earlier disease detection to truly personalized therapies, Mo paints an optimistic picture of a coming era where AI, multiomics, and new therapeutic modalities rapidly accelerate both discovery and delivery, reshaping how biotech companies tackle even the toughest diseases. Ready to break out of the 20-biomarker rut and see what 20,000 data points can reveal? Tune in to discover how you can harness multiomics in your own research and hear Mo’s advice for scientists and entrepreneurs venturing beyond the bench. Connect with Mo Jain: LinkedIn: www.linkedin.com/in/mo-jain-md-phd-373895ba Website: www.sapient.bio Company LinkedIn Page: https://www.linkedin.com/company/sapientbio Next step: Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
169: Why Your DNA Is a Terrible Disease Predictor (And How Multi-Omics Changes Everything) with Mo Jain - Part 1 25:33

10 days ago25:33

25:33

What if the secret to truly personalized precision medicine lies not in your genetic code, but in your zip code? For years, biotech has focused on genomics to explain disease and drug response, but DNA only accounts for a fraction of the story. The real breakthrough? Multi-omics: the large-scale analysis of proteins, metabolites, and lipids, powered by advanced mass spectrometry and AI, offering a fuller picture of human health. In this episode, David Brühlmann meets Mo Jain, founder and CSO of Sapient, a leader in multi-omics analytics. With over two decades of experience across physiology, biomedicine, and computational biology, Mo has been at the forefront of developing scalable multi-omics technologies that are changing the way we predict, diagnose, and treat disease. From leading an academic lab to building a pioneering biotech company, Mo’s journey reflects a passion for uncovering the hidden 80–90% of disease risk that lies beyond our genes. Here are three reasons you’ll want to listen to this episode: Your Environment Matters More Than Your Genes: Mo explains why your zip code is a stronger predictor of your health than your genetic code, challenging the industry’s long-held beliefs and opening new avenues for disease prevention and risk assessment. Multi-omics Disrupts Drug Development: Discover how integrating thousands of biological data points can revolutionize drug discovery by identifying novel targets, better predicting drug response, and accelerating therapeutic breakthroughs that were previously out of reach. Big Data Finally Becomes Actionable: Thanks to rapid advances in mass spectrometry and computational power, scientists can now make sense of overwhelming volumes of multi-omic data, turning what was once information overload into actionable insights for diagnostics and drug development. Ready to think beyond your genes? The biotech revolution is here, and it starts in your neighborhood. Connect with Mo Jain: LinkedIn: www.linkedin.com/in/mo-jain-md-phd-373895ba Website: www.sapient.bio Company LinkedIn Page: https://www.linkedin.com/company/sapientbio Next step: Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
168: How Generative AI Is Revolutionizing Biotech Regulatory Compliance with Abhijeet Satwekar - Part 2 24:51

15 days ago24:51

24:51

The promise of generative AI in pharma and biotech is huge, but it's also fraught with complexity, especially when it comes to integrating these systems into highly regulated environments. From monitoring evolving guidelines to balancing operational efficiency and data integrity, the journey from hype to real-world impact is filled with both opportunity and skepticism. In this episode, David Brühlmann sits down with Abhijeet Satwekar, Innovation Manager at Merck Healthcare’s Global Analytical Development. Abhijeet has spent years on the front lines of digital transformation in the biotech sector, and his current mission: implementing generative AI for regulatory guideline monitoring, without giving the quality team a collective heart attack. He offers a no-nonsense roadmap for biotech leaders looking to streamline compliance, harness AI potential, and future-proof their operations. Here are three reasons you should hit play on this episode: From Proof of Concept to Real-World Implementation: Discover how Abhijeet’s team moved beyond early excitement to tackle regulatory, IT, and data privacy requirements, carving a safe and compliant path for bringing generative AI tools into GxP and GMP-adjacent workflows. Human-in-the-Loop Isn’t Optional: Learn why user training, prompt engineering, and close collaboration between scientists and AI are essential for extracting meaningful (and accurate) insights, especially in environments where routine and regulation reign supreme. ROI and Regulation - The Balancing Act: Hear candid perspectives on measuring the return on investment for new digital tools, addressing skeptics closer to manufacturing, and why the real game-changer might just be a community-driven, industry-wide approach to regulatory acceptance. Wondering how to unlock GenAI’s full potential - or just avoid the common pitfalls? Dive into this episode for practical strategies, cautionary tales, and actionable insights from someone who’s actually navigated the compliance minefield. Bring AI into your pipeline with confidence, clarity, and compliance. Connect with Abhijeet Satwekar: LinkedIn: https://www.linkedin.com/in/abhijeetsatwekar Next step: Book a free consultation to help you get started on any questions you may have about bioprocessing development: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
167: How Generative AI Is Revolutionizing Biotech Regulatory Compliance with Abhijeet Satwekar - Part 1 13:30

17 days ago13:30

13:30

Ever feel like you’re drowning in an ocean of constantly shifting regulatory guidelines? The world of biotech is a whirlwind of evolving standards, making compliance not just a headache, but sometimes the stumbling block between life-changing therapies and the patients who need them. But what if artificial intelligence could turn regulatory chaos into your biggest competitive advantage? In this episode, David Brühlmann sits down with Abhijeet Satwekar, Innovation Manager at Merck KGaA’s Global Analytical Development. Abhijeet shares how he’s pioneering the use of generative AI, not as a hype machine, but as a practical, transformative tool for regulatory compliance in biotech. With over a decade navigating analytics, digitalization, and collaborative tech adoption at a major pharma leader, Abhijeet knows what it takes to connect industry stakeholders, harness new technologies, and turn business operations into streamlined, value-generating systems. Here are three reasons you won’t want to miss this episode: Generative AI as a Compliance Powerhouse: Discover how AI is being harnessed to analyze, extract, and compare complex regulatory requirements across different countries, cutting through ambiguous language and shifting specifications - so you don’t have to. Reducing Regulatory Bottlenecks: The days of manually reconciling guideline documents and updating baselines with every regulatory change are numbered. Learn how generative AI accelerates multi-guideline comparison, saving teams countless hours and reducing the risk of costly errors and delays. A Blueprint for Digital Transformation: Abhijeet reveals how Merck is moving from proof-of-concept to operational reality, building collaborative teams that bridge IT, analytics, regulatory, and quality to bring valuable digital tools into daily practice. Curious if your team could automate away regulatory headaches? Listen in and get inspired to tackle your toughest compliance challenges - before your competitors do. Connect with Abhijeet Satwekar: LinkedIn: https://www.linkedin.com/in/abhijeetsatwekar Next step: Book a free consultation to help you get started on any questions you may have about bioprocessing development: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
166: Why Your Funding Pitches Fail Despite Brilliant Science (And How to Fix It) - Part 2 17:02

22 days ago17:02

17:02

Have you ever presented a major scientific breakthrough, only to be met with blank stares and distracted executives? You're not alone. In this episode, David Brühlmann shares how he went from drowning in data to winning an innovation contest, not through better tech, but through the power of scientific storytelling. Many scientists default to methods and data, but as David notes, “ it’s like being fluent in a language nobody else in the room speaks. ” Without a clear link to human impact, even the most brilliant work can go unnoticed. Key insights from the episode that could transform your next presentation: The Three-Act Structure: Storytelling That Resonates - David shows how Apple’s iPhone launch used this classic structure, and how scientists can do the same. Start with “why” (impact), then move to “how” (the science) to keep your audience engaged without losing rigor. Turning Your Audience Into the Hero : Adapting Donald Miller’s framework, David flips the script: your audience is the hero, and your innovation is their guide. It’s about speaking to their needs, not just showcasing your work. Why Storytelling Works: The Neuroscience Edge : Stories release dopamine (focus), oxytocin (trust), and endorphins (emotion) - activating how we naturally learn and remember. It’s not fluff; it’s brain science. Decision-makers won’t remember your chromatogram, but they will remember the story and its impact. The real test of your pitch? Whether it drives action: follow-up meetings or funding. You don’t need to simplify your science. You need to spotlight what matters most to your audience. With a strong narrative, your work stops being overlooked potential and starts becoming real-world impact. Ready to revolutionize your next presentation? Lean into the power of storytelling - your data, your career, and the lives you touch will thank you. Listen to the full episode to explore the straightforward storytelling structure David uses to bring scientific ideas to life. 🔗 Book a free 20-minute consultation with Brühlmann Consulting to answer any questions you may have about how to craft a compelling scientific story that connects and inspires. https://bruehlmann-consulting.com/call/ 🔗 Turn Your Science into Funding Success. Book a 30-minute strategy session to transform your technical pitch into a compelling story that gets funded. Limited spots available. Schedule now at https://stan.store/SmartBiotech/p/turn-science-into-funding-a-pitch-that-sells Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
165: Why Your Funding Pitches Fail Despite Brilliant Science (And How to Fix It) - Part 1 18:44

24 days ago18:44

18:44

Have you ever poured months of research into a brilliant innovation, only to watch executives’ eyes glaze over during your presentation? You’re not alone. In this episode, host David Brühlmann describes a familiar frustration: scientists are trained to perfect data, not to sell ideas. But in today’s fast-paced biotech landscape, even the most groundbreaking technology risks fading into obscurity if it isn’t communicated effectively. Here’s what you’ll learn in this episode: Why Good Science Needs Great Storytelling : David Brühlmann shows that the most funded projects are often the best-communicated, because even experts remember stories, not raw data. A thrift-store experiment proves the point: stories can increase value by over 6,000%. Neuroscience: The Biology Behind the Narrative : Neuroscience shows that suspense, empathy, and humor trigger brain chemicals that boost attention, trust, and memory. That’s why even experts remember stories far more than data dumps. Bridging Science and Story, Without Sacrificing Integrity: Many scientists fear storytelling undermines rigor, but David argues the opposite: story is the map, data the landmarks. Emotion doesn’t weaken science, it makes it resonate and stick. Listen to the full episode to explore the straightforward storytelling structure David uses to bring scientific ideas to life. Don’t let your breakthrough ideas get buried in jargon and dense slides. Your science deserves to be heard—and you already have what it takes to tell a story that sticks. Need help with an upcoming presentation? 🔗 Book a free 20-minute consultation with Brühlmann Consulting to answer any questions you may have about how to craft a compelling scientific story that connects and inspires. https://bruehlmann-consulting.com/call/ 🔗 Turn Your Science into Funding Success. Book a 30-minute strategy session to transform your technical pitch into a compelling story that gets funded. Limited spots available. Schedule now at https://stan.store/SmartBiotech/p/turn-science-into-funding-a-pitch-that-sells Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
164: How Moss Enables Production of Unproducible Protein Therapeutics with Andreas Schaaf - Part 2 19:17

