Send us a text In this riveting episode of the Smart Biotech Scientist podcast, we navigate the intricate labyrinth of biotech scale-ups. We distill the process down to 9 essential steps for a smooth transition from laboratory to large-scale production. Key Insights: Acquire Comprehensive Process Understanding: Bolster your decision-making and problem-solving skills with an in-depth understanding of your process, molecule, and expertise at your disposal. Span the Technology Gaps: Tackle obstacle...
Feb 08, 2024•13 min•Ep 26•Transcript available on Metacast Send us a text In this enlightening episode of the Smart Biotech Scientist podcast, we delve into the complex world of biotech scale-ups. We break down the 9 crucial steps to ensure a seamless transition from lab to large-scale production. Top 3 Takeaways: Gain Comprehensive Process Understanding: Enhance your decision-making and problem-solving abilities by thoroughly understanding your process, molecule, and available expertise. Bridge the Technology Gaps: Overcome challenges and increase effi...
Feb 06, 2024•19 min•Transcript available on Metacast Send us a text If you've ever wondered how to seamlessly transition from R&D to process development, this is your golden ticket. Uncover practical strategies and expert advice that can be your compass through the intricate landscape of mastering CMC development. Uncover the challenges and tactics to seamlessly navigate this critical phase. Conduct Early Developability Assessments: By assessing productivity, aggregation propensity, and manufacturability early on, you can strategically av...
Feb 01, 2024•23 min•Transcript available on Metacast Send us a text Embark on a journey into the intricate world of CMC development with our latest episode, unraveling the challenges that often baffle biotech scientists. The complexity of CMC development is a formidable hurdle, and in this insightful discussion, we delve into strategies to master this critical process. Key Takeaways: Start Early: Learn how starting CMC development early, even without a complete understanding of your drug, can reduce risks and prepare you better for clinical milest...
Jan 30, 2024•18 min•Ep 23•Transcript available on Metacast Send us a text Are you looking for advanced strategies to enhance the quality and efficiency of cell therapy manufacturing processes? In this episode with Shin Kawamata, CEO of Cyto-Facto Inc., we dive into the transformative power of digitization in cell therapy manufacturing and explore strategies to enhance efficiency and reduce costs. Actionable Takeaways: Initiate Digital Transformation: Take the first step toward transforming your manufacturing processes by incorporating robust data busine...
Jan 25, 2024•19 min•Ep 22•Transcript available on Metacast Send us a text Are the escalating costs and intricate technical hurdles of cell therapy development causing you stress? Tune into this insightful podcast episode featuring Shin Kawamata, CEO of Cyto-Facto Inc. in Kobe, Japan, who shares his expertise and innovative solutions to these pressing issues in the cell therapy industry. Discover how to streamline your manufacturing processes, reduce costs, and enhance product quality, transforming the way you approach cell therapy development. Key Takea...
Jan 23, 2024•22 min•Transcript available on Metacast Send us a text Welcome to Part 2 of our conversation with Bernardo Estupiñán Gaisbauer, Principal at Drug Biologics Consulting. In this insightful episode, we dive into the complex world of taking a molecule from the lab to clinical trials. Our guest shares invaluable insights into outsourcing strategies for biotech companies. Key Learnings: Strategic Outsourcing: Discover when and why outsourcing is crucial for biotech companies, particularly in areas like analytical work and process developmen...
Jan 18, 2024•17 min•Transcript available on Metacast Send us a text Are you ready to unlock the secrets of taking your molecule from the lab to clinical trials? Join us in an exclusive interview with Bernardo Estupiñán Gaisbauer, a seasoned expert and principal at Drug Biologics Consulting, as he reveals the crucial steps and strategies necessary for a successful journey in CMC development. Biotech scientists often underestimate the challenges of transitioning a molecule from the lab into large-scale production. Bernardo emphasizes the critical im...
Jan 16, 2024•20 min•Transcript available on Metacast Send us a text In part 2 of this interview with Ioscani, Assistant Professor at the School of Chemical & Bioprocess Engineering, University College Dublin, we delve into the art and science of accelerating process development through the strategic extraction of valuable insights from data. Our guest, a seasoned expert in computational modeling, unfolds the intricate dance between quality by design principles and data-driven approaches. Key takeaways from this insightful conversation include:...
