Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders – Details, episodes & analysis

Finding an analytical CRO that's truly invested in your success, not just processing samples, makes all the difference in CMC development. In this episode, host David Brühlmann talks with Daniel Galbraith, Chief Scientific Officer at Solvias, about the essential questions and mindset that lead to breakthrough CRO partnerships.

With nearly three decades in analytical development, spanning monoclonal antibodies, biosimilars, and cell and gene therapies, Daniel reveals what separates CROs who become true partners from those who just run methods. His insights can save your program months of delays and costly missteps.

Key Topics Discussed:

• Why cell and gene therapies face unique challenges compared to the progression seen with monoclonal antibodies (03:04)
• Daniel’s career path: from entering biotech in 1996 to CSO at Solvias, and the rapid evolution of the industry (05:00)
• The analytical hurdles in characterizing cell-based products and how their inherent variability impacts development (09:46)
• Approaches to analytical method requirements for autologous cell therapies, and how data is gathered iteratively in these cases (13:02)
• The biggest obstacles to scaling up cell and gene therapies, and why innovative cell manipulation technologies are needed (16:06)
• Current trends in therapeutic modalities: why antibody-drug conjugates stand out, and whether mRNA therapies are losing momentum (18:37)
• Practical advice on choosing an analytical CRO as a strategic partner - what to look for, what questions to ask, and why enthusiasm and standardization matter (21:55)

Wondering how to streamline your own analytical strategy, or navigate the parallel universe of cell and gene therapy development? Dig into this episode for Daniel’s insider perspective. Then consider how the right analytical partnership could accelerate your path to clinic.

Connect with Daniel Galbraith:

LinkedIn: www.linkedin.com/in/daniel-galbraith-26a6138

Solvias website: www.solvias.com

Email: daniel.galbraith@solvias.com

Next steps:

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Book a 20-minute call to help you get started on any questions you may have about bioprocessing analytics: https://bruehlmann-consulting.com/call

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One bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.

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What if the answer to battling antibiotic-resistant infections isn’t a new antibiotic, but harnessing viruses that have been quietly dominating bacterial populations?

Bacteriophages, viruses that target and kill bacteria, have been saving lives for a century, but their true potential is only now being unlocked by modern machine learning. The race isn’t just about discovering effective phages; it’s about deploying the right therapy, personalized to the patient, before time runs out.

On this episode, David Brühlmann welcomes José Luis Bila, Co-Founder and CEO of Precise Health. Driven by personal tragedy and an engineer’s mindset, José is shaping a future where AI-powered phage therapy isn’t a niche solution, but a scalable, accessible weapon against the superbugs that evade antibiotics. From building bioreactor capacity to navigating regulatory gray zones, José brings a rare blend of technical vision and practical urgency to a problem that affects families and health systems worldwide.

Key topics discussed:

• The challenge of evolving bacteria and phages, and the question of whether it’s possible to keep up with nature’s pace through engineering new phages in silico (00:00)
• Overview of bacteriophage production: complexity, types of bioreactors used, and comparison with chemical synthesis (02:54)
• Bioproduction logistics: using CDMOs vs. in-house hospital production and the real-world timescales for manufacturing (02:32)
• Barriers for smaller or less funded hospitals, especially in low- and middle-income countries, with thoughts on hospital infrastructure differences worldwide (04:41)
• Creative solutions for cost-effective phage production in remote and underserved regions, such as the potential for single-use or mobile bioreactors (06:01)
• Why downstream processing and ensuring product purity is a bottleneck; the need for miniaturization and economic scalability (06:40)
• Parallels and differences in downstream processing between bacteriophages and viral vectors (09:15)
• The vital role of stability and shelf life for phage therapy logistics and economic viability (09:15)
• Regulatory pathways for phage therapy in Europe and beyond, including magistral preparations, ethical approvals, and adapting to digital tools for selection (12:39)
• The future vision: routine clinic entry through matching existing phage libraries, with longer-term goals of engineering bespoke phages via AI when necessary (15:52)
• José’s perspective on building global infrastructure and making phage therapy cost-effective and universally accessible (18:08)

José Bila’s message: solutions to antimicrobial resistance are within reach. The biotech community must build accessible infrastructure, using AI and innovative systems to ensure phage therapy benefits reach every patient, everywhere.

Connect with José Luis Bila:

LinkedIn: www.linkedin.com/in/josé-luis-bila-phd-3b08a5a7

Precise Health SA: www.precisehealth.io

Interested in how scientists are fighting superbugs? Learn how phage therapy and smart bioprocess design are helping outmaneuver drug-resistant pathogens. Check out this interview with one of our previous guests!