29 days ago19:17

19:17

From lab curiosity to commercial reality. Here's what happens when moss meets the brutal economics of bioprocessing. In Part 1, you've heard the science behind moss-based protein production. Now comes the real test: Can it survive the gauntlet of regulatory scrutiny, cost pressures, and manufacturing scale-up that crushes most biotech innovations? In Part 2 of this groundbreaking conversation, David Brühlmann and Andreas Schaaf, Managing Director and CSO of Eleva, dive into the nuts and bolts of what it actually takes to commercialize a revolutionary production platform. Andreas doesn't just theorize—he's lived through 15+ years of transforming Eleva from startup concept to clinical-stage reality, navigating every regulatory hurdle and economic challenge along the way. Three game-changing advantages that caught our attention: Process Robustness That Actually Works: While CHO cells throw tantrums over minor parameter shifts, moss maintains consistent product quality even when your bioprocess isn't behaving perfectly; a lifeline for manufacturing teams dealing with real-world variability. Economics That Make CFOs Smile: Forget expensive viral filtration steps and costly human pathogen testing. Moss's plant heritage eliminates these animal-system burdens, directly impacting your bottom line in ways that matter. Operational Simplicity: Variability in process ingredients and streamlined cell banking contribute to long-term cost and operational efficiencies that compound over time. Andreas shares hard-won insights about what it really takes to challenge entrenched bioprocessing orthodoxy, including the regulatory conversations, the economic realities, and his advice for scientists brave enough to pursue game-changing innovations. Ready to understand how disruptive biotechnology actually makes it from bench to bedside? Connect with Andreas Schaaf: LinkedIn: www.linkedin.com/in/andreas-schaaf-b3797716 Website: www.elevabiologics.com Next step: Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/ Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
163: How Moss Enables Production of Unproducible Protein Therapeutics with Andreas Schaaf - Part 1 23:48

4 weeks ago23:48

23:48

What if the future of "impossible" protein therapeutics is hiding in your backyard? For decades, CHO cells have ruled the biotech kingdom as the undisputed champions of complex protein production. But here's the uncomfortable truth: countless breakthrough therapies are gathering dust on laboratory shelves—not because the science failed, but because traditional hosts can’t produce them. Enter moss. Yes, moss. That humble green organism clinging to rocks and trees might just be the biotech industry's best-kept secret. In this eye-opening episode, David Brühlmann sits down with Andreas Schaaf, Managing Director and CSO of Eleva, who's spent over 20 years turning the "impossible" into reality. Andreas didn't just stumble upon moss; he co-developed Eleva's revolutionary moss-based platform from wild concept to commercial-scale game-changer, propelling the company into clinical trials. Here are three reasons why this episode is worth listening to: Moss as a Game Changer: More than a plant, moss is a higher eukaryote with mammalian-like protein production, including post-translational modifications and human-compatible glycosylation. Overcoming Bioprocessing Barriers: CHO cells are the industry gold standard, especially for monoclonal antibodies. But what about the therapeutic proteins that CHO can’t handle? Many promising candidates end up shelved—not because the science isn't sound, but because existing production platforms hit their limits. Bioprocessing, Simplified: Moss grows in standard bioreactors using familiar workflows—just with a whole organism instead of suspended cells. Curious about how plant-based systems could solve your protein production challenges? Dive into this episode to discover how moss could revolutionize your approach to challenging proteins; and let us know about your own production hurdles. Connect with Andreas Schaaf: LinkedIn: www.linkedin.com/in/andreas-schaaf-b3797716 Website: www.elevabiologics.com Next step: Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/ Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
162: How to Achieve 85%+ Cell Recovery Without DMSO's Toxic Side Effects with Jeffrey Allen - Part 2 15:35

5 weeks ago15:35

15:35

The world of cell therapy is changing rapidly, with revolutionary advancements in cryopreservation and bioprocessing protocols leading the way. In a recent episode of the Smart Biotech Scientist Podcast, host David Brühlmann sat down with Jeffrey Allen, Chairman and CEO of Evia Bio, to dive deep into the “how” of implementing cutting-edge techniques in the lab and the strategic mindset needed to move therapies from concept to clinic successfully. Jeffrey Allen is a passionate leader with a diverse background in shaping strategy, building high-performing teams, and driving exceptional results across public and private equity-backed organizations. With extensive C-level and international experience in the life sciences sector, Jeffrey has a proven track record of transforming performance and delivering profitable growth in various market environments. Here are three key takeaways for anyone passionate about advancing biotech: The four-step audit: bridging best practices and real-world results: Depending on client needs, the audit is performed either at the client’s laboratory or at Evia Bio’s own facility, ensuring real-world practices are scrutinized and optimized. Protocols matter and so does execution: Even the best-written protocols can falter if not followed meticulously. Regular process audits, sometimes conducted onsite by external partners, help identify “protocol creep” and ensure teams are consistently implementing best practices. Culture fuels innovation: Jeffrey’s leadership advice resonated-aligning on strategy, fostering unified company culture, and surrounding yourself with talented people accelerates growth. Passion for the mission, combined with a strong, diverse team, can deliver both exceptional results and lasting employee engagement. Curious how these insights could save you months of frustration and millions in development costs? Tune in to the full episode, or get in touch to discuss how process optimization can empower your cell therapy journey! Connect with Jeffrey Allen: LinkedIn: www.linkedin.com/in/jeffreydallen2 Website: www.eviabio.com Email: jeffrey.allen@eviabio.com Next step: Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/ Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
161: How to Achieve 85%+ Cell Recovery Without DMSO's Toxic Side Effects with Jeffrey Allen - Part 1 25:52

5 weeks ago25:52

25:52

If you’ve ever worked in a cell therapy lab or handled biologics, you’ve probably experienced the pitfalls of cryopreservation. We’ve all mourned the loss of precious samples after a freeze-thaw cycle gone wrong or watched viability figures plummet, wondering where it all went awry. In this episode of The Smart Biotech Scientist Podcast, Jeffrey Allen, Chairman and CEO of Evia Bio, shares how nature-inspired solutions are changing the cell preservation game. With a background spanning finance, operations, and leadership across the biotech landscape, Jeffrey brings a unique perspective on bridging science and practical manufacturing needs. Inspired by the survival strategies of Minnesota’s frozen forests, a new wave of biotech innovation is transforming the way we freeze, store, and ship life-saving cells for therapies - and it all starts with a better understanding of nature. Here are the top three takeaways from this podcast episode: Cryopreservation shouldn’t be an afterthought: Building optimal cryopreservation strategies into your process development from day one can avoid costly setbacks and delays. Beyond cell viability - function matters: It’s not just about how many cells survive the freeze/thaw cycle, but whether those cells remain fully functional. Evia Bio’s new DMSO-free formulations are delivering >85% recovery on MSCs without compromising cell function. One size doesn't fit all: Every cell type has unique needs for freezing, thawing, and formulation. Leveraging tailored algorithms and customized protocols can drastically improve yield and reproducibility, potentially reducing the need for costly overfilling in manufacturing. If you’ve ever lost precious cell samples to a freeze-thaw mishap or questioned why you’re stuck with outdated, toxic cryopreservation methods, this episode is for you! Connect with Jeffrey Allen: LinkedIn: www.linkedin.com/in/jeffreydallen2 Website: www.eviabio.com Email: jeffrey.allen@eviabio.com Next step: Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/ Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
160: The Ultimate Guide to Accelerating Perfusion Process Development Using 96-Deep-Well Plates with Tom Valentin - Part 2 18:19

6 weeks ago18:19

18:19

In this concluding episode of our deep dive into miniaturized perfusion systems, we tackle the most challenging aspect: implementing meaningful process analytical technology (PAT) at microscale while keeping costs realistic for high-throughput applications. Tom Valentin, group leader at CSEM for Automated Sample Handling, continues sharing CSEM's pioneering work in automated sample handling, revealing both the breakthrough opportunities and stubborn technical barriers that define the current state of small-scale perfusion development. Critical insights you'll gain from this episode: The PAT miniaturization challenge is about more than size: While optical density sensors work reasonably well for microbial cultures, mammalian cell applications demand more sophisticated solutions. Tom explains why viable cell density remains the "holy grail"—and how promising technologies from companies like IMEC and Inspec are pushing the boundaries, though cost-effective 96-well implementation remains elusive Smart compromises can unlock practical solutions: Tom reveals why the industry may need to accept hybrid approaches—real-time pH and DO monitoring combined with once-daily viable cell density sampling. He also explains the unique challenges of sensor positioning in shaking deep-well plates where liquid dynamics create measurement complexities Partnership models that actually work for biotech innovation: Beyond the technical discussion, Tom outlines CSEM's proven collaboration approaches, including how Innoswiss funding can provide 50% cost reduction for development projects and why their 70% proposal success rate makes them an attractive R&D partner for both startups and established pharma companies Discover how bioprocessing is evolving - from high-throughput screening to digital twins and continuous manufacturing- in these expert-led episodes. Episode 155 : From Process Bottlenecks to Seamless Production: How Continuous Bioprocessing Changes Everything Episodes 153-154 : The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago Matos Episodes 85-86 : Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo Morbidelli Episodes 73-74 : Bead-Based Assays: The Power of High-Throughput Screening with Sebastian Giehring Connect with Tom Valentin: LinkedIn: www.linkedin.com/in/tom-valentin-5bb9091b Website: www.csem.ch/en Email: thomas.valentin@csem.ch Next step: Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/ Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
159: The Ultimate Guide to Accelerating Perfusion Process Development Using 96-Deep-Well Plates with Tom Valentin - Part 1 22:30

