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

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. Secure your assessment 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:

🧬 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

Support the show

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

Support the show

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

Support the show