Episodes 187-188: From Biology Is Messy to Designable: The Smart Bioprocessing Transformation with Carmen Jungo Rhême

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

One bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.

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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:

• Viral Vectors Demystified: Lucas breaks down a common misconception: viral vectors aren’t malignant viruses, but genetically disarmed delivery vehicles that can’t revert or replicate, making them safe tools for gene therapy.
• Manufacturing Mayhem Made Manageable: Unlike monoclonal antibodies and other biologics, viral vectors (and other cell and gene therapies) are made in living cells, leading to a level of process unpredictability and complexity where “everything, everywhere, all at once” applies. Success hinges on scientific acumen and attention to even the smallest detail, from raw materials to equipment parameters, to ensure patient safety and product quality.
• Pioneering in Uncharted Territory: Moving from London to Singapore, Lucas faced not just technical but regulatory and logistical challenges to founding Asia-Pacific’s first CDMO dedicated to viral vectors. His advice: engage regulators early, leverage local biomanufacturing strengths, and build multidisciplinary teams to transfer and scale bioprocess know-how.

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

One bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.

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In this insightful episode, we're joined by Sigma Mostafa, Chief Scientific Officer at KBI Biopharma, who shares crucial insights on selecting the right CDMO partner for biotech development.

Sigma brings a unique blend of scientific rigor and practical experience to the discussion, having worked on both sides of the CDMO relationship.

Key Takeaways:

• Why harvest steps deserve more attention in bioprocess development
• The truth about one-stop-shop CDMOs versus specialized partners
• Critical factors in cell line and media selection that impact long-term success

Sigma emphasizes that successful CDMO partnerships hinge on transparent communication and cultural alignment, not just technical capabilities. She reveals that while one-stop shops seem convenient, partnering with specialized CDMOs who excel in specific areas often yields better results - as long as there's strong project coordination.

Whether you're a startup navigating your first CDMO relationship or an established biotech company looking to optimize your partnerships, this episode provides actionable insights for making informed decisions that will impact your project's success for years to come.

Listen now to transform your approach to CDMO selection and avoid costly pitfalls in your bioprocess development journey.

Connect with Sigma Mostafa:

Linkedin: https://www.linkedin.com/in/sigma-mostafa-79180817

KBI: https://www.kbibiopharma.com

Next Steps:

Wondering how to fast-track bioprocess CMC development? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics at a fraction of the cost with our Fractional CTO services. Curious? DM us at https://bruehlmann-consulting.com

One bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.

Support the show

Struggling to unravel the complexities of your bioprocess? Prepare for a paradigm shift as we dive into the world of Process Analytical Technology (PAT) with Katharina Dahlmann who is Application and PAT Expert at Hamilton.

This eye-opening episode dissects how PAT is redefining biologics manufacturing, balancing its immense potential against real-world implementation hurdles. Katharina navigates us through the intricate journey of scaling up, from micro-bioreactors to large-scale bioreactors, unveiling the hidden gems of early PAT adoption. Whether you're a startup scientist or a seasoned biotech veteran, this episode is packed with insights to elevate your bioprocessing game.

Tune in to uncover:

1. Strategies for overcoming PAT implementation challenges
2. Expert tips on scaling up your processes with confidence
3. A fresh perspective on cross-disciplinary collaboration in biotech

Don't let bioprocess complexity hold you back – listen now and harness the power of PAT to decode your processes like never before!

Connect with Katharina Dahlmann:

LinkedIn: https://www.linkedin.com/in/dr-katharina-dahlmann-616790180

Hamilton: https://www.hamiltoncompany.com

Next Steps:

Wondering how to develop biologics with clarity and precision? Schedule your free consultation to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Contact us at https://bruehlmann-consulting.com

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Unlock the hidden potential of your bioprocess! In this eye-opening episode, David Brühlmann sits down with Katharina Dahlmann, Application and PAT Expert at Hamilton, to explore the game-changing world of Process Analytical Technology (PAT).

Discover how PAT is revolutionizing biotech by providing unprecedented insights into cell behavior and process dynamics. Katharina challenges conventional wisdom, revealing that what we think we know about our processes may just be the tip of the iceberg. Learn how combining multiple PAT signals can extract meaningful knowledge, leading to more reproducible and efficient processes.

You will gain valuable insights on:

1. Leveraging PAT to optimize feeding strategies and reduce process time
2. Balancing inline and offline measurements for comprehensive process understanding
3. The future of PAT, including self-evaluating sensors and data modeling

Ready to take your bioprocessing game to the next level? Tune in now and transform your approach to bioprocess monitoring and control!