6 weeks ago22:30

22:30

In bioprocess development, the ability to rapidly screen conditions and predict scale-up performance can mean the difference between a successful therapy launch and costly delays. Today's Smart Biotech Scientist episode features Tom Valentin from CSEM, who's pioneering revolutionary approaches to miniaturized perfusion systems that could transform how we develop biologics. Tom is a group leader at CSEM for Automated Sample Handling within the Life Sciences and Industry 4.0 business unit. As a mechanical and biomedical engineer, he brings a unique cross-disciplinary perspective to solving bioprocessing's most challenging miniaturization problems. What makes this conversation essential listening: 96-deep-well plates are revolutionizing perfusion development: Tom reveals how CSEM's innovative fluidic lids enable continuous medium exchange in 300-microliter volumes, potentially allowing up to 96 parallel perfusion experiments with automated liquid handlers and shaker incubators Three critical barriers still need solving: Despite the promise, Tom identifies the key technical challenges that must be overcome: ultra-low flow rate liquid handling (imagine exchanging 300 μL over 24 hours), effective cell retention in miniaturized systems, and cost-effective real-time biomonitoring that fits within well plate constraints The future of process development is automated and intelligent: From pressure-over-liquid systems to advanced sensor integration, Tom outlines how companies can achieve near-autonomous perfusion screening—but warns that current sensing limitations mean viable cell density monitoring remains the "holy grail" of small-scale perfusion This isn't just about smaller equipment—it's about fundamentally changing how we approach process development. If you're working in cell culture optimization, process scale-up, or bioprocess automation, Tom's insights reveal both the tremendous opportunities and practical realities of implementing next-generation perfusion systems. For biotech professionals, staying ahead means embracing these high-throughput, data-rich models, allowing smarter, faster, and more predictive process development for the therapies of tomorrow. Discover how bioprocessing is evolving - from high-throughput screening to digital twins and continuous manufacturing- in these expert-led episodes. Episode 155 : From Process Bottlenecks to Seamless Production: How Continuous Bioprocessing Changes Everything Episodes 153-154 : The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago Matos Episodes 85-86 : Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo Morbidelli Episodes 73-74 : Bead-Based Assays: The Power of High-Throughput Screening with Sebastian Giehring Connect with Tom Valentin: LinkedIn: www.linkedin.com/in/tom-valentin-5bb9091b Website: www.csem.ch/en Email: thomas.valentin@csem.ch Next step: Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/ Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
158: How to Detect Endotoxins Without Bleeding a Single Horseshoe Crab with Anika Hoffmann - Part 2 16:25

7 weeks ago16:25

16:25

In this concluding episode of our series on revolutionary endotoxin detection, we continue our conversation with Anika Hoffmann about transitioning from theory to practice in the quest for more reliable, sustainable testing methods. Anika is a postdoctoral researcher in analytical chemistry at HES-SO Valais-Wallis, Switzerland. Having established why traditional LAL testing falls short in Part 1, we now explore how Anika's innovative KDO-based chemical analytical approach compares in real-world applications: Greater accuracy you can trust: The new method delivers impressive 5-10% coefficient variation (compared to LAL's 25%), works across broader pH and formulation conditions, but is still working toward the sensitivity targets needed for all pharmaceutical applications Clear path to regulatory acceptance: Anika outlines how companies can validate alternative methods against established standards like LAL, recombinant Factor C, or monocyte activation tests to gain approval from authorities Sustainable testing strategy: Health authorities and customers are increasingly demanding sustainable alternatives as horseshoe crab populations decline while testing demand rises—adopt ethical, animal-free methods now before they become an industry requirement Most excitingly, Anika reveals her entrepreneurial journey from accidental discovery to startup founder. Her passion for solving this critical industry challenge exemplifies how scientists can transform technical innovations into practical solutions that benefit both industry and the environment. Whether you're a bioprocess scientist struggling with endotoxin testing, a quality assurance professional seeking more reliable methods, or someone interested in sustainable alternatives to animal-based testing, this episode provides a clear path toward a future where patient safety doesn't rely on horseshoe crab blood. Listen now to discover how you can implement smarter endotoxin testing at your organization – and reach out to Anika via the links in our show notes if you want to be among the first to access this groundbreaking technology. Connect with Anika Hoffmann: LinkedIn: www.linkedin.com/in/anika-hoffmann-652ab0196/ Email: anika.hoffmann@hevs.ch Next step: Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/ Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
157: How to Detect Endotoxins Without Bleeding a Single Horseshoe Crab with Anika Hoffmann - Part 1 22:38

7 weeks ago22:38

22:38

In biopharmaceutical manufacturing, endotoxins represent a silent but deadly threat – bacterial fragments capable of triggering severe immune responses at picogram levels, potentially leading to septic shock, organ failure, or even death in patients. In this eye-opening first episode, we speak with Anika Hoffmann, a postdoctoral researcher in analytical chemistry at HES-SO Valais-Wallis, Switzerland, who's challenging the decades-old status quo of endotoxin testing. For nearly 50 years, the industry has relied on horseshoe crab blood (LAL assay) despite its significant limitations and sustainability concerns. Anika reveals the troubling truth about traditional testing methods: The LAL reliability problem: With acceptable recovery rates ranging from 50-200% and high variability, can we truly trust our current methods? The "low endotoxin recovery" phenomenon: How common pharmaceutical ingredients can mask dangerous endotoxins, creating false negatives The horseshoe crab sustainability crisis: Rising testing demand threatens declining horseshoe crab populations Most importantly, Anika introduces her groundbreaking alternative: a chemical analytical method targeting KDO, a unique sugar molecule present in all endotoxins. This approach eliminates reliance on enzymes or animal products while providing more consistent results across different pharmaceutical formulations. With regulatory limits as strict as 0.25 EU/mL for water for injection, reliable detection isn't just a quality issue – it's a patient safety imperative. If you're developing biologics, managing bioprocess quality, or navigating regulatory compliance, this episode reveals why rethinking endotoxin testing could be your most important decision. Listen to Part 1 to discover why smarter endotoxin testing is possible without relying on horseshoe crab blood, and stay tuned for Part 2 where we'll explore the practical implementation of this revolutionary approach. Connect with Anika Hoffmann: LinkedIn: www.linkedin.com/in/anika-hoffmann-652ab0196/ Email: anika.hoffmann@hevs.ch Next step: Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at www.bruehlmann-consulting.com/call/ Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
156: The Hidden Economics of Continuous Processing That Most Biotech Companies Overlook 25:45

8 weeks ago25:45

25:45

The world of biologics manufacturing is undergoing a major transformation. Once dominated by traditional batch processes, the industry is now experiencing a marked shift toward continuous bioprocessing. But as companies contemplate this transition, two questions dominate strategic discussions: Will regulators accept continuous manufacturing? And, perhaps more pressingly, Does the business case justify making the switch? In this podcast episode of the Smart Biotech Scientist Podcast, David Brühlmann dives into these pivotal topics - drawing insights from real-world case studies, regulatory updates, and economic analyses. Top three takeaways: Regulators Are On Board: The FDA, EMA, and global agencies now actively support continuous processing when robust controls and monitoring are in place. Real Economic Wins: Cost of goods reductions of up to 35% are possible at certain production scales, with much smaller facilities and lower risk of batch failure. Hybrid & Phased Approaches Work: Companies are finding success by first investing in enabling technologies and gradually transitioning, rather than making sudden changes. Continuous bioprocessing is no longer an experimental promise - it’s an evolving standard. With regulatory bodies championing the shift, real-world implementations proving technical and economic viability, and strong financial incentives for the right manufacturers, the transition becomes not a question of “if,” but “when.” Curious how continuous manufacturing can fit into your strategy? Listen to this episode and share your thoughts or questions! Next step: Transform your bioprocess development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/call Ready to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
155: From Process Bottlenecks to Seamless Production: How Continuous Bioprocessing Changes Everything 24:09

8 weeks ago24:09

24:09

In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann dives into continuous bioprocessing - a major shift in biologics manufacturing that's turning traditional batch processes into streamlined, real-time operations. Imagine running your biologics process non-stop for 30 days, with smart monitoring and smaller, more efficient systems replacing massive reactors. It’s not just possible - it’s already happening across the industry, from Amgen’s 80% smaller facility to Sanofi’s modular "Factory of the Future." David explores how companies - big and small - are increasing productivity, cutting costs, and reducing waste through continuous strategies. You'll also hear about enabling technologies, phased implementation approaches, and the challenges teams are navigating as they make the shift. Top 3 Takeaways: Efficiency & Cost Savings Are Real: Amgen’s results speak volumes: 80% smaller footprint, faster deployment, and cost reductions of over 60% per gram of protein. It’s Not Just for Big Pharma: Small and mid-sized biotechs are embracing continuous processes to stay competitive - gaining speed, flexibility, and lowering production costs without massive infrastructure. You Don’t Have to Go All In: Challenges like cost, complexity, and workforce readiness exist - but many companies are succeeding with hybrid models, applying continuous techniques step-by-step. What’s your take on continuous manufacturing? Tune in, share your thoughts, and join the conversation about the future of biotech production. Next step: Transform your bioprocess development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/call Ready to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
154: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago Matos - Part 2 16:16

9 weeks ago16:16

16:16

In this episode, Tiago Matos, Associate Principal Scientist/Associate Director in Bioprocess Drug Substance and Commercialization at Merck & Co., shares a critical insight: continuous manufacturing in biologics currently demands 2–3x more time and FTEs than traditional fed-batch approaches. This highlights both the complexity of the shift - and the urgency for smarter digital tools and cross-functional collaboration. With over a decade of experience and a strong track record in biologics and smart manufacturing, Tiago brings a balanced view of the promise and practical challenges of digital transformation in bioprocessing. Top 3 Takeaways: Continuous Manufacturing is Coming - But Slowly : The infrastructure and tools aren’t fully ready. Progress depends on better-integrated solutions and stronger collaboration across industry, equipment providers, and regulators. Collaboration is Key : No one drives transformation alone. Digital, automation, modeling, and process experts must work together - like building a functional protein from diverse amino acids. Digital Twins and AI Will Bridge the Gap : AI, soft sensors, and digital twins will help streamline control strategies. The goal isn’t perfect models, but reliable, adaptive systems that improve in real time. Tiago’s vision is both realistic and inspiring: the future of biologics manufacturing lies in openness, teamwork, and continuous learning. What challenges or questions do you face in the shift to digital bioprocessing? Here is what other guests had to say on this topic: Episodes 5-6: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael Sokolov; Episodes 85-86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo Morbidelli; Episodes 121-122: The Transformative World of Digital Solutions in Bioprocessing with Simon Wieninger. Connect with Tiago Matos: LinkedIn: www.linkedin.com/in/tiagobmatos Merck & Co.: www.merck.com Next step: Transform your bioprocess development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/call Ready to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
153: The Future of Bioprocessing: Industry 4.0, Digital Twins, and Continuous Manufacturing Strategies with Tiago Matos - Part 1 28:58

