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What if the future of affordable, life-changing cell and gene therapies comes down to one critical yet often overlooked factor: manufacturing efficiency?
In advanced therapy medicinal products (ATMPs), groundbreaking science abounds, but the path to the clinic is still strewn with bottlenecks, especially when it comes to cost, complexity, and safety. While the promise is enormous, most therapies remain out of reach for many patients due to high cost of goods and logistical hurdles. What can actually break down these barriers and democratize access?
In this episode, David Brühlmann welcomes Lucas Chan, celebrated Fellow of the Royal Society of Biology, advisor to Singapore's Ministry of Health, and a true pioneer in viral vector manufacturing. In Singapore, he founded CellVec Pte Ltd – APAC’s first regulatory accredited Viral Vector specialist CDMO.
Lucas's leadership spans founding ventures in emerging markets to championing game-changing innovations in gene transfer, always with an eye toward efficiency, safety, and accessibility. Having returned “back to the bench” in collaboration with the National University of Singapore while launching his consultancy, Lucas brings both visionary perspective and hands-on experience to one of biotech’s toughest challenges.
Here are three reasons why you need to listen to this episode:
Want to transform your approach to cell and gene therapy manufacturing or just need inspiration to push your biotech project to the next level?
Tune into this episode for practical insights, candid leadership lessons, and a renewed sense of what’s possible when we challenge the status quo together.
Connect with Lucas Chan:
LinkedIn: www.linkedin.com/in/lucaschangt
Next step:
Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call
Preparing for your IND? We’re building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105
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
Viral vectors are the backbone of cutting-edge cell and gene therapies, delivering life-altering treatments to patients with genetic diseases. But making these biological delivery vehicles is a high-wire act: unpredictable, complex, and fraught with hurdles that traditional biologics manufacturers have never faced.
While the world races toward next-generation therapies, the challenge of producing viral vectors at clinical and commercial scale threatens to leave patients waiting on the sidelines.
Our guest on the Smart Biotech Scientist Podcast is Lucas Chan, a molecular and cell biologist with over two decades of hands-on experience in cell and gene therapy development. From his formative research at Imperial College London, where he pioneered novel viral vector cell lines, to building the UK’s first GMP clinical viral vector core and later founding CellVec Pte Ltd Asia Pacific CDMO in Singapore, Lucas is the go-to architect for manufacturing viral vectors where infrastructure barely exists.
Along the way, he’s faced and overcome challenges few others could imagine.
Here are three reasons this episode is a must-listen:
Curious how viral vector manufacturing can be reimagined to unlock the full promise of cell and gene therapies? Listen to this episode and gain unique insights into the science, strategy, and sheer determination needed to bring advanced therapies out of the lab and into the clinic.
Connect with Lucas Chan:
LinkedIn: www.linkedin.com/in/lucaschangt
Next step:
Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call
Preparing for your IND? We’re building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105
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
Is continuous manufacturing delivering the transformative results everyone promised, or are you being sold an expensive solution to the wrong problem? While industry headlines tout revolutionary productivity gains, the economic reality behind continuous bioprocessing tells a more nuanced story that every process engineer needs to understand before making capital investment decisions.
In this episode, host David Brühlmann continues his conversation with Andreas Castan, Strategic Technology and Business Development Leader at Cytiva, diving deep into the hard economics and operational realities of next-generation manufacturing strategies. Andreas brings over 25 years of bioprocess expertise from upstream innovation to cGMP manufacturing scale-up.
Here are three critical takeaways from this conversation:
Ready to cut through the marketing noise and make data-driven manufacturing decisions? This conversation delivers the unvarnished truth about when continuous processing creates real value and when intensified fed-batch might be your smartest investment.
Connect with Andreas Castan:
LinkedIn: www.linkedin.com/in/andreas-castan-91570b1
Cytiva landing page: Process intensification
Online tool: Process intensifier
Next step:
Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call
Preparing for your IND? We’re building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105
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
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:
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:
Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call
Preparing for your IND? We’re building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105
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
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:
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:
Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call
Preparing for your IND? We’re building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105
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
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 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:
Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call
Preparing for your IND? We’re building a CMC Dashboard in Excel to help biotech founders track tasks, timelines, and risks in one place. Join the waitlist for early access at https://scale-your-impact.notion.site/27dd9c6ba679804b80a7ce439d56c91a?pvs=105
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
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:
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 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call
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
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:
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 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call
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
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:
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:
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.
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
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:
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:
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.
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
From the publisher's feed
The go-to CMC and biomanufacturing podcast for bioprocess development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and…
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:
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: [email protected]

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