What if process intensification could transform your bioprocessing economics without the complexity most engineers fear? Getting 3x productivity gains and 30-150% titer increases once seemed reserved for Big Pharma's endless R&D budgets, but a strategic approach to technology selection is making these results achievable for companies of any size.

In this episode, David Brühlmann speaks with Andreas Castan, a bioprocess veteran with over 25 years of industry experience who provides leadership and support to Cytiva's bioprocess business. Andreas brings deep expertise from directing upstream development at Swedish Orphan Biovitrum and extensive work in expression systems, process development, scale-up, and cGMP manufacturing across multiple therapeutic modalities.

Why tune in? Here's your process engineer's roadmap:

• Process Intensification Economics Decoded: Andreas reveals the cost-benefit reality behind continuous vs fed-batch manufacturing, including real process economic modeling data showing why the differences aren't as dramatic as you'd expect and what factors actually drive your business case.
• Low-Hanging Fruit That Delivers: Skip the overhyped AI solutions. Andreas shares the strategic fundamentals that work: high-producing cell line development, N-1 perfusion for rapid productivity gains, and smart bioreactor turndown strategies that eliminate process steps without adding complexity.
• Decision Framework for Technology Selection: Learn when continuous processing makes economic sense (and when it doesn't), how media costs impact your COGS analysis, and why understanding your bottlenecks, not following industry trends, should drive your intensification strategy.
• Industry Insider Strategies: Get the inside track on what AstraZeneca, Sanofi, Merck, Lonza, and Takeda are actually implementing, plus Andreas's perspective on why human expertise and mechanistic insights still outweigh AI in real-world process decisions.

Ready to make smarter technology investments and achieve measurable productivity gains? This isn't theory. It's a practical guide to process intensification economics that you can apply whether you're preparing for Phase I or scaling for commercial manufacturing.

Connect with Andreas Castan:

LinkedIn: www.linkedin.com/in/andreas-castan-91570b1

Cytiva landing page: Process intensification

Online tool: Process intensifier

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🧬 Stop second-guessing your CMC strategy. Our fast-track CMC roadmap assessment identifies critical gaps that could derail your timelines and gives you the clarity to build a submission package that regulators approve. Secure your assessment at https://stan.store/SmartBiotech/p/get-cmc-clarity-in-1-week--investor-ready

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Still think you can "figure out CMC later"? Your competitors just implemented a systematic framework that cuts their IND timeline in half while you're still debating whether CMC matters.

The founders who file INDs predictably aren't smarter than you. They just stopped gambling with ad-hoc CMC approaches and started executing proven systems. While you're wrestling with technical details in crisis mode, they built systematic advantages that turn regulatory complexity into competitive weapons.

In this episode, host David Brühlmann delivers the complete five-step framework that transforms CMC from startup-killer into market advantage. This isn't theory. These are the exact systematic approaches helping founders file INDs in 10-12 months while competitors struggle with preventable delays.

The strategic reality: Systematic CMC isn't about becoming a technical expert. It's about becoming strategically smart about expert partnerships and execution frameworks. Smart founders focus on "WHO not HOW," building the right team while maintaining strategic control.

Three key takeaways that will transform your approach:

• Start Early, Think Strategically: Early, deliberate CMC planning isn't just for big pharma. Linking your product's clinical goals to quality, process, and regulatory milestones from day one eliminates expensive delays later. Smart founders build systematic CMC advantages while competitors treat it as an afterthought.
• Quality by Design as Competitive Weapon: Pinpointing critical quality attributes and mapping them to real patient outcomes creates scientific credibility that accelerates every downstream decision. This isn't regulatory box-checking. This is building the foundation that impresses investors, satisfies regulators, and prevents costly manufacturing surprises.
• Systematic Risk Management as Submission Insurance: A living, well-documented risk register can be the difference between confident IND filing and regulatory rejection. Poor risk tracking is cited by FDA and EMA as a recurring deficiency that leads to clinical holds and expensive delays. Don't become the cautionary tale.

This five-step framework creates predictable execution that transforms CMC from crisis management into strategic capability. Instead of reacting to problems, you prevent them. Rather than scrambling under pressure, you scale smoothly from development to commercialization.

Ready to bring structure and confidence to your own CMC program? Explore David’s CMC dashboard via the link below , and catch his walkthrough to see the system in action.

Solid CMC execution starts with the right conversation.

Next step:

🧬 Stop second-guessing your CMC strategy before investor meetings. Our 1-Week CMC Assessment reveals your roadmap gaps and transforms uncertain founders into confident presenters who ace investor meetings. Only 5 spots available monthly. Claim yours at https://stan.store/SmartBiotech/p/get-cmc-clarity-in-1-week--investor-ready

❗️De-risk CMC development and get decision-making guidance with a new AI platform that transforms CMC overwhelm into predictable development success (launching early 2026). Join the waitlist here: https://david-jkhjdoje.scoreapp.com

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Think you can crack the science first and worry about CMC when you "need it"? That's exactly how promising therapies die in regulatory limbo while patients keep waiting.