9 weeks ago28:58

28:58

As the biotechnology sector races toward digital transformation, the buzz around Industry 4.0 - with its promise of interconnected systems, automation, and data-driven operations - has never been louder. But is the industry truly ready? In this episode, we speak with Tiago Matos, Associate Principal Scientist/Associate Director in Bioprocess Drug Substance and Commercialization at Merck & Co., who brings a grounded, insider view. Despite the hype, he says most of biopharma is still operating at an “Industry 3.2” level. With over a decade of experience in biologics and vaccines, Tiago leads teams pushing digital innovation forward - through tools like digital twins, advanced control strategies, and smart manufacturing platforms. Key takeaways from this episode: Biotech is slowly transitioning toward true Industry 4.0, through collaboration and strategic leadership. Digital twins aren’t for everything. Focused use in platform processes yields the best return - broad implementation can be costly and complex. Regulators are ready. Far from being a barrier, they’re encouraging innovation and open to new ideas. Curious to learn more? Check out the full blog post for deeper insights, and let us know your thoughts in the comments - how close do you think biomanufacturing is to a true digital revolution? Here is what other guests had to say on this topic: Episodes 5-6: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael Sokolov; Episodes 85-86: Bioprocess 4.0: Integrated Continuous Biomanufacturing with Massimo Morbidelli; Episodes 121-122: The Transformative World of Digital Solutions in Bioprocessing with Simon Wieninger. Connect with Tiago Matos: LinkedIn: www.linkedin.com/in/tiagobmatos Merck & Co.: www.merck.com Next step: Transform your bioprocess development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/call Ready to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
152: Is an Indian CDMO the Right Move for Your Biologics Pipeline? with Abdelaziz Toumi - Part 2 21:21

10 weeks ago21:21

21:21

Is an Indian CDMO the right move for your biologics CMC development? Pulling back the curtain on what might be your next strategic manufacturing advantage, this episode reveals the hidden capabilities emerging from India that leading biotech companies are racing to access. As supply chain vulnerabilities continue to expose risks in traditional manufacturing models, could the solution lie halfway around the world? Joining us to reveal the inside story is Abdelaziz Toumi, CEO of Lupin Manufacturing Solutions and veteran of global pharma giants like Bayer, Merck and Lonza. With over 20 years in biotech, Abdelaziz brings unique insights on when and why you might want to look beyond traditional Western manufacturing partners. Our host, David Brühlmann, leverages his 15+ years of biotech industry experience to extract the practical insights you need to make informed decisions about your manufacturing strategy. In this second segment, we'll dive deeper into the Indian CDMO and biomanufacturing landscape. Then we'll explore Lupin's specialized capabilities and finally extract Abdelaziz's most valuable leadership insight from his role as a CEO. Key insights from this episode: The One-Stop Solution Advantage: Discover how Lupin is building rare end-to-end manufacturing capabilities for complex modalities like Antibody-Drug Conjugates (ADCs) - potentially eliminating the headache of managing multiple manufacturing partners across continents. Beyond Labor Cost Advantages: "Digitalization plays a key role, especially if you are operating in a cost-competitive space," explains Abdelaziz. Learn how Indian CDMOs are strategically automating key processes to drive both efficiency and quality, challenging Western perceptions. Leadership Across Cultures: "Listen, listen, listen," emphasizes Abdelaziz when discussing cross-cultural leadership. Understand the subtle communication dynamics that can make or break a global manufacturing partnership, especially when navigating hierarchy-sensitive cultures. Whether you're actively evaluating Indian manufacturing options or simply preparing for the shifting global biotech landscape, these next several minutes deliver insights you can't afford to miss. Listen to the full episode to extract the specific capability indicators that will help you determine if and when an Indian CDMO partnership makes strategic sense for your unique biologics pipeline. Want to find out more about the CDMO selection? Here’s what one of our distinguished guests had to say about it: Episodes 103-104 : One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma Mostafa Connect with Abdelaziz Toumi: LinkedIn: www.linkedin.com/in/abdelaziztoumi Lupin Manufacturing Solutions: www.lupin.com Next step: Transform your process development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/call Ready to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
151: Is an Indian CDMO the Right Move for Your Biologics Pipeline? with Abdelaziz Toumi - Part 1 26:57

10 weeks ago26:57

26:57

Is an Indian CDMO the right move for your biologics pipeline? As Western biotech companies seek new strategic advantages, one question keeps surfacing: Is India truly becoming the next biotech manufacturing powerhouse? And what hidden capabilities are emerging that leading companies are racing to access? In this episode of the Smart Biotech Scientist Podcast, Abdelaziz Toumi, CEO of Lupin Manufacturing Solutions and veteran of global pharma giants like Bayer, Merck, and Lonza, joins host David Brühlmann to reveal the inside story on when and why you might want to look beyond traditional Western manufacturing partners. Here are three key insights from their conversation: The Post-Pandemic Manufacturing Revelation: "During the pandemic, we realized how vulnerable our supply chain truly is," explains Abdelaziz. Discover why diversifying manufacturing partnerships isn't just smart—it's becoming essential for resilience in an unpredictable world. Beyond the Cost Advantage: While Indian CDMOs can deliver up to 80% cost savings compared to Western counterparts, Abdelaziz reveals the unexpected advantages that make the most strategic partnerships about far more than budget considerations. The Trust Factor: "This is a business of trust," emphasizes Abdelaziz. Learn the critical questions that separate world-class Indian CDMOs from the rest, and the cultural nuances that can make or break your manufacturing partnership. Ready to discover if Indian CDMOs could be the missing piece in your biologics development strategy? Tune in for expert insights on IP protection, talent access, and how to navigate the cultural dynamics that determine success in this emerging manufacturing powerhouse. Listen to the full episode to unlock the strategic advantage that could transform your pipeline's journey from lab to market. Want to find out more about the CDMO selection? Here’s what one of our distinguished guests had to say about it: Episodes 103-104 : One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma Mostafa Connect with Abdelaziz Toumi: LinkedIn: www.linkedin.com/in/abdelaziztoumi Lupin Manufacturing Solutions: www.lupin.com Next step: Transform your process development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/call Ready to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
150: How to Leverage AI in Media Development Without Sacrificing Process Understanding with Tom Fletcher - Part 2 24:04

11 weeks ago24:04

24:04

As biotech labs rush to adopt AI tools for cell culture media development, a critical question emerges: Are we creating a generation of scientists who know which buttons to push but not why they're pushing them? The automation trap that once transformed laboratory workflows now threatens to fundamentally alter how we understand the complex dynamics of culture media composition and performance. In this second part of our conversation with Tom Fletcher, R&D Director at Fujifilm Irvine Scientific, host David Brühlmann explores the practical challenges of implementing AI in cell culture media development while preserving the scientific thinking that drives true innovation. Key Insights from Their Conversation: The Knowledge Generation Imperative: "Don't just think of your job as picking winners out of random experiments," Tom warns. He emphasizes that scientists must prioritize understanding why a specific media formulation works, not just that it works—a distinction that becomes critical as AI makes high-throughput media screening increasingly accessible. Bridging Disciplinary Divides: As teams become more diverse—incorporating data scientists, automation specialists, and traditional bioprocess experts—success depends on creating a collaborative culture where specialists learn to leverage each other's strengths without expecting everyone to have the same foundation in cell culture fundamentals. The Future Bioprocessing Landscape: Tom predicts that while platform media will dominate for speed to clinic, human roles will evolve toward managing automated, digitalized processes with fewer but more technically specialized staff. The media developers who thrive will be those who can maintain scientific rigor while harnessing the power of automation. For biotech leaders navigating this technological transition, Tom's advice is clear: "Embrace AI because I think we all believe it's valuable, but don't allow lazy science to creep in... if you don't resist it, people are going to get lazy and just say 'I've got this supercomputer and I know which buttons to push.' That's not good enough." If you enjoyed this conversation, be sure to explore how it all began: Episodes 1-2: Unlock the Power of Rational Media Design in Bioprocessing with Tom Fletcher Connect with Tom Fletcher: LinkedIn: www.linkedin.com/in/tomfletcher2 FUJIFILM Irvine Scientific: www.irvinesci.com The views and opinions expressed by Tom Fletcher are his own and do not necessarily reflect those of Fujifilm Irvine Scientific or its affiliates. Next step: Transform your cell culture media development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/call Ready to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech Note: These are Tom’s personal opinions and not his company’s. Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
149: How to Leverage AI in Media Development Without Sacrificing Process Understanding with Tom Fletcher - Part 1 18:27

11 weeks ago18:27

18:27

From closely-guarded secrets to complex chemical interactions, cell culture media development has transformed from an afterthought to a critical competitive advantage in modern bioprocessing. But as AI and automation revolutionize the field, are we at risk of gaining speed while losing understanding? In this eye-opening episode of the Smart Biotech Scientist Podcast, host David Brühlmann speaks with Tom Fletcher, R&D Director at Fujifilm Irvine Scientific, who brings over 30 years of experience and a unique perspective on balancing technological innovation with scientific rigor. Key Insights from Their Conversation: The Evolution of Media Formulations: Tom traces the remarkable journey from basic serum supplements to today's chemically defined media with 60-70+ precisely balanced components, transforming what was once "just that stuff you bought" into one of bioprocessing's most closely guarded competitive advantages. The Collaborative Intelligence Framework: The most powerful approach combines artificial intelligence with human intelligence (AI + HI = CI), where technology enhances rather than replaces scientific thinking to generate not just data, but genuine process understanding. Avoiding the Automation Trap: "Don't get lazy with technology," Tom warns, emphasizing that the goal remains generating knowledge about why processes work, not just identifying which conditions perform best—a crucial mindset as companies increasingly adopt powerful AI tools. If you enjoyed this conversation, be sure to explore how it all began: Episodes 1-2: Unlock the Power of Rational Media Design in Bioprocessing with Tom Fletcher Connect with Tom Fletcher: LinkedIn: www.linkedin.com/in/tomfletcher2 FUJIFILM Irvine Scientific: www.irvinesci.com The views and opinions expressed by Tom Fletcher are his own and do not necessarily reflect those of Fujifilm Irvine Scientific or its affiliates. Next step: Transform your cell culture media development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/call Ready to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
148: Lab-Grown Blood: How Stem Cells Transform Transfusions with Ari Gargir - Part 2 16:17

12 weeks ago16:17

16:17

In the wake of the COVID-19 pandemic, the fragility of global blood supply systems became undeniably clear. Recognizing the urgent need for a more reliable and universal solution, Ari Gargir and his team at RedC Biotech are leading an ambitious effort to transform blood supply as we know it. Their mission? To develop lab-grown red blood cells that not only address chronic shortages but also overcome blood type compatibility - an innovation with the potential to reshape modern medicine. As the CEO and founder of RedC Biotech, Ari brings a powerful personal story to this mission. After a near-fatal paragliding accident, a life-saving transfusion ignited his determination to create a scalable, donor-free blood alternative. Now, through pioneering bioprocessing techniques, he and his team are working to produce universal red blood cells that could serve nearly anyone, anywhere. In this episode, we explore: Bioprocessing Breakthroughs: How RedC Biotech transforms stem cells into red blood cells - scaling from lab flasks to industrial bioreactors - and the key challenges in making this process scalable and cost-effective. Quality and Cost Challenges: The rigorous standards for safety, efficacy, and affordability, and how RedC Bioteh is tackling them to produce viable blood units at scale. Why Now? - Ari shares why this moment is uniquely suited for breakthroughs in blood biotech, thanks to recent advancements in Induced pluripotent stem cell (iPSC) technology and hard lessons learned from COVID-19. Listen to the full episode for Ari’s insights and advice for biotech entrepreneurs navigating bold, high-impact innovations. Connect with Ari Gargir: LinkedIn: www.linkedin.com/in/ari-gargir-7107035 RedC Biotech: www.redcbiotech.com Next step: Transform your bioprocess development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/call Ready to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
147: Lab-Grown Blood: How Stem Cells Transform Transfusions with Ari Gargir - Part 1 22:01

