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

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

  1. hace 21 h

    278: Your Bioprocess Data Already Holds 35% More Yield: From End-to-End Models to Digital Twins with Ignasi Bofarull-Manzano - Part 2

    How do you take a model that works in process development and get it accepted for use in GMP manufacturing? That question stalls most bioprocess modeling projects before they start. Ignasi Bofarull-Manzano, Senior Data Scientist and CMC Consultant at Körber Pharma, pushes back on the premise: the process you run today is already governed by a mathematical model, fitted once at small scale during process characterization and then left untouched for years, even as the process shifts. Part 1 separated digital models from digital shadows and digital twins, and made the case for starting with the decision rather than the data. Part 2 goes into the plant: what regulators actually require, what the numbers looked like on a real biologics process, and where a team should start on Monday morning. Topics covered: Core differences—and surprising similarities—between modeling in development versus manufacturing (02:35)Regulatory requirements: credibility assessments, model risk, and validation steps for digital twins (05:07)Real-world example: How deploying an end-to-end process model led to 35% yield increase for Takeda, and considerations for ROI in manufacturing (08:34)Advice for startup leaders on when to invest in modeling and how to scale efforts case-by-case (11:42)Steps for scientists new to modeling: identifying bottlenecks, starting simple, and proving value offline before scaling up (12:26)The importance of understanding basic statistics before relying on AI-generated models (15:22)A stepwise summary for deploying digital modeling effectively in biotech (16:01)Smart insight: The digital twin is the last step, not the first. Identify the bottleneck, build the simplest model that supports the decision, and concatenate it end to end so you can see how a parameter moves final drug substance quality rather than one unit operation's output. Prove the value offline. Only then connect interfaces, because that is where the cost and the validation burden live. Teams that lead with the twin arrive at the C-level with a proof of concept and no evidence. Teams that lead with the offline model arrive with a number. Before a digital twin can earn its keep, you need connected data, the right model, and a clear decision for it to support. These four episodes cover that ground — data silos, hybrid and mechanistic modeling, and twins built to survive regulatory scrutiny. Episodes 215 - 216: From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up with Ilya BurkovEpisodes 05 - 06: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael SokolovEpisodes 17 - 18: How Extracting Gold From Your Data Accelerates Process Development with Ioscani Jiménez del ValEpisodes 263 - 264: Why AI and Automation Tools Won't Deliver Until Your Lab's Data Is Connected with David HardyConnect with Ignasi Bofarull-Manzano: LinkedIn: www.linkedin.com/in/ignasi-bofarull Körber Pharma website: www.koerber-pharma.com Support the show

  2. hace 2 días

    277: Your Bioprocess Data Already Holds 35% More Yield: From End-to-End Models to Digital Twins with Ignasi Bofarull-Manzano - Part 1

    Most bioprocess teams believe a digital twin demands vast datasets and sophisticated models. Ignasi Bofarull-Manzano argues both assumptions are wrong, and that the data already sitting in your Excel files, historians and ELNs is probably enough to start. Ignasi Bofarull-Manzano, Senior Data Scientist and CMC Consultant at Körber Pharma, breaks down what a digital twin actually is, where modeling pays back fastest across the product lifecycle, and how to tell a real business case from an expensive proof of concept. In this episode: Misconceptions about data requirements for digital twins—why quality and context of data matter more than sheer quantity (02:40)Ignasi’s journey from curiosity in biology to a career in data science, modeling, and digital twins (04:31)Clear distinctions between digital models, digital shadows, and digital twins, explained with real-world analogies (06:42)How to approach digital development when faced with legacy data silos and scattered analytics (09:56)The importance of starting with a focused business need instead of chasing trends or buzzwords (12:28)Insights into where modeling truly delivers value in the product lifecycle—development versus manufacturing (13:11)Strategies for small companies to leverage digitalization and data from the ground up (15:56)An accessible overview of physics-informed AI, physical AI, and hybrid modeling—and their application in bioprocessing (18:15)The comparative advantages of physics-informed AI versus hybrid models in different bioprocessing contexts (24:45)Smart insight: Do not start with the model. Start with the bottleneck. Identify the business need first, then the decision the model must support, then the minimum data required for that context of use. Build the model offline, concatenate it end to end across unit operations rather than optimizing one in isolation, and prove the value before connecting a single interface. Teams that skip this sequence end up building models because models sound impressive, and those projects get expensive before they get useful. Before a digital twin can earn its keep, you need connected data, the right model, and a clear decision for it to support. These four episodes cover that ground — data silos, hybrid and mechanistic modeling, and twins built to survive regulatory scrutiny. Episodes 215 - 216: From Data Silos to Autonomous Biomanufacturing: Digital Twins and AI-Driven Scale-Up with Ilya BurkovEpisodes 05 - 06: Hybrid Modeling: The Key to Smarter Bioprocessing with Michael SokolovEpisodes 17 - 18: How Extracting Gold From Your Data Accelerates Process Development with Ioscani Jiménez del ValEpisodes 263 - 264: Why AI and Automation Tools Won't Deliver Until Your Lab's Data Is Connected with David HardyConnect with Ignasi Bofarull-Manzano: LinkedIn: www.linkedin.com/in/ignasi-bofarull Körber Pharma website: www.koerber-pharma.com Support the show

