Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders

David Brühlmann - CMC Development Leader, Bioprocess Expert, Business Strategist
  • 5.0 (10)
  • Life Sciences
  • Updated Weekly

The go-to CMC and biomanufacturing podcast for bioprocess development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error. Practical, execution-focused, and strategic guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics for biologics, cell and gene therapies, cultivated meat, and biomaterials. 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 Scientist delivers actionable insights for the people doing the hard work of turning promising molecules into scalable, regulatory-ready therapies. This podcast is for you if: You are a process development scientist or CMC lead managing a technology transfer, scale-up, or CDMO partnership You are a biologics developer working on upstream or downstream process development, cell culture optimization, or GMP manufacturing readiness You are a biotech founder preparing for an IND filing or Series A fundraise, and need a CMC strategy that holds up under investor and regulatory scrutiny You are building or advising an early-stage biopharma team and need to make smart manufacturing decisions with limited resources What you will learn: CMC strategy and regulatory planning, bioprocess scale-up from lab to clinical and commercial manufacturing, cell culture process development and media optimization, technology transfer best practices, CDMO selection and partnership management, hybrid modeling, manufacturing economics, continuous manufacturing, digitization, and Industry 4.0 in biopharma. Top 10 life sciences podcast with 200+ episodes and guests from Merck, FUJIFILM Irvine Scientific, Cytiva, KBI Biopharma, Eppendorf, and biotech innovators worldwide. New episodes released weekly. Subscribe and join 400+ biotech leaders already using these insights to accelerate development, reduce manufacturing costs, and de-risk scale-up. Next Steps: Get the 5-day CMC email course: https://smartbiotechscientist.com/#cmc Visit the website: https://smartbiotechscientist.com Email us: hello@bruehlmann-consulting.com

  1. 1h ago

    298: 10,000 Structures Are Not Enough: The Data Gap Limiting De Novo Antibody Design with David Younger - Part 2

    The entire public record of antibody affinity data comes to about half a million measurements, and by David Younger's estimate, upwards of 75% of it is AlphaSeq data from his own company's publications. His conclusion is that no single company can close the gap alone. So he is asking pharma and AI labs to pay for an experiment and share every result with the other members. In Part 2 of this two-part conversation, David Brühlmann talks with Younger, founding CEO of A-Alpha Bio, whose AlphaSeq platform uses engineered yeast to measure protein interactions at scale. Part 1 set out the shortfall: about 10,000 antibody-antigen structures in the Protein Data Bank against a need of hundreds of thousands to millions. Here Younger explains how the consortium keeps proprietary targets out of the shared pool, who has joined, and why he believes it differs from federated learning. Topics discussed: Challenges faced by individual companies in generating sufficient data for effective AI models (02:17)How a data consortium enables pre-competitive data sharing while protecting proprietary information (06:13)Profiles of ideal consortium members and examples of current participants from pharma and AI model builders (08:36)The consortium’s current focus on VHH antibodies and plans for expansion to broader datasets and applications by 2030 (10:00)Comparison between the consortium approach and federated learning models in data sharing and collaboration (12:01)The main takeaways about the quantity and quality of data needed for machine learning in protein engineering (14:09)Smart insight: As David Younger envisions it, successful maturation of these consortia could fundamentally shift the field by 2030. Multiple consortia could address different scaffolds, data types, and problem statements, alleviating the bottleneck that has long constrained progress. The hope is that abundant, high-quality data will enable breakthrough therapeutic advancements while revealing new gaps that, in turn, inspire the next wave of innovation. Notably, David Younger sees collaboration—not just data scale—as the true secret weapon. Unlike federated learning, consortia incentivize members to share not just data, but experimental insights and best practices, effectively lifting all boats and accelerating collective progress. Curious how others are tackling the data problem in protein design? These episodes pick up right where David Younger leaves off. Episodes 185 - 186: How Generative AI Accelerates Protein Design for Biotech Discovery with Elise de ReusEpisodes 115 - 116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy AgrestiEpisodes 123 - 124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan SharfsteinEpisodes 219 - 220: From 10,000 Structures to 1.8 Billion Interactions: Breaking the Data Bottleneck to Engineer Efficacious Therapeutics with Troy LionbergerConnect with David Younger  Company website: www.aalphabio.com LinkedIn: www.linkedin.com/in/david-a-younger/ Data Atlas website: www.atlas.aalphabio.com Support the show