12 weeks ago22:01

22:01

Blood is critical to global healthcare - vital for surgeries, trauma care, cancer treatment, and maternal health. Yet despite 120 million donations each year, a 100 million unit shortfall means nearly half the world’s needs go unmet. One person who understands this crisis firsthand is Ari Gargir, CEO & Founder of RedC Biotech. After surviving a paragliding accident thanks to a life-saving transfusion, he set out to tackle the global blood shortage. His team is now developing universal, lab-grown red blood cells, eliminating the need for donors. The added transitional phrase creates a smoother flow between the global problem and the personal story that follows. Don’t miss these key insights from the full conversation: The Global Crisis: Ari painted a vivid picture of the current state of blood supply. The problem is multifaceted - logistical issues, biological challenges, and socio-economic disparities in blood distribution exacerbate this shortage. Developed nations possess more blood resources, but low-income countries, where donation rates are staggeringly low, continually grapple with severe shortages. Innovative Solutions: We learned about the groundbreaking technology Ari is developing at RedC Biotech. Using stem cells, they aim to create unlimited, universal, and donor-free red blood cells. This could be a game-changer, not only for transfusions but also for advanced therapeutic uses. Impact on Healthcare : Ari is a strong advocate for O-negative blood, which can be used for up to 98% of people. But he’s especially focused on vulnerable patients - those with sickle cell disease, thalassemia, and complex immune conditions - who may need frequent transfusions. Our conversation with Ari underscores the importance of innovation in biotechnology to address critical global healthcare issues. By creating a reliable, scalable supply of red blood cells, RedC Biotech holds the promise of saving countless lives and improving the quality of life for those dependent on regular blood transfusions. Tune in to hear how Ari and RedC Biotech are shaping the future of transfusion medicine. Connect with Ari Gargir: LinkedIn: www.linkedin.com/in/ari-gargir-7107035 RedC Biotech: www.redcbiotech.com Next step: Transform your bioprocess development strategy with a complimentary consultation. Schedule your expert session: https://bruehlmann-consulting.com/call Ready to scale up? Join our exclusive 1:1 Strategy Call and learn proven methods to reduce development and manufacturing costs while maintaining product quality. Our bioprocess experts will help you navigate complex bioprocessing challenges and regulatory requirements. Limited spots available: https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
146: Beyond ELISA: The 10-Minute Immunoassay Enabling Real-Time Bioprocess Control with Bruno Oesch - Part 2 18:09

13 weeks ago18:09

18:09

Stuck with outdated analytics while trying to develop cutting-edge therapies? Part 2 of our conversation with Bruno Oesch, CEO and founder of Elionova, reveals how biotech scientists can finally break free from incremental improvements and embrace the revolutionary immunoassay technology that's transforming bioprocessing workflows worldwide. For years, ELISA (Enzyme-Linked Immunosorbent Assay) has been vital in biotechnology, but its time-consuming protocols and complex washing steps slow bioprocess development, creating bottlenecks in advancing therapies. Bruno's team is transforming the field of immunoassays with an innovative technology that delivers quantitative results in just 10 minutes—without the need for washing steps. Here are three key takeaways from the conversation: Market Introduction Strategy : Bruno emphasizes the importance of placing the product directly in the hands of potential customers. By offering free trials, users can experience its value firsthand, creating a strong incentive for continued use. Building an Open Community : Elionova fosters a collaborative environment where users can develop and share assays. Their vision follows an app store model, encouraging innovation and knowledge exchange within the biotech space. Vision for the Future : Beginning with research labs, Elionova aims to expand into diagnostics, particularly in veterinary medicine, due to lower regulatory hurdles. Their long-term goal is to make a significant impact in point-of-care diagnostics, offering rapid results crucial for emergency medical scenarios. If you're a biotech professional looking to streamline bioprocess workflows and drive innovation, Bruno Oesch’s transformative approach may provide the inspiration you need. Stay ahead of industry advancements by tuning into this episode to learn more about connecting with Oesch and exploring Elionova’s novel technology. Connect with Bruno Oesch: LinkedIn: www.linkedin.com/in/bruno-oesch Elionova: www.elionova.com Next step: Ready to revolutionize your bioprocess workflows? Book a free consultation at https://bruehlmann-consulting.com/call to discover how real-time analytics can transform your development timeline. Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
145: Beyond ELISA: The 10-Minute Immunoassay Enabling Real-Time Bioprocess Control with Bruno Oesch - Part 1 27:19

13 weeks ago27:19

27:19

Tired of waiting overnight for ELISA results? Serial entrepreneur Bruno Oesch reveals how his groundbreaking 10-minute immunoassay technology is eliminating the biggest bottleneck in bioprocessing workflows. From contributing to Nobel Prize-winning prion research to founding Prionics (the first commercial BSE test) and now revolutionizing immunoassays with Elionova, Bruno transforms high-end science into practical solutions that work for everyday labs. Here are three takeaways from this podcast episode: ELISA - The Lab Workhorse That Still Matters : Since the 1970s, ELISA assays have been a cornerstone of bioprocessing and diagnostics. As Bruno Oesch puts it, they remain the "workhorses of biochemical labs." Despite requiring over four hours of binding and washing steps, ELISA remains widely used for its affordability and reliability. However, its slow, linear workflow calls for innovation. ElioDX - The Next-Gen Immunoassay : While Elionova didn’t invent evanescence, they’ve made it accessible and practical. Instead of lengthy washes, a laser-generated evanescent field enables real-time detection, delivering results in just 10 minutes by measuring signal changes dynamically. The Future of Real-Time Bioprocessing: This breakthrough eliminates bottlenecks in biotech workflows. By integrating real-time analysis, ElioDX enhances efficiency, decision-making, and continuous bioprocessing, ensuring precise insights exactly when they’re needed. As David and Bruno highlight, the future of immunoassays isn’t just about innovation - it’s about making these advancements practical and transformative across the industry. By bridging science and accessibility, leaders like Bruno Oesch play a crucial role in demystifying bioprocessing, sparking impactful discussions, and driving real change in the scientific community. Listen to the full discussion to explore how this real-time approach can streamline bioprocessing and transform your workflows. Connect with Bruno Oesch: LinkedIn: www.linkedin.com/in/bruno-oesch Elionova: www.elionova.com Next step: Book a free consultation to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
144: The Future of Biotech: Making Biotherapeutics More Accessible Faster 12:55

14 weeks ago12:55

12:55

Imagine a future where every patient can access life-saving therapies and sustainable, high-quality food is within everyone’s reach. In this episode of the Smart Biotech Scientist , David Brühlmann explores how innovative biotech developments are making this vision a reality. Here’s a sneak peek of the breakthroughs covered: AI-Powered Picoliter Scale Testing : Discover how companies like Triple Bar Bio are pushing the boundaries of what's possible with their innovative microfluidic technology that screens individual cells. Their approach enables rapid identification the best cell producers, paving the way for more efficient and precise bio-manufacturing. Hybrid Models for Process Prediction : Learn about DataHow's cutting-edge hybrid models that predicts process outcomes and improves product quality. Their models have demonstrated the potential to reduce the number of experiments by up to 80%. Unconventional Bioreactor Approaches : Explore an intriguing proposition – could tomorrow's bioreactors be living organisms like goats? BioSourcing is exploring the potential of transgenic goats to produce biopharmaceuticals more affordably, a concept that could dramatically lower production costs and enhance accessibility. The future of biotech is not just about technological advancement; it’s about embracing the impact these innovations can have globally. As David urges, the challenge is no longer about if these changes will happen, but how quickly we can achieve them. Stay curious, keep innovating, and be part of this exciting transformation in biotech. Your contributions and feedback could shape the next generation of breakthroughs. Listen, learn, and let us know what you think about these advancements. We can’t wait to hear from you! If you enjoyed this, here are some episodes worth listening: Episode 135: Beyond Breakthroughs: Making Biotherapeutics Affordable for All Episode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them) Episodes 127-128: The 7 Hidden Innovation Habits That Top Biotech Scientists Use Daily Episode 87: The Hidden Pitfalls of Bioprocess Development: Lessons from the Trenches Episodes 41-42: Revealing the Disciplined Pursuit of Less in Bioprocessing Next step: Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free consultation to propel your success: https://bruehlmann-consulting.com/call Develop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
143: Bioprocess Breakthroughs: How Smart Bioprocessing Is Democratizing Life-Saving Treatments 15:32

14 weeks ago15:32

15:32

In the rapidly evolving world of biotechnology, innovation is not just happening at the molecular level. Industry leaders are making groundbreaking advancements in bioprocessing - a crucial component in making life-saving therapies more accessible and affordable. The journey to affordable therapies starts with the production process itself. In this podcast episode, David Brühlmann sheds light on innovations in bioprocess design that are setting new standards in efficiency and efficacy. At the heart of this transformation is the shift from traditional process formats like fed-batch to continuous process formats, quality by design approaches, and the implementation of breakthrough technologies. Here's a quick rundown of the key takeaways: Revolutionary Process Designs : Industry leaders are enhancing bioprocess designs—from antibody production enhancements to integrating perfusion mode. One case study highlighted a dramatic increase in viable cell density and protein titers through intensified processes. Quality Control Innovations : Companies like Cyto-Facto are pioneering quality by design in the challenging cell and gene therapy space. By leveraging sophisticated PAT systems, they can monitor critical process parameters in real-time, ensuring consistent quality even in complex bioprocesses. Metabolite Shifts and Efficacy : A surprising discovery revealed the power of metabolite shifts induced by cell culture media design, inspired by an intriguing study on cyclists, to enhance antibody efficacy and stability. This opens new possibilities for engineering the quality of biopharmaceuticals through simple modifications in the culturing process. The innovations discussed in the Smart Biotech Scientist illustrate a pivotal transformation in bioprocessing. By rethinking process designs and committing to quality control, the biotech industry is paving the way for groundbreaking therapies that are not just dreams but realities - realities that are tangibly more accessible to patients worldwide. As we anticipate more developments in this field, the promise of biotech becomes increasingly certain: a future where life-saving treatments are affordable and available to all who need them. Catch the full episode to explore how these innovations are not just improving efficiency but making life-saving therapies more accessible globally. If you enjoyed this, here are some episodes worth listening: Episode 135: Beyond Breakthroughs: Making Biotherapeutics Affordable for All Episode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them) Episodes 127-128: The 7 Hidden Innovation Habits That Top Biotech Scientists Use Daily Episode 87: The Hidden Pitfalls of Bioprocess Development: Lessons from the Trenches Episodes 41-42: Revealing the Disciplined Pursuit of Less in Bioprocessing Next step: Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free consultation to propel your success: https://bruehlmann-consulting.com/call Develop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
142: How Microalgae Cuts Antibody Costs by 70% and Redefines Biomanufacturing with Muriel Bardor - Part 2 17:06