  3. 6 ago

    276: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 2

    How do you turn a lab-born regenerative medical device into a solution that surgeons actually want to use and investors want to back? The path from academic innovation to clinical adoption is full of practical hurdles and strategic pivots, where compelling science alone isn’t enough. David Brühlmann welcomes back Eva-Maria Balet, whose journey spans tissue engineering research at EPFL to leading Regenosca through first-in-human trials, fundraising, and an executive MBA completed while running the company. This conversation covers the practical realities behind that journey, from quality control to clinical setbacks to investor pitches. Topics discussed: Defining TissueSpan’s regulatory path and quality control as a medical device (02:49)The significance of first-in-human studies and what early clinical experience reveals (04:11)Selecting an initial clinical indication and opportunities for technology expansion (05:50)Realistic assessment of where soft tissue repair technologies apply—and where they do not (07:18)The stepwise progression from in vitro to animal models in product development (08:18)Navigating setbacks, including the impact of Covid-19 on clinical trials, and the value of adaptability (10:36)Bridging science and business in biotech fundraising and communication (12:15)Key takeaways from pursuing an executive MBA alongside building a biotech company (13:42)The importance of collaboration, mindset, and meaningful networks in driving biotech innovation (15:19)Smart insight: The transition from scientist to founder brought its own learning curve. Eva-Maria pursued an executive MBA while running Regenosca, and points to financial and business vocabulary as the skill she'd have built earlier if she could. For a technical founder or CMC lead, the lesson isn't to become a business generalist, it's that the moment you're translating a manufacturing process or clinical dataset into an investor pitch, fluency in the language of accounting, market strategy, and cost structure becomes as load-bearing as the science itself. This week's episode with Eva-Maria Balet steps out of bioprocessing into MedTech, following a collagen scaffold from EPFL lab bench to first-in-human implant. These back-catalog picks cover similar ground: what it takes to win investor buy-in beyond the science, the discipline of turning a lab process into GMP manufacturing, why regulatory classification shapes a product's whole trajectory, and what it really takes to commercialize a lab discovery. Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael RomeEpisodes 257 - 258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan TomicEpisodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver KraemerEpisodes 183 - 184: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee HoConnect with Eva-Maria Balet: LinkedIn: www.linkedin.com/in/eva-maria-balet-72561737 Regenosca website: www.regenosca.com Support the show

  4. 4 ago

    275: From Lab-Scale Molding to GMP: Manufacturing a Collagen Implant for the Clinic with Eva-Maria Balet - Part 1