  2. 2d ago

    297: 10,000 Structures Are Not Enough: The Data Gap Limiting De Novo Antibody Design with David Younger - Part 1

    The Protein Data Bank holds about 10,000 antibody-antigen structures and grows by roughly 1,000 a year. David Younger's scaling work suggests that generalizable de novo antibody design needs hundreds of thousands to millions. At that pace, even 200,000 structures is nearly two centuries away. In this episode, David Brühlmann hosts David Younger, founding CEO of A-Alpha Bio and the mind behind the AlphaSeq platform. Trained at the intersection of synthetic biology and computational protein engineering, David Younger cut his teeth at the Institute for Protein Design and sharpened his focus on the stubborn gap between theoretical promise and practical performance. His approach rewrites the rules of data generation—scaling up both the volume and the insight from protein interaction data to deliver the kind of information AI needs to actually make an impact in therapeutic design. Topics discussed: Bottlenecks caused by insufficient and low-quality data in AI-enabled protein engineering (02:53)The limitations of traditional protein discovery methods and the persisting role of serendipity in antibody development (08:02)An overview of the AlphaSeq platform and how it enables large-scale measurement of protein interactions using engineered yeast (10:50)The differences between measuring protein-protein affinities with conventional techniques and AlphaSeq’s batch approach, including cost and speed advantages (16:54)Strategies for generating training data for machine learning models in protein engineering, including the need for structural and affinity data (18:23)The value and limitations of the Protein Data Bank (PDB) in training de novo design models (20:17)The challenge of benchmarking foundational models for protein engineering and the need for universal industry standards (23:11)Smart insight: The future of biotherapeutic innovation is intertwined with a simple truth: more and better data unlock AI’s true potential. With breakthrough wet-lab technologies like AlphaSeq, and commitment to openness and benchmarking, the dream of efficient, precise, and truly rational protein engineering may soon become reality. The next big leap in biotech is not just smarter algorithms—but the scale, quality, and transparency of the data that powers them. Curious how others are tackling the data problem in protein design? These episodes pick up right where David Younger leaves off. Episodes 185 - 186: How Generative AI Accelerates Protein Design for Biotech Discovery with Elise de ReusEpisodes 115 - 116: Revolutionizing Biologics Development with Hyper Throughput Screening and AI with Jeremy AgrestiEpisodes 123 - 124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan SharfsteinEpisodes 219 - 220: From 10,000 Structures to 1.8 Billion Interactions: Breaking the Data Bottleneck to Engineer Efficacious Therapeutics with Troy LionbergerConnect with David Younger  Company website: www.aalphabio.com LinkedIn: www.linkedin.com/in/david-a-younger/ Data Atlas website: www.atlas.aalphabio.com Free 5-day email course, The CMC Failure Chain: the five recurring CMC mistakes that put your promising program at risk → Get it here Support the show

  3. Oct 15

    296: Neither Small Molecule nor Biologic: The Cyclodextrin Dimer CMC Challenge with Matthew O'Connor - Part 2