15 weeks ago17:06

17:06

What if we could revolutionize biotechnology by slashing antibody production costs by 70%? In a world where traditional mammalian cell cultures struggle with scalability and cost-effectiveness, an unexpected hero emerges from the depths of our oceans - microalgae. The use of microalgae in biotechnology is not just a novelty but a necessity, given the current demands for more efficient and cost-effective production methods. Muriel Bardor, co-founder, CEO and CSO of Alga Biologics, highlights a particularly startling statistic: microalgae can reduce the cost of antibody production by an impressive 70%. This innovation could revolutionize the biotechnology industry by making life-saving therapies more accessible. Here are 3 key takeaways from this podcast episode: Quality and Safety Assurance : By collaborating with virology experts and using advanced techniques like mass spectrometry, they ensure that their processes are virus-free and free from host-cell protein contamination. The company is paving the way for future developments despite the challenges of not having standard ELISA kits commercially available. Regulation and Industry Perception: Launching such transformative technology inevitably entwines with regulatory landscapes. Muriel and her company have begun discussions with the French regulatory agency, drawing optimism from the fact that similar plant-based products, such as glucocerebrosidase, have already paved the way in the market. This indicates a growing acceptance within regulatory bodies of alternative bioprocessing platforms, inspiring hope for microalgae's future in antibody production. Future Vision : Muriel hopes to break conservative barriers within pharmaceutical companies and promote the adoption of microalgae production. This offers not only cost-effective solutions but also holds potential for new treatment options, like for neuroblastoma. Check out the episode to hear Muriel's advice for aspiring scientists and the general public alike regarding the future of research and the well-being of our planet. Connect with Muriel Bardor: LinkedIn: www.linkedin.com/in/muriel-bardor-47953024 Email: muriel.bardor@univ-rouen.fr Alga Biologics: www.algabiologics.com Next step: Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
141: How Microalgae Cuts Antibody Costs by 70% and Redefines Biomanufacturing with Muriel Bardor - Part 1 25:15

15 weeks ago25:15

25:15

The world of biologics manufacturing is about to be transformed by a breakthrough that slashes antibody production costs by 70%. This revolutionary approach leverages the untapped potential of microalgae to deliver a sustainable, cost-effective solution that could make life-saving therapeutics more accessible than ever before. Enter microalgae, the star of this groundbreaking development. In this episode of the Smart Biotech Scientist, Muriel Bardor, the co-founder, CEO and CSO of Alga Biologics, shared insights into how her team's pioneering work with microalgae could redefine the landscape of immunotherapy. Here are some takeaways from her conversation with David Brühlmann: Green Revolution in Bioprocessing: Discover how microalgae can slash production costs by 70% and offer a sustainable alternative to traditional antibody manufacturing. Muriel explains how these photosynthetic organisms capture 7 tons of CO2 per kilogram of product - transforming antibody manufacturing both economically and environmentally. Rethinking Antibody Production: Learn why the conventional use of mammalian cells in antibody production is being challenged and how microalgae overcome the limitations of traditional methods, bringing life-saving drugs within reach for more people globally. Sustainable Impact: With a process that mirrors nature, Muriel’s approach sets a new standard for eco-friendly biotech production. Find out how microalgae are changing not just the industry, but our world. We invite you to listen to this insightful conversation and explore how you can apply these groundbreaking ideas to your own work. Has Muriel’s innovative approach inspired you? Share your thoughts or questions with us - we'd love to hear from you! If you are interested in antibody production, here is another episode worth listening: Episodes 47-48: Mastering Process Economics: Driving Down Costs in Antibody Production with Brian Kelley Connect with Muriel Bardor: LinkedIn: www.linkedin.com/in/muriel-bardor-47953024 Email: muriel.bardor@univ-rouen.fr Alga Biologics: www.algabiologics.com Next step: Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call: The quickest and easiest way to excel biotech technology development. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
140: Regulatory Secrets Revealed: Why Your CMC Strategy Could Make or Break Your Biotech Startup with Rivka Zaibel - Part 2 20:42

16 weeks ago20:42

20:42

In this episode, we explore the important steps in preparing for regulatory meetings, address the dangers of cross-contamination in biotechnology facilities, and debunk common misconceptions that could derail your CMC development strategy. As the founder and president of ADRES - Advanced Regulatory Services Ltd., Rivka Zaibel brings over 36 years of industry experience and practical strategies to help navigate the intricacies of CMC development and regulatory compliance. Here are three key takeaways: Risk Assessment is Paramount : Start risk assessments in parallel with facility design to prevent cross contamination. Remember, areas for both mammalian and microbial cells should be segregated to ensure safety. Early Engagement with Regulatory Agencies : Don’t wait until everything is finalized before consulting with regulatory bodies. Engaging them early can ensure your plans align with their requirements and might even spark valuable advice you hadn’t considered. Understand and Plan Your Product Journey : Have a clear vision of your final product from the start, and plan backwards. This approach ensures all supporting processes are adequately addressed, saving time and preventing costly mistakes down the line. Ultimately, successful biologics development hinges on thorough understanding and strategic planning. This includes comprehensive risk assessments, early regulatory engagement, and a commitment to continuous training and facility validation. Rivka's insights offer a roadmap for navigating this complex landscape, aiming to deliver groundbreaking therapies with precision and compliance. By following these expert strategies, biotech professionals can streamline their processes, avoid common pitfalls, and ensure the successful introduction of their products to the market. Connect with Rivka Zaibel: LinkedIn: www.linkedin.com/in/rivka-zaibel/ ADRES - Advanced Regulatory Services Ltd.: www.adres.bio Email: tanya@adres.bio Next step: Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
139: Regulatory Secrets Revealed: Why Your CMC Strategy Could Make or Break Your Biotech Startup with Rivka Zaibel - Part 1 25:21

16 weeks ago25:21

25:21

In biotherapeutic drug development, the journey from discovery to clinic involves navigating a labyrinth of regulatory requirements and strategic considerations, particularly in Chemistry, Manufacturing, and Control (CMC). In this episode of the Smart Biotech Scientist , host David Brühlmann engaged with Rivka Zaibel, President and Founder of ADRES - Advanced Regulatory Services Ltd. - to demystify the regulatory intricacies of biologics development and provide actionable insights for biotech leaders. With over three decades of experience in the biopharmaceutical industry, Rivka Zaibel highlights that understanding the regulatory landscape is crucial for the success of biologics development. Here are three key takeaways from this episode: Prioritize CMC Development Early : CMC (Chemistry, Manufacturing, and Controls) development is crucial in biologics. Rivka emphasizes starting early and engaging with regulatory agencies to avoid costly delays and streamline the bioprocessing journey. Understand Regulatory Differences : Different agencies (FDA vs. EMA) may have varied interpretations of guidelines. Familiarize yourself with ICH guidelines and the specific requirements of each agency to align your strategy effectively. Leverage Existing Resources : Before developing your own product pathway, explore existing European Public Assessment Reports (EPARs) and summary bases of approval for comparable products. This research can provide valuable insights into regulatory expectations and streamline your approach. For startups navigating the complexities of CMC development, Rivka highlights three critical quality and regulatory considerations essential for reaching Phase 1 trials. By embracing these key insights, biotech professionals can streamline the path to delivering innovative therapies to patients safely and efficiently. In conclusion, as you continue your journey within the biopharmaceutical industry, let the Smart Biotech Scientist serve as your guide, demystifying the complexities and empowering you with the tools needed to thrive. Stay informed, stay proactive! Connect with Rivka Zaibel: LinkedIn: www.linkedin.com/in/rivka-zaibel/ ADRES - Advanced Regulatory Services Ltd.: www.adres.bio Email: tanya@adres.bio Next step: Book a free consultation to refine your CMC strategy to propel your success: https://bruehlmann-consulting.com/call Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
138: Skip 90% of Bioreactor Runs: The In Silico Revolution in Bioprocess Development with Yossi Quint - Part 2 20:16

17 weeks ago20:16

20:16

In the fast-evolving world of biotechnology, the pursuit of efficiency and faster development has never been more critical. The computational tools and models currently being integrated into bioprocessing present a groundbreaking approach that promises radical shifts in drug development timelines and capabilities. In the second part of our conversation, Yossi Quint, founder and CEO of Ark, shows us that the horizon of bioprocessing is lined with possibilities that could revolutionize biotherapeutics accessibility, cost, and speed in pharmaceutical innovations. Here are three key takeaways you don't want to miss: De-risking with Simulation : Yossi shared how simulation models can drastically reduce risks by running many scenarios before actual implementation. This approach optimizes processes, lowers costs, and speeds up the development cycle. Transfer Learning in Bioprocessing : Discover the potential of leveraging data across different types of molecules! Although challenging, the ultimate goal is to apply data learnings from one process to others, maximizing efficiency and success rates. Patient Impact & Cost Reduction : At the heart of these innovations is the goal of quicker, more affordable drug production. By slicing down on both time and costs, computational tools not only help drugs reach the market faster but also make them more accessible to patients globally. With innovation at its core, the modern trajectory of bioprocessing is not simply about reaching scientific milestones but about profoundly transforming patient care and accessibility. This synergistic blend of technology and purpose crafts a future in which the biotechnology sector not only grows but also enriches countless lives around the globe. If you are interested in this topic, here are a few standout conversations on AI’s impact on bioprocessing with some incredible experts: Episodes 131-132: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza Farahani Episodes 115-116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy Agresti Episodes 111-112: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars Brandén Episodes 107-108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David Schönauer Episodes 95-96: AI in Bioprocess Development: The Game-Changer You Can't Ignore with Belma Alispahic Connect with Yossi Quint: LinkedIn: https://www.linkedin.com/in/yossi-quint Ark: https://www.ark-biotech.com Next step: Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
137: Skip 90% of Bioreactor Runs: The In Silico Revolution in Bioprocess Development with Yossi Quint - Part 1 21:55