    Imagine a wound too large for the body to close on its own. That's the problem Eva-Maria Balet set out to solve, not with living cells, but with a structural bridge that lets the body's own healing mechanisms do the rest. In this episode, David Brühlmann welcomes Eva-Maria Balet, Co-Founder & CEO of Regenosca. Trained at EPFL, Eva-Maria brought her fascination with cellular "factories" from academia straight into entrepreneurship. Rather than chasing elegant science for its own sake, she built her company around a single principle: start with a real clinical need and build backward, collaborating with clinicians from day one so every experiment serves a patient. Highlights & Topics: Why starting with clinical needs—not just scientific excitement—creates meaningful real-world impact in life sciences (02:38)How Eva-Maria’s fascination with biotechnology guided her from cell factories to developing scaffolds for tissue repair (03:51)The unmet challenges in current soft tissue repair treatments and where new solutions are needed (05:51)What makes Regenosca’s fully-engineered collagen implant, TissueSpan, different from existing meshes and biological materials (07:09)The biological mechanisms behind tissue regeneration using a temporary collagen scaffold (08:28)Translating lab-scale research into a robust, scalable, and regulatory-compliant production process (10:34)The practical realities and hurdles of navigating the medical device vs. biologic regulatory pathways (11:59)Advice on building regulatory expertise into your founding team or leveraging consultants effectively (13:31)The importance of interdisciplinary teams and trust when forming biotech startups (14:36)Smart insight: Eva-Maria put it plainly: what works in the lab has to work reliably every single time you produce it for a patient. That shift, from proving a concept to controlling a process, from raw materials through in-process controls to final product testing, is the same discipline any CMC scientist recognizes: science alone doesn't get a product to patients. Reproducibility does. This week's episode with Eva-Maria Balet steps out of bioprocessing into MedTech, following a collagen scaffold from EPFL lab bench to first-in-human implant. These back-catalog picks cover similar ground: what it takes to win investor buy-in beyond the science, the discipline of turning a lab process into GMP manufacturing, why regulatory classification shapes a product's whole trajectory, and what it really takes to commercialize a lab discovery. Episodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael RomeEpisodes 257 - 258: Why Regulatory Affairs Belongs in Drug Design: 30 Years of CMC Lessons from Discovery to GMP Manufacturing with Milan TomicEpisodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren't Just Complex Biologics with Oliver KraemerEpisodes 183 - 184: From Lab to Market: Secrets to Commercializing Cutting-Edge Biotech Innovations with Chervee HoConnect with Eva-Maria Balet: LinkedIn: www.linkedin.com/in/eva-maria-balet-72561737 Regenosca website: www.regenosca.com Support the show

  5. 30 jul

    274: Engineering iPSC Neurons for Parkinson's: From 3% Survival to Durable Graft with Bilal Fares - Part 2

    Building a cell therapy company is hard. Building a genetically engineered iPSC therapy for the brain, on a preclinical budget, is one of the hardest translational problems in biotech. Every experiment has to move the program closer to an IND, or it's motion without progress. That's the operating constraint Bilal Fares faces as CEO and co-founder of AzureCell, the University of Geneva spin-off engineering neuroprotective iPSC neurons for Parkinson's disease. In Part 2, he walks through how his team decides what to build, where AI and synthetic biology genuinely accelerate a CMC roadmap, and the four founder lessons he wishes he'd internalized earlier, including his conviction that scientists who use AI will replace those who don't. Topics discussed include: Strategies for prioritizing experiments and narrowing focus with limited resources (03:33)How business opportunity validation programs helped define a product roadmap (04:08)Integrating AI and synthetic biology into research programs—and where these tools do, and don’t, accelerate development (05:07)Building a cell therapy platform for personalized approaches in neurological diseases beyond Parkinson’s (06:38)Lessons learned in biotech leadership and why tackling big problems matters (08:08)Key advice for aspiring biotech entrepreneurs: kill your own solutions quickly, and learn from others (09:27)The importance of having a strong team and how a powerful mission attracts top talent (12:21)AzureCell’s near-term plans and future goals, including upcoming fundraising and R&D milestones (13:30)Smart insight: What separates successful biotech ventures from the rest? According to Bilal Fares, it is not just technical skill but mindset. First, choose a problem large enough to be worth the struggle. Second, try to “kill your solution as fast as possible”—engage experts, enter competitions, and seek brutal feedback early so you can pivot, improve, or abandon as needed. And finally, plan with the end (approval, patients, impact) always in sight. If you enjoyed this, check out these episodes on cell therapy, where engineered cells can survive and do more than replace what's lost: Michael Rome's investor lens rounds it out for founders facing the same funding realities. Episodes 269 - 270: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung WooEpisodes 253 - 254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta LeeEpisodes 249 - 250: How T Cell Activation Redefines TIL and CAR-T Manufacturing (Boosting Success Rates to 95%) with Chantale BernatchezEpisodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael RomeConnect with Bilal Fares: LinkedIn: www.linkedin.com/in/b-fares AzureCell website: www.azurecell.co Email: info@azurecell.co Support the show