Jan 11, 2024•14 min•Transcript available on Metacast Send us a text Join us as we unravel the complexities of computational methods in bioprocessing, featuring cutting-edge research on glycosylation and process development. Ioscani Jiménez del Val, Assistant Professor at the School of Chemical & Bioprocess Engineering, University College Dublin, explores the intricacies of creating computational models, closing the loop, and optimizing with numerical methods. Discover the two broad flavors of modeling – kinetic and metabolic models – and how t...
Jan 09, 2024•19 min•Ep 17•Transcript available on Metacast Send us a text In part 2, we explore the details of cost reduction in cultivated meat manufacturing, with a focus on two important factors: media and simplified bioreactors. Beat Thalmann, a passionate innovator and serial entrepreneur specializing in the development of animal-free cell culture systems, highlights the strategic importance of selecting the right cells and advocates for a streamlined process that incorporates plant-based structures. This approach offers a cost-effective entry poin...
Dec 21, 2023•20 min•Ep 16•Transcript available on Metacast Send us a text Is bacon without pigs the future? In this episode, join us as Beat Thalmann, a passionate innovator and serial entrepreneur specializing in the development of animal-free cell culture systems, unveils the exciting possibilities. Discover how he overcomes the challenges of production and envisions a future where cultivated steak competes on price. Beat Thalmann provides an insider's perspective on the complexities of cell lines and production processes, exploring the intersect...
Dec 19, 2023•18 min•Transcript available on Metacast Send us a text Are you struggling to unlock the full potential of Process Analytical Technology (PAT) in biomanufacturing? Look no further! Join us for a game-changing conversation with Abhijeet Satwekar, an Innovation Manager at Merck Guidonia-Rome, Italy. Discover how PAT can revolutionize your decision-making, accelerate development timelines, and propel your biotech company to new heights. Key Learnings: Decoding PAT's Impact: Abhijeet provides unprecedented insights into how PAT techno...
Dec 14, 2023•17 min•Transcript available on Metacast Send us a text Wondering how you can leverage the immense potential of the rapidly evolving world of digital transformation in biomanufacturing? Join us as we explore the frontiers of technology and innovation with Abhijeet Satwekar, Innovation Manager at Merck Healthcare. Discover how cutting-edge digital technologies are revolutionizing bioprocesses, optimizing efficiency, and ensuring consistent product quality. Key Learnings: Process Optimization: Discover the transformative impact of digita...
Dec 12, 2023•17 min•Ep 13•Transcript available on Metacast Send us a text Welcome back to the second part of our exclusive interview with Steve Oh, former Institute Professor at the Bioprocessing Technology Institute (BTI) at the Agency for Science and Technology (A*STAR) and now Scientific Advisor to several international companies. In this episode, Steve dives deep into the challenges of manufacturing different cell types, sharing insights gained from his groundbreaking research. From preventing spontaneous differentiation to optimizing multi-stage pr...
Dec 07, 2023•17 min•Transcript available on Metacast Send us a text Dive into the world of cell therapy process development with Steve Oh, former Institute Professor at the Bioprocessing Technology Institute (BTI) at the Agency for Science and Technology (A*STAR) and now Scientific Advisor to several international companies, as he shares thought-provoking perspectives and predictions on technologies that will impact the biotech industry. In this riveting conversation, Steve Oh unveils secrets to consistent bioproducts and forecasts the future of c...
Dec 05, 2023•25 min•Transcript available on Metacast Send us a text Unlock the secrets of cell-line development with Tanner Nevill, the SVP of Applications at Bruker Cellular Analysis and one of the primary inventors and developers of the Beacon Optofluidic Platform. In this interview, Tanner delves into the transformative power of nanopens and microenvironments in cell-line development. Key Takeaways: Nanopens Redefining Norms: Tanner introduces the game-changing nanopens, disrupting traditional cell line development. Learn how these innovative t...
Nov 30, 2023•16 min•Transcript available on Metacast Send us a text In this episode, Tanner Nevill, the SVP of Applications at Bruker Cellular Analysis and one of the primary inventors and developers of the Beacon Optofluidic Platform, shares insights into revolutionizing cell-line development through nanopens and microenvironments. Key Takeaways: Challenging the Status Quo: Tanner challenges conventional thinking, highlighting the limitations of planar cell cultures and the shortcomings of traditional approaches in the field. His perspective spar...