17 weeks ago21:55

21:55

The integration of AI into drug discovery has already led to groundbreaking advancements, uncovering patterns in vast datasets that were previously invisible to human researchers. Now, AI is set to revolutionize bioprocessing as well. In this episode of the Smart Biotech Scientist Podcast , Yossi Quint, founder and CEO of Ark, and David Brühlmann explore how AI and computational tools are reshaping bioprocess development. Yossi envisions a future where 90% of bioreactor experiments could be replaced by in silico simulations , dramatically accelerating time to market and increasing throughput. Key takeaways from the conversation with Yossi Quint: AI’s Role in Drug Discovery & Bioprocessing: AI is already transforming drug discovery by identifying intricate patterns across millions of data points. Now, bioprocessing is undergoing a similar revolution, as computational tools simplify and streamline complex workflows. The Power of Hybrid Models: Yossi highlights the synergy between mechanistic models and AI-driven approaches , emphasizing how AI can fill gaps where traditional models struggle—especially in understanding complex cellular behaviors. Empowering Bioprocess Teams with AI: As AI accelerates drug discovery, bioprocessing must evolve to keep pace. Yossi discusses the importance of digital transformation in ensuring bioprocess teams can meet increasing demands and drive innovation forward. With AI-driven models, hybrid simulations, and increased digitization, the bioprocessing industry stands at the cusp of a new era. The convergence of data, science, and technology promises not only greater efficiency and accuracy but also a faster path to life-saving treatments for patients in need. If you want to learn more, here are a few standout conversations on AI’s impact on bioprocessing with some incredible experts: Episodes 131-132: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza Farahani Episodes 115-116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy Agresti Episodes 111-112: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars Brandén Episodes 107-108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David Schönauer Episodes 95-96: AI in Bioprocess Development: The Game-Changer You Can't Ignore with Belma Alispahic Connect with Yossi Quint: LinkedIn: https://www.linkedin.com/in/yossi-quint Ark: https://www.ark-biotech.com Next step: Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them) 13:28

18 weeks ago13:28

13:28

Sickle cell disease affects thousands with severe daily pain. While FDA-approved gene therapies exist, their $2.2 million cost per treatment makes them largely inaccessible. In this episode of the Smart Biotech Scientist Podcast, David Brühlmann explores five key challenges facing the bioprocessing industry in making these therapies more accessible: Moving Away from Platform Technologies Traditional bioprocessing relies on platform technologies for antibody production. However, new therapies require more flexible, adaptable systems that can accommodate novel modalities. Increased Personalization and Smaller Batch Sizes Personalized medicine, especially autologous cell therapy, demands highly customized approaches. With batch sizes of one patient, traditional automation becomes challenging, requiring new methodologies. Cultivating Sensitive Cells Modern cell types need gentler handling than traditional CHO cells. Companies are developing innovative bioreactor technologies, from acoustic wave systems to stress-free cultivation methods. The Cell as the Product Cell-based products are billion times more complex than antibodies, requiring sophisticated production, monitoring, and quality control processes. Accessibility and Cost Challenges High treatment costs remain the biggest barrier. For example, only 21,000 of 900,000 eligible patients have received CAR T cell therapy due to financial constraints. Moving Forward Industry leaders across academia and pharma are collaborating to overcome these challenges through innovation and cost reduction. Every improvement brings us closer to making these treatments accessible to more patients. Join us on the Smart Biotech Scientist Podcast as we explore innovative solutions to these challenges. Next step: Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
135: Beyond Breakthroughs: Making Biotherapeutics Affordable for All 12:46

18 weeks ago12:46

12:46

In a world of rapid advancements in medical science and biotechnology, bioprocessing is at the forefront of healthcare innovation. Yet, despite remarkable progress, life-saving biotherapeutics remain out of reach for much of the global population. A staggering 80% of patients worldwide lack access to the biotherapeutics they need. While bioprocessing has made impressive strides, the high cost and slow development of these treatments create significant barriers. Addressing these challenges is critical to making innovative therapies widely available. David Brühlmann is launching a special four-part series based on his keynote at the Amphacademy, exploring bioprocessing’s revolutionary journey - from the early days of recombinant insulin to today’s groundbreaking therapies. This series will also highlight strategies to make these innovations more accessible to patients worldwide. From Standardization to Personalization One major challenge is the shift away from platform technologies. Traditionally, antibodies were produced using standardized CHO cell templates and purification steps, but this approach falls short for new modalities. Personalized therapies further complicate the landscape. Autologous cell therapies, for example, require isolating, cultivating, and reinfusing a patient’s own cells. These small-batch processes are labor-intensive, less automated, and often reliant on outdated, paper-driven workflows. Innovations in Bioreactor Design With the rise of sensitive cell therapies, bioreactor design must evolve. Unlike CHO cells, these delicate cells require gentler handling environments. Innovations like acoustic wave bioreactors, bionic bioreactors, and specialized cell screws are emerging to optimize cell growth and improve efficiency. The Complexity and Cost of Cell-Based Products New bioprocessing modalities bring greater complexity. Cell-based therapies and cultivated meats are far more intricate than traditional antibody proteins, making scaling production and ensuring quality especially challenging. High production costs further limit access. Even in regions where these therapies are approved, pricing remains a major barrier. Lowering manufacturing costs is essential to democratizing these life-saving treatments. The shift from basic recombinant proteins to complex cell-based therapeutics is just the beginning. Overcoming these challenges - scaling production, reducing costs, and managing complexity - is key to making breakthrough therapies accessible to all. Next step: Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment Develop bioprocessing technologies better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
134: Seamless Seed Trains: Simplify Without Sacrificing Quality with François Carruzzo - Part 2 16:53

19 weeks ago16:53

16:53

The biotechnology industry is on a transformative path. With emerging technologies and innovative ideas, bioprocessing professionals are poised to revolutionize how therapies are developed and delivered. In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann continues his conversation with François Carruzzo, the CTO of Bioscibex, as they delve into the challenges and opportunities present in the biotech landscape. Bioprocess automation boosts efficiency and scalability in therapeutic production. François Carruzzo explores how automation and sensors simplify processes, cut costs, and enhance reliability - key to making biologics more accessible worldwide. Here are some key lessons Carruzzo learned on his entrepreneurial journey: Seeking and Leveraging Advice as a Startup: For biotechnology entrepreneurs, seeking the right advice is a cornerstone for success. Carruzzo discusses the significance of having a scientific advisor. He highlights the value of external perspectives in helping startups navigate strategic decisions, addressing complex challenges, and innovating effectively. The Role of Networking and Ecosystems: Startup ecosystems and networks play an indispensable role in propelling innovations within the biotech industry. Situated in Lausanne, Switzerland, Bioscibex is well-positioned within a dynamic biopharma ecosystem. Utilizing incubators and networking events, Carruzzo underscores the importance of connecting with other innovative organizations and experts, which can accelerate product development and industry relevance. Customer Engagement as a Key Driver for Innovation: Understanding and integrating the voice of the customer is pivotal in product development. Carruzzo emphasizes starting customer interactions early in the development process. Engaging with potential users before launching a prototype allows companies to tailor products that meet user needs and align with market demands. Carruzzo advises biotech entrepreneurs to validate their ideas through market research and pursue them with commitment. He highlights the challenges of innovation but emphasizes its invaluable rewards. By streamlining processes and prioritizing innovation, the biotech industry can drive progress that benefits both companies and patients worldwide. This episode highlights how breakthrough biotech innovations require strategy, regulatory expertise, and customer focus. Bioscibex’s journey exemplifies technology’s transformative power in the industry. Want to dive deeper into the startup journey and gain insights from entrepreneurs? Episodes 119-120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian Guo Episodes 107-108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David Schönauer Episodes 83-84: The Hidden Potential of Shake Flasks: What Every Biotech Scientist Needs to Know with Jens Bayer Episodes 81-82: Regenerating Muscles: The Future of Autologous Cell-based Therapy with Deana Mohr Connect with François Carruzzo: LinkedIn: https://www.linkedin.com/in/francois-carruzzo Bioscibex: https://bioscibex.com Next step: Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment Develop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
133: Seamless Seed Trains: Simplify Without Sacrificing Quality with François Carruzzo - Part 1 22:30

19 weeks ago22:30

22:30

Biologics manufacturing relies heavily on optimizing various stages, yet the seed train step - often overlooked - plays a critical role in determining overall efficiency. The seed train involves expanding cells from a small working cell bank to scales suitable for production bioreactors. Francois Carruzzo, Co-founder and CTO of Bioscibex, is rethinking how this process can be simplified, streamlined, and made more reliable, using a fully automated, closed system. However, the complexity of scaling introduces several risks, including handling errors, contamination, and delays that could derail production timelines. Today, seed train processes involve multiple vessels, open handling, and labor-intensive steps, all of which complicate operations. François identified two prominent challenges: Contamination Risks: Multiple open steps, such as using spin tubes, shake flasks, and wave systems, result in a heightened potential for contamination. Operational Complexity: With multiple campaigns and products running simultaneously, accommodating different media types and containers can become overwhelming. Bioscibex is on the verge of revolutionizing seed train operations with its innovative single-use bioreactor system. François shared how this system addresses traditional shortcomings: Wide Turndown Ratio: Capable of scaling from 30 mL all the way to 30 L within the same vessel, Bioscibex's rocking motion reactor eliminates multiple intermediary steps. Closed Workflow: By maintaining a fully enclosed environment, the system dramatically lowers contamination risks, making bioprocessing more reliable. Continuous Cell Expansion: Unlike traditional methods that involve batch dilutions, Bioscibex supports continuous cell expansion, ensuring optimal growth conditions with reduced downtime. Innovation in seed train processes extends far beyond mere operational efficiency. It lays the groundwork for scalable, consistent biologics production, ensuring therapies can reliably reach clinics faster. By simplifying the mundane yet critical seed train step, his innovation offers a glimpse into the future of stress-free, scalable cell expansion - a vision we’re excited to see unfold. Interested in finding out more about the progress made in cell culture? Take a listen to what our previous guests had to say about it: Episodes 117-118 - Critical Bottlenecks and Breakthroughs in Cell Line Development with Andrea Gough Episodes 113-114: Weighing of Single-Use Bag Systems: Why Traditional Load Cells Are Holding You Back with Anders Tvegaard Episodes 109-110: Spinning Like Earth: Designing Low-Shear Bioreactors for Better Cell Culture with Olivier Detournay Connect with François Carruzzo: LinkedIn: https://www.linkedin.com/in/francois-carruzzo Bioscibex: https://bioscibex.com Next step: Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment Develop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
132: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza Farahani - Part 2 14:57