    Cardiovascular disease has long been managed by slowing its relentless progression. But Matthew O'Connor, CEO of Scientific Affairs at Cyclarity Therapeutics, is betting on an outright paradigm shift: treating atherosclerotic plaque with therapies designed to actively reverse disease, not simply manage symptoms or risk. In this episode, David Brühlmann explores the strategy, regulatory journey, and manufacturing realities behind Cyclarity's unconventional cyclodextrin-based approach—a molecule sitting at the crossroads of small and large molecule drug development. Topics discussed: Insights into the company's clinical development progress, including completion of a first-in-human study and what comes next (02:47)How the FDA views drugs that don't fit traditional categories and how this influences development pathways (04:35)The challenges and considerations in demonstrating efficacy for drugs designed to reduce heart attacks and strokes (05:22)Cost considerations in manufacturing the cyclodextrin dimer and how it compares to biologics and GLP-1 drugs (08:14)Vision for how cardiovascular disease may be diagnosed and treated a decade from now, including the role of imaging and prevention (10:24)Broader implications for treating age-related diseases by targeting toxic metabolites in the body (14:25)Why next-generation therapeutics may be built not by sticking to old modalities but by tackling root causes with custom solutions (16:10)Reflections on making new drugs both safe and fundamentally beneficial, minimizing side effects (17:10)Smart insight: Start with the problem, not the modality. Matthew O'Connor argues that instead of defaulting to an antibody, a small molecule or a gene therapy, developers should build a custom solution to the problem they're trying to solve. A drug that suppresses a pathway across the whole body brings side effects you have to manage. A drug that removes something harmful, like oxidized cholesterol, can have side effects that are actually beneficial. His goal for the next generation of drugs is ones that simply make people healthier. When a drug is too big to be a small molecule and too small to be a biologic, every CMC decision gets harder. These episodes look at what it takes to develop, characterize and manufacture a modality that doesn't fit an existing box. Episodes 281 - 282: When Your Delivery Vehicle Contains a Membrane Protein: CMC Decisions With No Regulatory Precedent with Jitendra KumarEpisodes 207 - 208: Cryogenic Infrared Ion Spectroscopy: From Mass Spec Limitations to Molecular Precision with Tom RizzoEpisodes 197 - 198: Mastering ADC Development: CDMO Strategies for Analytics and Scale-Up with Amanda HoertzEpisodes 231 - 232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri KornmannConnect with Matthew O'Connor: Website: www.cyclaritytx.com LinkedIn: www.linkedin.com/in/droki Email: matthew.oconnor@cyclaritytx.com Free 5-day email course, The CMC Failure Chain: the five recurring CMC mistakes that put your promising program at risk → Get it here Support the show

  4. Oct 13

    295: Neither Small Molecule nor Biologic: The Cyclodextrin Dimer CMC Challenge with Matthew O'Connor - Part 1

    Why does CMC development still expect every drug to be one molecule with one peak, when new therapeutics don't always fit neatly into existing regulatory or chemical categories? Matthew O'Connor, CEO of Scientific Affairs at Cyclarity Therapeutics, is developing a drug that sits between a small molecule and a biologic. On the Smart Biotech Scientist Podcast, Matthew shared how his team engineered a cyclodextrin dimer that binds and removes 7-ketocholesterol, an oxidized form of cholesterol that builds up in artery plaque and is linked to a higher risk of heart attack and stroke. Topics discussed: Matthew O'Connor's motivation for focusing on aging and molecular damage (03:39)The biological problem of oxidized cholesterol buildup and its role in atherosclerosis (04:42)Mechanism of action: how the cyclodextrin binds and removes 7-ketocholesterol (06:23)Approaches to designing a highly specific cyclodextrin therapeutic (09:14)The "medium-sized molecule" characteristics and the question of regulatory classification (12:16)Why cyclodextrin starting material is cheap and not a manufacturing bottleneck (15:37)Manufacturing strategies and the role of specialist CDMOs in complex carbohydrate chemistry (17:04)Methods for demonstrating identity and consistency in isomeric mixtures (18:43)Drug formulation considerations and why an injectable route is necessary (21:46)Smart insight: Matthew O'Connor's work shows what happens when you start with the problem rather than the drug format. His team's cyclodextrin dimer doesn't fit neatly as a small molecule or a biologic, and that makes manufacturing, analytics and regulatory work harder. But if it can remove oxidized cholesterol from the body, it could help reverse plaque instead of just slowing it down. When a drug is too big to be a small molecule and too small to be a biologic, every CMC decision gets harder. These episodes look at what it takes to develop, characterize and manufacture a modality that doesn't fit an existing box. Episodes 281 - 282: When Your Delivery Vehicle Contains a Membrane Protein: CMC Decisions With No Regulatory Precedent with Jitendra KumarEpisodes 207 - 208: Cryogenic Infrared Ion Spectroscopy: From Mass Spec Limitations to Molecular Precision with Tom RizzoEpisodes 197 - 198: Mastering ADC Development: CDMO Strategies for Analytics and Scale-Up with Amanda HoertzEpisodes 231 - 232: From IND to BLA: The Biologics CMC Decisions That Determine Regulatory Success with Henri KornmannConnect with Matthew O'Connor: Website: www.cyclaritytx.com LinkedIn: www.linkedin.com/in/droki Email: matthew.oconnor@cyclaritytx.com Free 5-day email course, The CMC Failure Chain: the five recurring CMC mistakes that put your promising program at risk → Get it here Support the show

  5. Oct 8

    294: Is CFD Overkill for Your Scale-Up? Why It Belongs in Every Biotech Scientist's Toolkit with Christian Witz - Part 2