  6. 28 jul

    273: Engineering iPSC Neurons for Parkinson's: From 3% Survival to Durable Graft with Bilal Fares - Part 1

    Transplant iPSC-derived neurons into a Parkinson's brain and 97% die before they can restore function. Of the 3% that survive, most face the same pathogenic environment that killed the original neurons. This is the compounded biology and CMC problem defining CNS cell therapy today. Bilal Fares, neuroscience entrepreneur and co-founder of AzureCell, is translating a University of Geneva discovery into a genetically engineered iPSC platform built to solve it: neurons that don't just replace what Parkinson's destroyed, but survive the fire that destroyed them. Topics discussed: Why Bilal believes cell therapy is the future of medicine for brain diseases, and the limitations of other approaches (03:06)Bilal’s personal story and the events that guided his commitment to Parkinson’s research and entrepreneurship (04:03)How cell therapy might move beyond simply replacing lost neurons—using engineered cells to produce therapeutics directly in the brain (09:05)The neuroprotective technology AzureCell is developing, designed to shield transplanted neurons from Parkinson’s disease mechanisms (11:31)The platform approach: combining stem cell technologies, genetic engineering, and allogeneic off-the-shelf cell banks (12:38)Why the blood-brain barrier makes cell therapy a necessary approach for certain conditions (13:26)The current status of Azure’s preclinical and manufacturing development, and their plans for clinical translation (14:31)Why previous therapies for Parkinson’s have fallen short, and how cell therapy might sidestep these limitations (15:57)The potential and challenges of using cell therapy for other brain diseases like Alzheimer’s (18:26)Smart insight: The next generation of CNS cell therapy isn't only about neuron replacement. Bilal's thesis reframes transplanted cells as engineered biological factories inside the brain: producing neuroprotective proteins, modulating disease mechanisms in real time, and eventually enabling preventative treatment as manufacturing costs fall and safety matures. If you enjoyed this, check out these episodes on cell therapy, where engineered cells can survive and do more than replace what's lost: Michael Rome's investor lens rounds it out for founders facing the same funding realities. Episodes 269 - 270: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung WooEpisodes 253 - 254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta LeeEpisodes 249 - 250: How T Cell Activation Redefines TIL and CAR-T Manufacturing (Boosting Success Rates to 95%) with Chantale BernatchezEpisodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael RomeConnect with Bilal Fares: LinkedIn: www.linkedin.com/in/b-fares AzureCell website: www.azurecell.co Email: info@azurecell.co Support the show

  7. 23 jul

    272: From Static Scaffolds to Dynamic Matrices: Hydrogels for Animal-Free 3D Cell Culture with Jan Hunik and Matt Baker - Part 2