Your breakthrough discovery means nothing if it's trapped in CMC chaos. While you're perfecting your molecular mechanism, competitors with inferior science but superior CMC strategy are racing past you to IND filing and ultimately, to patients.

In this episode, I, David Brühlmann, your usual host, expose the dangerous delusion that's quietly bankrupting biotech startups: the belief that brilliant science automatically translates to successful drug development. Drawing from years of watching founders burn through millions because they treated CMC as an afterthought, I reveal why the smartest scientific minds often make the most catastrophic business decisions.

Here's the hard truth you'll confront in this episode:

• The $50M Misconception: Why "CMC is just manufacturing" thinking destroys companies before they ever reach Phase II. While you're debating molecular targets, smart founders are building systematic CMC advantages that compress timelines and slash costs. The FDA doesn't care how elegant your science is if you can't demonstrate consistent, scalable manufacturing.
• The Brutal Mathematics of Delay: Systematic CMC approach: 10-12 months to IND, 85% hit timelines. "Figure it out later" approach: 15 months or more, and a much lower success rate. Every month you delay isn't just burning cash. If your therapy could help 10,000 patients annually, that's 833 people per month who don't get treatment because of preventable delays.
• Three Founder Myths That Kill Programs: The misconceptions about CMC being "basically just manufacturing," bringing in experts "when we need them," and CDMOs handling "the complicated stuff." Each myth leads to the same outcome: brilliant science trapped by business incompetence.
• Your Four-Action Emergency Protocol: Stop hoping CMC will work out. Start implementing systematic approaches. I give you four specific actions to execute this week, not someday when you're "ready," but right now while you can still prevent the crisis that kills 40% of biotech programs.

The competitive reality: While you're listening to this episode, your biggest competitor just moved closer to IND filing. Maybe they completed process validation. Maybe they locked in analytical methods. The question isn't whether CMC matters. It's whether you'll master it before your competitors do.

Next step:

❗️De-risk CMC development and get decision-making guidance with a new AI platform that transforms CMC overwhelm into predictable development success (launching early 2026). Join the waitlist here: https://david-jkhjdoje.scoreapp.com

🧬 Stop second-guessing your CMC strategy before investor meetings. Our 1-Week CMC Assessment reveals your roadmap gaps and transforms uncertain founders into confident presenters who ace investor meetings. Secure your assessment at https://stan.store/SmartBiotech/p/get-cmc-clarity-in-1-week--investor-ready

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For too long, biotech innovators have viewed biological systems as inherently messy, unpredictable, and full of “black box” mysteries. But what if, armed with the latest digital tools, AI, and cross-disciplinary thinking, you could transform bioprocessing from a series of trial-and-error experiments to a streamlined, proactive design process?

Carmen Jungo Rhême is Full Professor at the University of Applied Sciences in Fribourg (HEIA-FR) and Director of the Biofactory Competence Center (BCC). With 17 years in the pharmaceutical industry at companies like Lonza, Merck Serono, UCB Farchim, and CSL Behring, she specializes in bioprocess development, protein purification, scale-up, and technology transfer. Since joining HEIA-FR in late 2023, she has launched research projects tackling antimicrobial resistance, sustainable food production, and bioprocess digitalization.

Here are three reasons why this episode is a must-listen:

• A Blueprint for Scalable Bioprocessing: Carmen reveals the structured, four-phase approach the BCC uses to help startups and established companies alike, from feasibility and risk assessment, to scalable process design, tailored analytics, and seamless tech transfer to GMP manufacturing.
• The Future-Proof Skill Set: Discover why data management, digital tool adaptability, and systems thinking are non-negotiable skills for biotech professionals in the next five years and how both newcomers and seasoned scientists can level up.
• Bioprocessing as Design, Not Chaos: Learn how shifting your mindset from reactive to proactive, and from “biology is messy” to “biology is designable,” can unlock robust processes, faster innovation, and truly sustainable solutions.

Ready to smarten up your biotech game? Listen in as Carmen and David unpack practical, actionable strategies for mastering modern bioprocessing—no matter your starting point.

Connect with Carmen Jungo Rhême:

LinkedIn: www.linkedin.com/in/carmenjungo

Website: www.heia-fr.ch/en/applied-research/bcc/

Next step:

Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call

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Almost every corner of modern medicine and sustainable food production today is facing a massive challenge: how do we outpace drug-resistant “superbugs” and create food for a growing population using fewer resources? The answer, it turns out, may come down to how well we understand and control the biomanufacturing processes underpinning these biomaterials and biomolecules.