    Scale-up doesn't fail because the science was wrong. It fails because a cell's environment in a shake flask has little in common with its environment in a bioreactor. Christian Witz has spent years building the tools to close that gap: simulating exactly what a cell experiences as it moves from bench to plant, before a single liter is wasted finding out the hard way. Continuing from Part 1, David Brühlmann and Christian Witz, CEO and founder of SimVantage, go deeper into how CFD moves from theory to daily practice: validating simulation results, scaling real cell therapy and Streptomyces processes, and an active FDA-backed project on residence time distribution in continuous bioprocessing. Topics discussed: Why data validation is crucial in CFD simulations and how to interpret and trust simulation results (02:39)Real-world examples of scaling up from shake flasks to stirred tank reactors using CFD, including specific collaborations and cell therapy case studies (05:40)Technical and validation challenges in simulating fluid dynamics in shake flasks and integrating these results into scale-up strategies (08:14)Ongoing FDA-backed project to model residence time distribution in continuous bioprocessing and its regulatory significance (11:49)The increasing openness of regulators like the FDA to include CFD data in submissions and relevant guidelines for simulation credibility (13:23)Advice for small biotech teams on when and how to start using CFD in CMC development and scale-up planning (15:06)Insights on the future of bioprocessing, including virtual scale-up, digital reactor repositories, and the democratization of CFD tools (18:20)Smart insight: Christian Witz advised that teams begin CFD modeling as early as concept development. CFD not only helps choose the right equipment—even when working with contract manufacturers—but creates a digital process record that reduces experimental burden, shortens timelines, and impresses investors with its risk mitigation. If this conversation got you rethinking your scale-up strategy, here are a few past episodes that go deeper on the pieces Christian touched on: Episodes 91 - 92 : Mass Transfer Secrets: Mastering Bubbles and kLa from Bench to Large-Scale Production with Lars Puiman & Rik VolgerEpisodes 245 - 246: Why Your Shake Flask Culture Doesn't Scale: OTR, Shaking Diameter, and How to Fix It with Tibor AnderleiEpisodes 173 - 174: Mastering Hybrid Model Digital Twins: From Lab Scale to Commercial Bioprocessing with Krist GernaeyEpisode 243: Turn Tech Transfer from a Gamble into a Managed Process: The 6-Pillar Biologics Scale-Up FrameworkConnect with Christian Witz: Website: www.simvantage.com Christian’s LinkedIn: www.linkedin.com/in/christian-witz-84aa9b162/ Christian’s email: christian.witz@simvantage.com Free 5-day email course, The CMC Failure Chain: the five recurring CMC mistakes that put your promising program at risk → Get it here Support the show

  6. Oct 6

    293: Is CFD Overkill for Your Scale-Up? Why It Belongs in Every Biotech Scientist's Toolkit with Christian Witz - Part 1

