A myriad of AI, science, and technology experts explore the real challenges and enormous opportunities facing entrepreneurs who are building the future of health. Raising Health, a podcast by a16z Bio + Health and hosted by Kris Tatiossian and Olivia Webb, dives deep into the heart of biotechnology and healthcare innovation. Join veteran company builders, operators, and investors Vijay Pande, Julie Yoo, Vineeta Agarwala, and Jorge Conde, along with distinguished guests like Mark Cuban, Greg ...
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149: How to Leverage AI in Media Development Without Sacrificing Process Understanding with Tom Fletcher - Part 1
Manage episode 479683788 series 3525243
Content provided by David Brühlmann - CMC Development Leader, Biotech C-level Advisor, Business Strategist, David Brühlmann - CMC Development Leader, Biotech C-level Advisor, and Business Strategist. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by David Brühlmann - CMC Development Leader, Biotech C-level Advisor, Business Strategist, David Brühlmann - CMC Development Leader, Biotech C-level Advisor, and Business Strategist or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
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
157 episodes
ShareManage episode 479683788 series 3525243
Content provided by David Brühlmann - CMC Development Leader, Biotech C-level Advisor, Business Strategist, David Brühlmann - CMC Development Leader, Biotech C-level Advisor, and Business Strategist. All podcast content including episodes, graphics, and podcast descriptions are uploaded and provided directly by David Brühlmann - CMC Development Leader, Biotech C-level Advisor, Business Strategist, David Brühlmann - CMC Development Leader, Biotech C-level Advisor, and Business Strategist or their podcast platform partner. If you believe someone is using your copyrighted work without your permission, you can follow the process outlined here https://ppacc.player.fm/legal.
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
157 episodes
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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.…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
S
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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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.…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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-j4vhu…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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.…
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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
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Play Later Play Later Lists Like LikedSend us a text 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:…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text 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…
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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
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Play Later Play Later Lists Like LikedSend us a text The world of bioprocess development in biotechnology is evolving at an unprecedented pace, driven by the quest for breakthrough innovations. While new technologies play a significant role, what truly sets successful innovators apart are fundamental habits that foster an environment ripe for groundbreaking discoveries. In today's discussion, we'll delve into three essential habits that, when combined with the four habits previously discussed, can redefine your approach to bioprocess development. Additionally, we'll wrap up with a bonus tip that has the potential to revolutionize your career. Challenge the Status Quo - In any scientific endeavor, particularly in biotech, a common pitfall is accepting established processes as the best or only methods. The fifth habit to cultivate is the continuous challenging of the status quo. When was the last time you scrutinized your standard operating procedures and wondered why they are the way they are? Embrace Continuous Learning - Innovation in biotech is characterized by rapid advancements, and staying ahead demands continuous learning. According to a 2023 EDX survey, nearly half of today's workplace skills will be obsolete by 2025, primarily due to AI advancements. Hence, the sixth habit is to never stop learning. Harness the Power of Passion - At the core of every great innovation is passion. The seventh habit revolves around the deep sense of purpose that drives scientific pursuits. Beyond the routine aspects of bioprocess development, what truly fuels your ambition? Finally, a game-changing career strategy known as Strategic Cross-Pollination Networking can significantly enhance your innovative capabilities. This goes beyond traditional networking, focusing on building connections across various domains to foster innovative solutions. Innovation in bioprocess development is not about daily eureka moments but about the consistent application of these habits. Small, persistent efforts can cumulatively lead to transformative results in this rapidly evolving field. If you found these insights valuable, share them with your colleagues. Ready to fast-track your product and technology development? As a strategic advisor to biotech leaders, we can help you eliminate costly delays and optimize your path to market. 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…
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Smart Biotech Scientist | Master Bioprocess CMC Development, Biologics Manufacturing & Scale-up, Cell Culture Innovation
1 127: The 7 Hidden Innovation Habits That Top Biotech Scientists Use Daily - Part 1 15:53
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Play Later Play Later Lists Like LikedSend us a text In the fast-paced and highly regulated world of biotech development, maintaining an innovative spirit can sometimes feel like a Herculean task. Between optimizing cell culture processes and navigating strict regulatory requirements, it’s no wonder many scientists feel the weight of daily operations pressing down on their creativity. However, fostering innovation is crucial for breakthroughs in our field. David Brühlmann shares practices that have transformed how scientists approach complex challenges in our field. Here are the first four habits that can reshape your approach to bioprocess development. Cultivate Deep Curiosity : Curiosity is the cornerstone of scientific discovery. However, it’s not just about a broad interest in science. The type of curiosity that drives innovation is the kind that goes beyond initial observations. It's the kind that makes you question what's happening inside the cell culture and strive to understand phenomena at a fundamental level. Connect the Dots : Innovation often comes from connecting seemingly unrelated ideas. Drawing connections between different facts or events can lead to a better understanding and new approaches to complex challenges. Embrace Calculated Risks: In a GMP environment, risk-taking may sound contradictory. However, calculated risks are essential for innovation. It's about carefully evaluating opportunities and understanding their potential impact before acting. Practice Persistence: Persistence is a key ingredient for innovation, especially during challenging times. Experimentation often involves setbacks and unexpected results, but each failure is a learning opportunity. Fostering innovation in biotech development is a multifaceted process that requires curiosity, the ability to connect dots, calculated risks, persistence, collaboration, digital tools, and continuous learning. By integrating these habits into your work routine, you can unlock new potentials and drive breakthroughs in the biotech field. Remember, breakthroughs often come from embracing the complex nature of bioprocess development and continuously exploring, questioning, and innovating. Don't miss our next episode, where we’ll reveal the final three habits! 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…
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