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PODCAST

Smart Biotech Scientist | The CMC and Biomanufacturing Podcast for Bioprocess Development and Manufacturing Leaders

David Brühlmann - CMC Development Leader, Bioprocess Expert, Business Strategist

The go-to CMC and bioprocessing podcast for process development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error.Practical, execution-focused guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics.Hosted by Dr. David Brühlmann, CMC strategist, former Bioprocess Innovation Manager at Merck, PhD in glycoengineering, and close to 20 years of biomanufacturing experience. Smart Biotech

science life sciences

All Episodes

25:15

141: How Microalgae Cuts Antibody Costs by 70% and...

Smart Biotech Scientist | The CMC and... ·

2025/04/01

Send 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...

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20:42

140: Regulatory Secrets Revealed: Why Your CMC...

Smart Biotech Scientist | The CMC and... ·

2025/03/27

Send 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 a...

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25:21

139: Regulatory Secrets Revealed: Why Your CMC...

Smart Biotech Scientist | The CMC and... ·

2025/03/25

Send 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 insigh...

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20:16

138: Skip 90% of Bioreactor Runs: The In Silico...

Smart Biotech Scientist | The CMC and... ·

2025/03/20

Send 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 revolut...

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21:55

137: Skip 90% of Bioreactor Runs: The In Silico...

Smart Biotech Scientist | The CMC and... ·

2025/03/18

Send 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 experime...

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13:28

136: 5 Roadblocks to Affordable Biologics (And How to...

Smart Biotech Scientist | The CMC and... ·

2025/03/13

Send us a text Sickle cell disease, a genetic disorder affecting thousands, presents a daily struggle akin to having shards of glass tearing through one's veins. Despite breakthrough gene therapies approved by the FDA, the prohibitive cost of $2.2 million per treatment limits their accessibility. In the latest episode of the Smart Biotech Scientist Podcast, host David Brühlmann discusses five critical challenges the bioprocessing industry must overcome to make these life-saving therapies acce...

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12:46

135: Beyond Breakthroughs: Making Biotherapeutics...

Smart Biotech Scientist | The CMC and... ·

2025/03/11

Send 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...

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16:53

134: Seamless Seed Trains: Simplify Without...

Smart Biotech Scientist | The CMC and... ·

2025/03/06

Send 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 an...

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22:30

133: Seamless Seed Trains: Simplify Without...

Smart Biotech Scientist | The CMC and... ·

2025/03/04

Send 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 c...

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14:57

132: Combining AI and Biomanufacturing for...

Smart Biotech Scientist | The CMC and... ·

2025/02/27

Send 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 scienti...

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26:55

131: Combining AI and Biomanufacturing for...

Smart Biotech Scientist | The CMC and... ·

2025/02/25

Send 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 Brü...

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20:15

130: Revolutionizing Cell Therapy Manufacturing:...

Smart Biotech Scientist | The CMC and... ·

2025/02/20

Send 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, includin...

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22:10

129: Revolutionizing Cell Therapy Manufacturing:...

Smart Biotech Scientist | The CMC and... ·

2025/02/18

Send 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 manu...

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17:42

128: The 7 Hidden Innovation Habits That Top Biotech...

Smart Biotech Scientist | The CMC and... ·

2025/02/13

Send 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 biopro...

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15:53

127: The 7 Hidden Innovation Habits That Top Biotech...

Smart Biotech Scientist | The CMC and... ·

2025/02/11

Send 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 appr...

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20:31

126: How to Enhance Cell Engineering Using Mechanical...

Smart Biotech Scientist | The CMC and... ·

2025/02/06

Send us a text As biotechnology rapidly evolves, cell therapies are emerging as a groundbreaking frontier with the potential to transform medicine. In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann speaks with Armon Sharei, founder and CEO of Portal Bio, about the complexities, challenges, and future of cell therapies. Cell therapies could revolutionize medicine in ways similar to antibiotics and vaccines. However, the current manufacturing process is costly and tim...

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21:35

125: How to Enhance Cell Engineering Using Mechanical...

Smart Biotech Scientist | The CMC and... ·

2025/02/04

Send us a text Intracellular delivery is essential for advancing research and clinical applications, yet it presents unique challenges when working with different cell types and biomolecules. In a recent episode of the Smart Biotech Scientist podcast, David Brühlmann spoke with Armon Sharei, the founder and CEO of Portal Bio, about the future of cell therapy, the hurdles of intracellular delivery, and groundbreaking innovations in drug screening. Armon’s journey began at MIT, where his initia...

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17:32

124: Manufacturability: Why Most Protein Candidates...

Smart Biotech Scientist | The CMC and... ·

2025/01/30

Send us a textIn part two of our insightful conversation, Dr. Susan Sharfstein builds on our previous discussion of developability assessment to explore how AI is revolutionizing protein manufacturability predictions.As a Professor of Nanoscale Science and Engineering at the University of Albany, she shares groundbreaking insights from her collaboration with DeepSeq AI, demonstrating how artificial intelligence is transforming our ability to assess and predict protein manufacturability early ...

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22:35

123: Manufacturability: Why Most Protein Candidates...

Smart Biotech Scientist | The CMC and... ·

2025/01/28

Send us a textIn this eye-opening episode, we dive deep into the critical yet often overlooked world of protein manufacturability with Dr. Susan Sharfstein, Professor of Nanoscale Science and Engineering at the University of Albany. As part of the broader developability assessment process, manufacturability evaluation helps determine whether a therapeutic candidate can be successfully produced at commercial scale.Drawing from her extensive experience in bioprocessing and cell culture technolo...

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17:58

122: The Transformative World of Digital Solutions in...

Smart Biotech Scientist | The CMC and... ·

2025/01/23

Send us a textIn the second part of this conversation on digital solutions in bioprocessing, David Brühlmann and Simon Wieninger, Business Manager Digital Solutions at Eppendorf Group, discuss real-world examples of labs revolutionizing their workflows through smart digitalization. From real-time data monitoring to intercontinental data sharing, Simon highlights the practical benefits and exciting future potential of digital technologies in bioprocessing.Missed Part 1? In the previous episode...

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209 results

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