Connect with Katharina Dahlmann:

LinkedIn: https://www.linkedin.com/in/dr-katharina-dahlmann-616790180

Hamilton: https://www.hamiltoncompany.com

Next Steps:

Wondering how to develop biologics with clarity and precision? Schedule your free consultation to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Contact us at https://bruehlmann-consulting.com

One bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.

Support the show

Imagine predicting your bioprocess outcomes as easily as checking the weather forecast. Sound impossible? Not anymore. In this insightful episode, we dive deep into the world of digital twins and process models with Fabian Feidl, co-founder and CTO of DataHow.

Discover how these cutting-edge tools are reshaping the biotech landscape, from simplifying complex processes to enabling personalized medicine. Fabian shares invaluable insights on implementing data-driven approaches, even for smaller companies with limited resources.

Key takeaways:

1. Learn how to start small and build powerful process models that drive real results
2. Discover the game-changing potential of combining AI with bioprocess expertise
3. Explore the future of personalized medicine through advanced data analytics

Ready to revolutionize your biotech workflow? Tune in now and unlock the secrets to smarter, more efficient bioprocessing!

Connect with Fabian Feidl:

LinkedIn: https://www.linkedin.com/in/fabian-feidl-a52b36b3

DataHow: https://datahow.ch

Next Steps:

Wondering how to develop biologics with clarity and precision? Schedule your free consultation to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Contact us at https://bruehlmann-consulting.com

Support the show

Are you ready to decode the future of bioprocessing? In this eye-opening episode, we dive deep into the world of digital bioprocess development with Fabian Feidl, co-founder and CTO of DataHow.

Discover how cutting-edge process models are transforming the biotech industry, bridging the gap between raw data and actionable insights.

Key takeaways:

1. Learn how process models can streamline development, reduce costs, and accelerate time-to-market for groundbreaking therapies.
2. Explore the game-changing potential of personalized medicine through predictive modeling in CAR T-cell therapy.
3. Uncover strategies to overcome organizational and technological barriers in adopting digital technologies for bioprocessing.

From optimizing experimental design to enabling data-driven decision-making, this episode is packed with invaluable insights for biotech scientists and leaders. Tune in now to unlock the future of bioprocessing and take your research to the next level!

Connect with Fabian Feidl:

LinkedIn: https://www.linkedin.com/in/fabian-feidl-a52b36b3

DataHow: https://datahow.ch

Next Steps:

Wondering how to develop biologics with clarity and precision? Schedule your free consultation to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Contact us at https://bruehlmann-consulting.com

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Are you ready to dive into the cutting-edge world of biomanufacturing? In this episode, strategic consultant James Ryall unveils the staggering potential of bio-based products to revolutionize industries. From cultured meat to human breast milk, discover how cells are becoming the ultimate manufacturing facilities.

James shares invaluable insights on scaling challenges, regulatory hurdles, and the critical importance of early preparation for biotech startups. Learn why biomanufacturing is poised to transform up to 60% of consumer goods and how to stay ahead in this rapidly evolving field.

Gain expert strategies to:

1. Navigate scaling and regulatory challenges with confidence
2. Create bio-based products that outperform traditional alternatives
3. Tap into the immense opportunities in non-clinical biomanufacturing

Whether you're a seasoned bioprocessing expert or a curious entrepreneur, this episode will ignite your passion for the biotech revolution. Tune in now and discover how to ride the wave of biomanufacturing innovation!

Connect with James Ryall:

LinkedIn: https://www.linkedin.com/in/james-ryall

Website: https://www.jamesryall.com

Next Steps:

Wondering how to develop biologics with clarity and precision? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Contact us at https://bruehlmann-consulting.com

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In this captivating episode, host David Brühlmann welcomes James Ryall, a strategic consultant with over two decades of experience in cell biology and regenerative medicine. From his groundbreaking work in skeletal muscle research to revolutionizing cultured meat production, James shares his fascinating journey through academia and industry.

Discover how he's now helping biotech startups align their technical strategies with commercial outcomes, accelerating their path to market.

You will gain invaluable insights on:

1. Navigating the transition from academia to industry
2. Scaling cell production from lab quantities to industrial volumes
3. Identifying and pivoting to the right target market for biotech innovations

Don't miss this eye-opening discussion on simplifying bioprocessing and bringing game-changing products to life. Tune in now to supercharge your biotech career!

Connect with James Ryall:

LinkedIn: https://www.linkedin.com/in/james-ryall

Website: https://www.jamesryall.com

Next Steps:

Wondering how to develop biologics with clarity and precision? Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? Contact us at https://bruehlmann-consulting.com

One bad CDMO decision can cost you two years and your Series A. If you're navigating tech transfer, CDMO selection, or IND prep, let's talk before it gets expensive. Two slots open this month.

Support the show