    How much of your research lives and dies on the bench? Not because the idea isn’t sound, but because building reproducible, scalable biomaterials remains an unsolved puzzle. Jan Hunik and Matt Baker from MosaMatrix discuss the practical challenges and lessons learned from spinning out a biomaterials company from academia. They explore the importance of quality standards in biotech startups, building a team with complementary skills, and the realities of developing reproducible 3D culture systems for modern research. Topics discussed: The critical gap between invention and reliable biomaterial products (00:40)Building company culture around quality standards from day one (02:45)Balancing scientific curiosity and business direction as co-founders (03:51)The impact of university partnerships on early-stage company development (06:02)Funding challenges and strategies for sustaining a biotech startup (06:47)Advice for scientists on addressing real market needs versus pushing technology (07:50)The importance of listening to customers and investors to find product-market fit (09:19)Vision for scaling technology and breaking even in the next two to three years (10:06)New frontiers in engineering living materials and animal-free biomaterials (12:04)Smart insight: The MosaMatrix team believes good materials are key to unlocking advances in drug discovery, cellular agriculture, and engineered living materials. Their story is a testament to how integrating rigorous science, business discipline, and a razor focus on real-world needs can create the foundation for lasting innovation in biotech. If this conversation got you thinking about biomaterials, scale-out manufacturing, and what it takes to turn a chemistry breakthrough into a fundable company, these episodes explore the same ground from complementary angles. Episodes 221 - 222: From 2D Cultures to Advanced 3D Cell Models for Preclinical Research with Catarina BritoEpisodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael RomeEpisodes 265 - 266: From Human Variability to Automated Precision: Accelerating Cell and Gene Therapy Manufacturing Scale-Out with Farlan VeraitchEpisodes 223 - 224: From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up with Steven LangConnect with Jan Hunik and Matt Baker: Emails: matt.baker@mosamatrix.com and jan.hunik@mosamatrix.comWebsite: www.mosamatrix.comLinkedIn Jan Hunik: www.linkedin.com/in/jan-hunik-0183734LinkedIn Matt Baker: www.linkedin.com/in/matthew-baker-0abb981bSupport the show

  8. 21 jul

    271: From Static Scaffolds to Dynamic Matrices: Hydrogels for Animal-Free 3D Cell Culture with Jan Hunik and Matt Baker - Part 1

    What if the real obstacle in 3D cell culture and tissue engineering isn't the cells, but the very ground they grow on? For years, cell culture has relied on flat plastic and passive scaffolds. But biology doesn't happen on a petri dish—cells live in three dimensions, surrounded by a dynamic environment that talks back, adapts, and shapes development in ways static gels simply cannot. That's the premise behind MosaMatrix, a novel hydrogel platform designed to transform how we grow cells, engineer tissues, and screen new drugs created by CEO Jan Hunik and CTO Matt Baker. Topics discussed: Why traditional flat, 2D cell culture misses the biological mark and what a responsive cell environment really looks like (00:27)The origins of MosaMatrix and the realization that new, adaptive hydrogels were needed for dynamic cell culture (04:45)What makes the MosaMatrix hydrogel different—and why passive scaffolds fall short (06:12)Mechanical and biological characteristics that define hydrogel performance, from stiffness to stress relaxation (07:48)The company's pivot from 3D tissue printing to focusing on high-throughput 3D cell culture for drug discovery (08:42)Advantages of a non-animal-derived, reproducible matrix for research and industry (10:20)Strategies for obtaining real-world customer feedback and working in consortia with academia and industry partners (11:51)Key hurdles in quality control, reproducibility, and measuring success in the emerging field (16:05)Challenges with standardizing organoids and the move to smaller, more automatable culture systems (17:50)The impact of automation and data consistency for scaling up 3D cell culture (18:14)Smart insight: MosaMatrix validates its hydrogel not through internal R&D alone, but through direct collaboration with academic and industry partners — testing performance across cell types and culture media. This includes a ~50-company consortium building next-gen 3D cell culture tools and a new consortium improving kidney dialysis with living human cells. The partnerships surface real variables, like how much culture media composition affects results, that continually shape product development. If this conversation got you thinking about biomaterials, scale-out manufacturing, and what it takes to turn a chemistry breakthrough into a fundable company, these episodes explore the same ground from complementary angles. Episodes 221 - 222: From 2D Cultures to Advanced 3D Cell Models for Preclinical Research with Catarina BritoEpisodes 259 - 260: Why Strong Science Isn't Enough to Get Funded: What Investors Actually Look For with Michael RomeEpisodes 265 - 266: From Human Variability to Automated Precision: Accelerating Cell and Gene Therapy Manufacturing Scale-Out with Farlan VeraitchEpisodes 223 - 224: From Cultivated Meat to Chocolate: Rethinking Cellular Agriculture Scale-Up with Steven LangConnect with Jan Hunik and Matt Baker: Emails: matt.baker@mosamatrix.com and jan.hunik@mosamatrix.comWebsite: www.mosamatrix.comLinkedIn Jan Hunik: www.linkedin.com/in/jan-hunik-0183734LinkedIn Matt Baker: www.linkedin.com/in/matthew-baker-0abb981bSupport 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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