    You've perfected your process at the bench. Now comes the part that keeps CMC scientists up at night: will it still work at 2,000L? Right now, most teams find out the hard way, through failed runs, wasted batches, and months of delay to patients waiting on a therapy. Christian Witz believes there's a better way: use computational fluid dynamics to see how your cells will actually behave at full scale before you ever run the process, and stop treating scale-up as a guessing game. On this episode of the Smart Biotech Scientist Podcast, David Brühlmann talks with Christian, founder of SimVantage, about why he treats CFD as a tool every process engineer should use directly, not something you outsource to a specialist. Christian's path into biotech ran through heat pump simulations and GPU-based particle flow modeling before he rebuilt a legacy Fortran bioreactor simulation program in modern C++ and CUDA, work that became the foundation of SimVantage. Topics discussed: Christian’s path from simulating heat pumps and particle flows to pioneering GPU-based bioreactor simulations (03:54)The surprising lack of full equipment characterization in the biotech industry compared to fields like oil, gas, and iron & steel (06:40)The interdisciplinary challenges and steep learning curve when entering biotech from other industries (08:07)Why academic spinouts matter and the practical realities of founding a company based on university-developed software (09:44)Reasons behind CFD’s low adoption in bioprocessing—perceived complexity, need for specialists, and historical limitations in algorithms and computing power (11:58)How recent advances in GPU power, algorithms, and cloud computing remove barriers for routine use of CFD in process development (14:35)Strategies for characterizing and scaling processes across various reactor types, from shake flasks to manufacturing reactors (16:39)Practical considerations and limitations when setting up comprehensive CFD characterizations, including simulation parameter choices (19:49)Smart insight: The degree of reactor characterization depends on a company’s needs. Startups might analyze a scale-up project once, while contract manufacturers—handling diverse products—benefit from comprehensive, reusable characterization across all reactors and operating conditions. Simulations are guided by physics (density, viscosity, surface tension) rather than biological specifics, allowing quick adaptation to new media or cell types. If this conversation got you rethinking your scale-up strategy, here are a few past episodes that go deeper on the pieces Christian touched on: Episodes 91 - 92 : Mass Transfer Secrets: Mastering Bubbles and kLa from Bench to Large-Scale Production with Lars Puiman & Rik VolgerEpisodes 245 - 246: Why Your Shake Flask Culture Doesn't Scale: OTR, Shaking Diameter, and How to Fix It with Tibor AnderleiEpisodes 173 - 174: Mastering Hybrid Model Digital Twins: From Lab Scale to Commercial Bioprocessing with Krist GernaeyEpisode 243: Turn Tech Transfer from a Gamble into a Managed Process: The 6-Pillar Biologics Scale-Up FrameworkConnect with Christian Witz: Website: www.simvantage.com Christian’s LinkedIn: www.linkedin.com/in/christian-witz-84aa9b162/ Christian’s email: christian.witz@simvantage.com Free 5-day email course, The CMC Failure Chain: the five recurring CMC mistakes that put your promising program at risk → Get it here Support the show

  7. Oct 1

    292: The Fool's Game That Became Standard Practice: Perfusion, the ATF, and What Changed with John Bonham-Carter - Part 2

    Biotech founders often pour everything into building the “perfect” product only to realize their real customers have walked out the door. Chasing perfection can burn money and stall even the most promising CMC innovations. In this episode, David Brühlmann continues his conversation with biotech entrepreneur and investor John Bonham-Carter. John shares his insights on the realities of building and scaling successful biotools companies, from the challenges of fundraising and the importance of authentic storytelling, to knowing when to stop perfecting a product and start selling. Topics discussed: How fundraising is less about money and more about the story, team, and real commitment behind a startup (02:33)Practical advice for founders: obsess over the customer, not just the technology (07:14)The dangers of spreading yourself too thin as a startup founder and lessons from parenting applied to startups (07:09)Choosing business partners and collaborators whose skills complement your own—and making peace with imperfection (10:10)John’s approach to building teams and why accepting mediocrity in some areas can lead to collective excellence (11:16)The story behind John joining Stellion Biosystems, and what makes their cell counting technology different in the market (11:51)Using creative, low-budget tactics for visibility—why John chose a lizard mascot for Stellion Biosystems (15:19)Thoughts on when (if ever) to stop and the value of keeping multiple life and career doors open (17:26)John’s main takeaway: “Try everything”—professional advice drawn from experience (and Zootopia) (19:01)Smart insight: John leaves us with a simple yet powerful credo: “Try everything.” In biotech, that means embracing experimentation not just in the lab, but in business strategy, partnerships, hiring, and technology adoption. By collaborating, iterating, and listening closely to customers, you can grow, succeed, and—perhaps—build something that truly makes a difference. In a field where the only constant is change, remember: launch before you’re ready, find your people, and keep your story genuine. Some ideas are ahead of their time; a few people make a career of being early. This is part bioprocess history, part founder's playbook: why the best technology doesn't automatically win, how to move a conservative industry, and when to sell rather than scale. To go further on both the technology and the business behind it: Episodes 191 - 192: Process Intensification Secrets: A Process Engineer's Decision Framework with Andreas CastanEpisodes 183 - 184: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee HoEpisodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael RomeEpisodes 165 - 166: Why Your Funding Pitches Fail Despite Brilliant Science (And How to Fix It)Connect with John Bonham-Carter: Website: www.stellion-biosystems.com LinkedIn: www.linkedin.com/in/johnbc Free 5-day email course, The CMC Failure Chain: the five recurring CMC mistakes that put your promising program at risk → Get it here Support the show

  8. Sep 29

    291: The Fool's Game That Became Standard Practice: Perfusion, the ATF, and What Changed with John Bonham-Carter - Part 1