Nov 28, 2023•14 min•Transcript available on Metacast Send us a text In the second part of our insightful interview with Payar Radfar, CEO of Smart MCs, we delve into the practical steps of developing adherence cell cultures for bioprocessing scalability. Payar emphasizes the critical need for patience and a methodical approach, recounting how many clients rush into large-scale cultures prematurely. The key takeaways include: 1. Start Small, Stay Patient: Begin with small cultures and test various microcarriers. Patience is crucial; rushing can lea...
Nov 23, 2023•13 min•Ep 8•Transcript available on Metacast Send us a text In this episode, we explore the world of adherent cell cultures with Payar Radfar, CEO of Smart MCs. Smart MCs specializes in customized biomaterials and microfluidic solutions. Payar shares his unique journey in the biotech industry, driven by his passion for improving people's health. Key Takeaways: 1. Revolutionizing Bioprocessing: Payar discusses the challenges scientists face when transitioning from lab-scale to industrial-scale production. He emphasizes the importance o...
Nov 21, 2023•16 min•Transcript available on Metacast Send us a text In the second part of our conversation with Michael Sokolov, the co-founder and COO of DataHow, we dive into practical insights on leveraging hybrid modeling in bioprocessing. You will discover: 1. Starting Small, Dreaming Big: Even in smaller companies, you can start with a minimal number of reactors and still leverage hybrid modeling effectively. Whether it's just a few shakers or a handful of bioreactors, you can begin the journey to process improvement. 2. The Power of Di...
Nov 16, 2023•19 min•Transcript available on Metacast Send us a text In this insightful conversation, we explore how to accelerate bioprocess development and enhance manufacturing using hybrid modeling. Our guest, Michael Sokolov, COO of DataHow (a spin-off company from ETH Zurich), shares valuable insights. Discover the three major takeaways that could transform the bioprocessing industry: 1. Unlocking the Power of Hybrid Modeling : Michael Sokolov introduces the revolutionary concept of hybrid modeling, which combines mechanistic knowledge with m...
Nov 14, 2023•17 min•Transcript available on Metacast Send us a text In today's episode, we continue our fascinating conversation with Leonardo Sibilio, CEO of Biotech Academy and CSO at BetaPro Consulting. We delve into the pivotal role of structured training in the dynamic biotech industry. In this episode, you'll discover: - Foundation of Success : Leonardo emphasizes the importance of a strong foundation in GMP and an understanding of biotech facility operations. Whether you're an aspiring employee or a seasoned professional, a s...
Nov 09, 2023•13 min•Transcript available on Metacast Send us a text In this captivating episode, we delve into the world of biotech scale-up with the seasoned expert, Leonardo Sibilio, CSO at BetaPro Consulting and CEO of the Biotech Academy in Rome. Discover how mastering the art of biotech scale-up can transform your journey from doubt to dominance. Key Takeaways: 1. Early Planning is Paramount: Leonardo emphasizes the importance of initiating the scale-up process as early as possible. Waiting until later phases can lead to challenges and hinder...
Nov 07, 2023•17 min•Transcript available on Metacast Send us a text Welcome to a fascinating Smart Biotech Scientist episode! In this conversation, we dive deep into the nuts and bolts of rational media development with our guest, Tom Fletcher, R&D Director, Process development, Fujifilm Irvine Scientific. Together, we explore the immense potential of Rational Media Design and how it's transforming the industry. Here are three major takeaways from this episode: 1. Define Your Goals: Tom emphasizes the importance of clearly defining your b...
Nov 07, 2023•16 min•Transcript available on Metacast Send us a text In this episode with Tom Fletcher, R&D Director, Process development, Fujifilm Irvine Scientific, we delve into the world of bioprocessing. Tom shares insights into the transformative power of rational media design. From the complexities of bioprocess development to the game-changing potential of AI, this interview is a treasure trove of knowledge for both scientists and engineers. You will learn: - Learn about the evolution of priorities during bioprocess development, from sp...
Nov 07, 2023•18 min•Transcript available on Metacast Send us a text Are you a busy biotech scientist, trying to navigate the complex world of bioprocessing while fueling your passion for science? Join us on the Smart Biotech Scientist Podcast, where we're about to unravel the secrets to bioprocess mastery. Hosted by a seasoned biotech leader and entrepreneur with over 15 years in the industry, this podcast is your compass through the maze of challenges. Picture yourself in the lab, deadlines looming, feeling like you're solving a puzzle ...
Oct 31, 2023•3 min•Transcript available on Metacast 