20 weeks ago14:57

14:57

Artificial Intelligence (AI) is transforming industries worldwide, and biotechnology is no exception. In bioprocess development, AI is proving to be a game-changer, accelerating workflows, optimizing processes, and driving innovation. On the Smart Biotech Scientist Podcast , Reza Farahani, founder and CEO of Catalyze AI, shares his insights on how AI is reshaping biomanufacturing and the future of the industry. As AI continues to integrate into bioprocessing, the role of scientists is evolving. Farahani envisions a future where scientists collaborate with AI to enhance efficiency. One of Catalyze AI’s exciting innovations is an agentic root cause analysis tool, designed to automate troubleshooting. Instead of spending hours on manual analysis, scientists will receive AI-generated reports outlining probable causes of failures—allowing them to focus on high-level decision-making. What you’ll learn in this episode: Exciting Advances in AI : Farahani highlights the potential of Artificial General Intelligence (AGI)—AI that can generate ideas through analogy, much like humans do. Imagine an AI system recognizing a successful method in the petroleum industry and applying those principles to biomanufacturing. This kind of cross-disciplinary innovation could unlock groundbreaking efficiencies. Leadership Principles in AI-Driven Biotech Startups: Farahani takes an unconventional approach to leadership. Unlike corporate environments where avoiding mistakes is crucial, he encourages his team to embrace failure early on. "I want to see you make a mistake in the first month," he tells new hires. By removing the fear of failure, his team can experiment, think creatively, and drive true innovation—an essential mindset for biotech startups breaking new ground. Advice for Aspiring Biotech Entrepreneurs: Farahani’s advice is simple: find a problem, develop a unique solution, and take action. He urges scientists to identify small inefficiencies that can be scaled and optimized. Equally important is being open to failure and iterating quickly to refine solutions. Success comes from starting, adapting, and continuously improving. As we stand on the brink of a biomanufacturing revolution, the real opportunity lies in combining AI with biologics. While AI often dominates the conversation, Farahani emphasizes that biologics remain underhyped. The true breakthroughs will come from leveraging AI to solve real-world challenges in biomanufacturing, leading to significant efficiencies and industry-wide advancements. For those passionate about this field, staying connected with thought leaders like Reza Farahani and keeping up with the latest innovations is key. As AI and biologics continue to converge, the future of bioprocessing holds unprecedented potential for transformation and progress. Curious about how AI is transforming bioprocessing? Discover how industry experts are driving innovation to shape the future of this field. Episodes 111 and 112: AI Meets Biology: Why Domain Expertise Still Rules in the Age of Large Language Models with Lars Brandén Episodes 107 and 108: From 1 Billion to 100: How AI is Cracking the Enzyme Discovery Code with David Schönauer Connect with Reza Farahani LinkedIn: https://www.linkedin.com/in/reza-farahani-/ Catalyze AI: https://www.catalyzeai.com/ Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment Develop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
131: Combining AI and Biomanufacturing for Sustainable, Cost-Effective Therapeutics with Reza Farahani - Part 1 26:55

20 weeks ago26:55

26:55

The real-world applications of AI in biomanufacturing are transformative. From reducing drug development timelines to optimizing production yields, AI is making biomanufacturing more efficient and cost-effective. This, in turn, enhances global access to life-saving therapies. As AI continues to evolve, its potential to drive even greater innovations in biologics manufacturing becomes increasingly promising. In the latest episode of the Smart Biotech Scientist Podcast , David Brühlmann speaks with Reza Farahani, founder and CEO of Catalyze AI, about the profound impact of AI on biomanufacturing. They discuss how AI is reshaping drug development, reducing costs, and simplifying complex biomanufacturing processes - bringing us closer to a future where life-saving drugs are as accessible as smartphones. Why You Should Tune In: AI’s Role in Democratizing Biomanufacturing : One of the core missions of Catalyze AI is to democratize the sophisticated knowledge that currently resides mostly within top pharmaceutical companies. By leveraging AI to improve bioprocess development, Farahani aims to bridge the knowledge gap between academia and industry, thereby reducing the cost and accelerating the development of new therapeutics. This democratization of bioprocess knowledge could potentially revolutionize the accessibility and affordability of life-saving drugs. How AI Optimizes Bioprocess Development: AI has the unique ability to manage and analyze complex, convoluted data sets much more efficiently than humans. Reza explains how transformer models—similar to the ones used in natural language processing tasks by ChatGPT—can be utilized to predict and optimize various steps in the biomanufacturing process. These models can learn and make predictions based on past data, enabling a significant reduction in the time and resources required for process development. Solving the Scale-Up Challenge: Scale-up remains one of the most challenging aspects of bioprocess development, often plagued by delays and inefficiencies. AI can immensely help by leveraging data from both small and large-scale biomanufacturing processes to predict optimal conditions. However, given the complexity and high cost associated with scale-up experiments, Reza envisions a future where distributed, small-scale biomanufacturing units could replace large-scale facilities. This would not only reduce costs but also enhance flexibility and resilience against process failures. AI is not just accelerating drug development—it’s reshaping the entire biomanufacturing landscape. Don’t miss this insightful conversation on how AI is driving the future of biotech. As we stand at the intersection of AI and biomanufacturing, the possibilities are limitless. With continued advancements, we may soon witness a paradigm shift where drug production becomes more decentralized, efficient, and tailored to global healthcare needs. The future of biotech is being written now—are you ready to be part of it? Interested in exploring more about AI’s impact on bioprocessing? Check out what other experts in the field are doing to drive innovation in this space. Episodes 119 and 120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian Guo Episodes 115 and 116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy Agresti Connect with Reza Farahani LinkedIn: https://www.linkedin.com/in/reza-farahani-/ Catalyze AI: https://www.catalyzeai.com/ Wondering how to develop biomanufacturing processes with peace of mind? Schedule your free assessment to propel your success: Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
130: Revolutionizing Cell Therapy Manufacturing: Reducing Costs to Reach More Patients with Jason Foster - Part 2 20:15

21 weeks ago20:15

20:15

The intricacies of tech transfer and the challenges of scaling manufacturing processes are often underestimated in the biotechnology industry. Understanding these complexities is crucial for translating innovative scientific breakthroughs into commercially viable products. In the second part of the conversation with Jason Foster, CEO of Ori Biotech, host David Brühlmann explores the complexities of cell therapy manufacturing. Their discussion highlights key challenges, including tech transfer, scale-out strategies, and the crucial role of commercial strategy alongside scientific excellence. Jason also revealed a groundbreaking approach in the cell therapy space. He detailed how Ori's IRO® platform can process multiple patient doses simultaneously, enabling treatment for 30 patients in parallel within just 1,000 square feet of clean room space. This innovative method drastically reduces clean room requirements by about 95% and facility sizes by approximately 50%, significantly cutting costs associated with building and operating large-scale facilities. As Jason emphasized, this shift not only accelerates access to groundbreaking therapies but also provides a sustainable model for scaling cell therapy production. Key Points to Remember: Integrated Approach: Scientists should look beyond their specialized areas and understand the requirements of subsequent bioprocessing stages to maximize patient impact. Technological Evolution: Advancing distributed manufacturing and enhancing in-line analytics are essential steps to revolutionize the biotech landscape. Commercial Viability : Prioritizing commercial feasibility alongside safety and efficacy in preclinical development can prevent costly late-stage setbacks. This episode of the Smart Biotech Scientist underscores the complexities and transformative potential of cell therapy manufacturing. As the industry continues to innovate, integrating commercial viability, flexibility, and advanced manufacturing solutions will be critical. By breaking down silos and fostering collaboration, we can accelerate the development of life-saving therapies—ensuring they reach patients faster and more efficiently. Connect with Jason Foster LinkedIn: https://www.linkedin.com/in/jasoncfoster Oribiotech: https://oribiotech.com Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment Develop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
129: Revolutionizing Cell Therapy Manufacturing: Reducing Costs to Reach More Patients with Jason Foster - Part 1 22:10

21 weeks ago22:10

22:10

One of the most urgent challenges in modern medicine is making cell and gene therapies widely accessible. These therapies, while groundbreaking in their safety and efficacy, often fall short when it comes to reaching patients. The reasons are manifold—high manufacturing costs, logistical complexities, and inefficiencies in the production pipeline. We're joined by Jason Foster, CEO and Executive Director of Ori Biotech, a company that's revolutionizing cell and gene therapy manufacturing through automation and innovative approaches. Jason sheds light on the technical bottlenecks that limit patient access to life-saving therapies and discusses how an integrated, holistic view of the development chain could make a significant difference. From the complexities of centralized manufacturing and the interconnectedness of the supply chain, to specific technical solutions Ori Biotech has developed, we explore the multi-faceted issues and potential solutions in making these advanced therapies more reachable. Here are three key takeaways from our conversation: Holistic Development Chain : Jason emphasizes the importance of integrating all stakeholders in the development chain, ensuring everyone understands what happens before and what needs to happen next to improve the overall process. Technical Bottlenecks & Solutions : We delved into various technical bottlenecks, including centralized manufacturing and logistical complexities. Jason highlighted how Ori Biotech is addressing these issues through automation and reducing manual labor, which can cut manufacturing costs by 50%. Impact on Accessibility : It's alarming that only 3-5% of patients who need CAR-T therapies have access to them. Jason's mission with Ori Biotech is to transform this narrative by enabling widespread access to these life-saving therapies through innovative manufacturing solutions. As cell and gene therapies stand poised to revolutionize cancer and rare disease treatment, the focus must shift toward overcoming manufacturing constraints. By integrating automation and aiming for decentralized models, companies like Ori Biotech offer a glimpse into a future where these revolutionary treatments are accessible to all who need them. Fascinated by Cell Therapy? Hear from top experts in these two episodes! Episodes 11 and 12: From Lab to Patient: Steve Oh’s Guide to Mastering Cell Therapy Process Development Episodes 21 and 22: Unleashing Effective QbD Strategies to Master Cell Therapy with Shin Kawamata Connect with Jason Foster LinkedIn: https://www.linkedin.com/in/jasoncfoster Oribiotech: https://oribiotech.com Wondering how to develop cell and gene therapies with peace of mind? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment Develop biotherapeutics better, faster, at a fraction of the cost with our 1:1 Strategy Call. Book your call at https://stan.store/SmartBiotech/p/book-a-11-call-with-me-j4vhuo6t Support the show…

Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation

1
128: The 7 Hidden Innovation Habits That Top Biotech Scientists Use Daily - Part 2 17:42

22 weeks ago17:42