In this episode, David Brühlmann speaks with Carmen Jungo Rhême, Full Professor at the University of Applied Sciences in Fribourg, Switzerland and Director of the Biofactory Competence Center. With years in the pharmaceutical industry at Lonza, Merck Serono, UCB Farchim, and CSL Behring, she now tackles global challenges like antimicrobial resistance, sustainable food, and digitalization. From her beginnings in chemical engineering at EPFL to leading at the nexus of academia and industry, Carmen is helping shape the future of smarter, more robust biotech.

Here are three reasons why this episode is a must-listen:

• Antimicrobial Resistance - Smarter Solutions: Carmen explains how phage therapy, recombinant proteins like endolysins, and smart bioprocess design are helping outmanoeuvre drug-resistant pathogens. In partnership with the University Hospital in Lausanne, her team is developing GMP-ready phage production using quality-by-design methods from mainstream recombinant protein manufacturing, bringing phages back into clinical relevance.
• From Cheese Whey to Microalgae: Applying pharma-grade principles to food, BCC is turning Swiss cheese by-products into nutrient-rich microalgae, offering a new path for sustainable protein and lipid production while transforming food waste into valuable resources.
• Digitalization - The Connecting Thread: Mapping and controlling hundreds of process parameters is key to robust, reproducible innovation. Carmen shows how data-driven process characterization links antimicrobial strategies and sustainable food production through the power of digital analytics.

Curious about how smarter bioprocesses could help you solve tomorrow’s biggest biotech challenges? Tune in to hear how Carmen’s approach could transform your perspective on both health and food security.

Connect with Carmen Jungo Rhême:

LinkedIn: www.linkedin.com/in/carmenjungo

Website: www.heia-fr.ch/en/applied-research/bcc/

Next step:

Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call

🧬 Stop second-guessing your CMC strategy before investor meetings. Our 1-Week CMC Assessment reveals your roadmap gaps and transforms uncertain founders into confident presenters who ace investor meetings. Secure your assessment at https://stan.store/SmartBiotech/p/get-cmc-clarity-in-1-week--investor-ready

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Imagine unlocking a world where designing custom proteins is not only feasible - but faster, smarter, and more powerful than ever before, thanks to artificial intelligence.

As the promise of programmable biology takes center stage, AI-driven protein engineering is rapidly moving from theoretical dream to industry standard.

In this episode, David Brühlmann sits down with Elise de Reus, co-founder of Cradle, whose ground-breaking platform has become a go-to for luminaries at pharma giants, as well as leaders in agriculture and industrial biotech. Elise’s journey bridges hands-on scientific discovery with entrepreneurial vision, and she’s on a mission to make biology a foundational pillar of a more sustainable and equitable world.

Here are three reasons you can’t miss this episode:

• AI Unmasks the Black Box: Elise explains how Cradle’s platform isn’t just about predictive power - it offers transparency and actionable insights, allowing scientists to see why models perform as they do, and how to interpret and trust their outputs.
• From Hype to Real-World Impact: You’ll hear real examples of AI accelerating everything from pandemic preparedness and antivenom development, to sustainable raw materials - plus candid advice on scaling AI adoption across diverse project teams.
• Blueprints for Biotech Founders: Elise shares hard-won lessons on transforming scientific innovation into a thriving company, including the counterintuitive power of targeting “mission impossible” challenges and the priceless value of early, unfiltered feedback.

Ready to future-proof your protein engineering with generative AI? Press play to take home Elise’s practical framework for evaluating tools, overcoming organizational hurdles, and crafting a winning adoption strategy, before the innovation curve pulls away.

Wondering how Generative AI is transforming the biotech landscape? From accelerating regulatory workflows to reinventing protein purification, AI is driving breakthroughs across the industry. Explore these standout episodes to hear from experts leading the charge:

• Episodes 77-78: Cell Factories Explained: How Synthetic Biology and AI Revolutionize Protein Production with Mauro Torres
• Episodes 119-120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian Guo
• Episodes 123-124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan Sharfstein
• Episodes 167-168: How Generative AI Is Revolutionizing Biotech Regulatory Compliance with Abhijeet Satwekar

Connect with Elise de Reus:

LinkedIn: www.linkedin.com/in/elise-de-reus-77b83a24

Website: www.cradle.bio

Next step:

Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call

🧬 Ready to eliminate CMC chaos and hit your IND timeline with absolute certainty? Get the complete Notion CMC Dashboard at https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-founders - the proven roadmap that's guided successful mAb programs to hit their IND submission deadlines.