    Biotech loves talk of disruptive technology, but few have repeatedly shifted the industry's direction. This episode of the Smart Biotech Scientist Podcast focuses on an idea once dismissed as a fool's game: process intensification through perfusion—now the backbone of leading biomanufacturing platforms. Meet John Bonham-Carter, a serial entrepreneur whose fingerprints are on some of biotech's most transformative tools. From putting the once-ignored ATF system and perfusion on the global stage to pushing intensified cell therapy bioprocessing with ERBI, John's story isn't about chasing the next big exit. Instead, it's about spotting unmet needs and building and selling biotools companies more than once. Topics discussed: The story behind the ATF system, and how John Bonham-Carter and his collaborators convinced a conservative industry to adopt perfusion (04:43)Early career influences, including family ties to bioprocess equipment manufacturing (05:03)Reflections on the biotech industry’s culture of collaboration and the dual motivation to deliver medicines and achieve commercial success (07:18)Realities of scaling a startup, trading income for equity, and the role of persistence in sales (09:34)Lessons learned from global travel and building professional networks in biotech (10:16)The importance of recognizing what drives different biotech companies to adopt new technology (12:25)The transition from ATF to co-founding Erbi, a bioprocessing startup focused on small-volume cell therapy (19:05)Strategic acquisitions: experiences of being acquired by Repligen and Merck Millipore (22:50)Advice for founders on whether to build a company for exit or long-term operation (23:07)The limits of leading with technology, and why customer understanding is critical to success (26:10)Smart insight: For founders, John Bonham-Carter offers practical guidance anchored in self-awareness. Should you build a company for the long haul or for acquisition? The answer: “There isn’t really a right answer...it is, what is the life you want to lead?” Some entrepreneurs thrive at the scale of ten-person teams and relish the handoff to a strategic acquirer. Others yearn to build and steer a 200-person enterprise. Regardless, serving customers and employees well, and being attuned to the market’s shifting demands, matter most. Exit opportunities arise from building value and strategic fit—not from fixating on selling out. Some ideas are ahead of their time; a few people make a career of being early. This is part bioprocess history, part founder's playbook: why the best technology doesn't automatically win, how to move a conservative industry, and when to sell rather than scale. To go further on both the technology and the business behind it: Episodes 191 - 192: Process Intensification Secrets: A Process Engineer's Decision Framework with Andreas CastanEpisodes 183 - 184: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee HoEpisodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael RomeEpisodes 165 - 166: Why Your Funding Pitches Fail Despite Brilliant Science (And How to Fix It)Connect with John Bonham-Carter: Website: www.stellion-biosystems.com LinkedIn: www.linkedin.com/in/johnbc Free 5-day email course, The CMC Failure Chain: the five recurring CMC mistakes that put your promising program at risk → Get it here Support the show

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The go-to CMC and biomanufacturing podcast for bioprocess development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error. Practical, execution-focused, and strategic guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics for biologics, cell and gene therapies, cultivated meat, and biomaterials. 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 Scientist delivers actionable insights for the people doing the hard work of turning promising molecules into scalable, regulatory-ready therapies. This podcast is for you if: You are a process development scientist or CMC lead managing a technology transfer, scale-up, or CDMO partnership You are a biologics developer working on upstream or downstream process development, cell culture optimization, or GMP manufacturing readiness You are a biotech founder preparing for an IND filing or Series A fundraise, and need a CMC strategy that holds up under investor and regulatory scrutiny You are building or advising an early-stage biopharma team and need to make smart manufacturing decisions with limited resources What you will learn: CMC strategy and regulatory planning, bioprocess scale-up from lab to clinical and commercial manufacturing, cell culture process development and media optimization, technology transfer best practices, CDMO selection and partnership management, hybrid modeling, manufacturing economics, continuous manufacturing, digitization, and Industry 4.0 in biopharma. Top 10 life sciences podcast with 200+ episodes and guests from Merck, FUJIFILM Irvine Scientific, Cytiva, KBI Biopharma, Eppendorf, and biotech innovators worldwide. New episodes released weekly. Subscribe and join 400+ biotech leaders already using these insights to accelerate development, reduce manufacturing costs, and de-risk scale-up. Next Steps: Get the 5-day CMC email course: https://smartbiotechscientist.com/#cmc Visit the website: https://smartbiotechscientist.com Email us: hello@bruehlmann-consulting.com

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