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For decades, protein design has hinged on painstaking rounds of wet lab mutagenesis and trial-and-error, a process limited not by human ingenuity, but by time and complexity. Yet as the biotech field seeks faster, greener, and more effective solutions for therapeutics and industrial applications, the next leap might not come solely from the lab bench.

In this episode, host David Brühlmann explores the frontiers of AI-driven protein engineering with Elise de Reus, co-founder of Cradle. Elise’s journey weaves together a passion for DNA, real-world impact from the dairy industry to synthetic biology, and high-throughput experience at Zymergen. Now, at the helm of Cradle, she is bridging cutting-edge computational models with experimental validation, making biology programmable and accelerating the path from idea to functional protein.

Here are three reasons this episode is essential listening:

• AI Makes Biology Programmable: Generative AI platforms like Cradle can intelligently design protein variants by learning from evolutionary trends and your own project data, enabling smarter, faster iterations and optimizing for stability, activity, and manufacturability - simultaneously.
• Limited Data? No Problem: While traditional approaches have stumbled over small, “short and fat” datasets, new generative AI models can effectively update their understanding with as little as a 96-well plate per round, democratizing high-impact protein design for startups, academia, and industry alike.
• The Future is Human + Machine: Even as algorithms advance, Elise stresses the irreplaceable value of wet lab validation. Cradle’s hybrid approach, integrating experimental feedback with algorithmic prediction, ensures reliable, scalable results and empowers multidisciplinary teams to unlock first- and best-in-class solutions.

Want to see how you can leverage AI to simplify and accelerate your own protein engineering projects? Don’t miss this episode to hear how Elise and Cradle are transforming the pace - and possibilities - of biotech.

Curious how Generative AI is reshaping biotech? From streamlining regulatory compliance to transforming protein purification, AI is changing the game. Dive into these standout episodes to explore the cutting edge of innovation in biotech:

• Episodes 77-78: Cell Factories Explained: How Synthetic Biology and AI Revolutionize Protein Production with Mauro Torres
• Episodes 119-120: Innovating Protein Purification Using Synthetic Organelles and AI with Haotian Guo
• Episodes 123-124: Manufacturability: Why Most Protein Candidates Fail (And How to Pick Winners Early) with Susan Sharfstein
• Episodes 167-168: How Generative AI Is Revolutionizing Biotech Regulatory Compliance with Abhijeet Satwekar

Connect with Elise de Reus:

LinkedIn: www.linkedin.com/in/elise-de-reus-77b83a24

Website: www.cradle.bio

Next step:

Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call

🧬 Ready to eliminate CMC chaos and hit your IND timeline with absolute certainty? Get the complete Notion CMC Dashboard at https://stan.store/SmartBiotech/p/cmc-dashboard-for-biotech-founders - the proven roadmap that's guided successful mAb programs to hit their IND submission deadlines.

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What’s the secret to turning a cutting-edge scientific breakthrough into a commercial biotech success?

For every inspiring lab discovery, countless prototypes stall before ever reaching the market. The barriers? Securing the right beta testers, outmanoeuvring industry giants, and building teams who understand not just the science, but the user experience from bench to bedside.

In this episode of the Smart Biotech Scientist Podcast, David Brühlmann welcomes Chervee Ho, CEO & Co-Founder of BioChromatographix International. Chervee isn’t just developing breakthrough column technologies - she’s navigating the trenches of commercialization, from resource-stretched startups to partnering with risk-averse manufacturers. With hands-on experience turning innovative science into robust data and real-world adoption, Chervee shares candid lessons from her journey building a biotech company from the ground up.

Here are three reasons you can’t miss this episode:

• From Lab Bench to Market: Learn why finding the right beta testing partner is less about luck and more about networking, shared goals, and mutual resource investment - and why a methodical, step-by-step approach beats wishful thinking every time.
• Winning Against the Big Players: Discover how niche focus, third-party validation, and scientific partnership allow startups like BioChromatographix International to carve out space - even when competing against chromatography industry giants.
• The Human Factor: Chervee reveals why startup success is all about mindset - resilience, adaptability, and startup “muscle” - far more than specific credentials. If you want to build a team ready for the marathon of commercialization, don’t miss these culture insights.

Ready to level up your biotech commercialization strategy? Tune in and hear how to accelerate your technology from concept to clinic - without losing focus, funds, or your sanity.

Connect with Chervee Ho:

LinkedIn: www.linkedin.com/in/cherveeho

Website: www.biochromatographix.com

Next step:

Book a free consultation to help you get started on any questions you may have about bioprocess development: https://bruehlmann-consulting.com/call

🧬 Speaking of innovative tools to solve bioprocess development challenges, we're building an AI platform that transforms CMC overwhelm into predictable development success (launching early 2026). Join the waitlist here: https://david-jkhjdoje.scoreapp.com

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