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:

Need fast CMC guidance? New on-demand CMC advisory: Get 20 expert answers/month in 1 day + monthly strategy call. → Learn more: https://stan.store/SmartBiotech/p/ondemand-cmc-expertise-for-biotech-founders

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? Grab our Startup Founder CMC Dashboard in Notion to help you track tasks, timelines, and risks in one place at https://stan.store/SmartBiotech/p/discovertoind-cmc-dashboard-for-startup-founders

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.

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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.

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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

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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

Are you ready to revolutionize your bioprocess development? Join David Brühlmann as he interviews Belma Alispahic, Chief Scientific Officer and Co-Founder of AnalysisMode, who unveils the game-changing potential of AI in biopharma.

Discover how AI is transforming the industry, from drug discovery to manufacturing, and learn why it's no longer optional but essential for success.

Key takeaways:

1. Leverage AI to streamline experiments, reduce costs, and accelerate your path to market
2. Gain insights into emerging AI technologies reshaping biopharma's future
3. Learn practical steps to integrate AI into your workflow, even with limited resources

Don't miss this opportunity to stay ahead of the curve and unlock the full potential of your biotech projects. Tune in now to empower your scientific journey and simplify complex bioprocessing challenges with AI-driven solutions.

Connect with Belma Alispahic:

LinkedIn: https://www.linkedin.com/in/balispahic

Analysis Mode: https://analysismode.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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Is AI the secret weapon biotech scientists have been waiting for? In this eye-opening episode, we dive deep into the world of AI-driven bioprocess development with Belma Alispahic, Chief Scientific Officer and Co-Founder of AnalysisMode. Discover how AI is transforming the biotech landscape, from reducing downtime by 50% to unlocking unprecedented levels of precision in process optimization.

Key takeaways:

1. Learn how AI can slash experiment time by up to 80%, saving you valuable resources
2. Uncover the power of digital twins in fine-tuning your bioprocesses with unparalleled accuracy
3. Gain insights on overcoming data challenges to harness AI's full potential in your lab

Don't miss this game-changing discussion that could revolutionize your approach to bioprocess development. Tune in now and stay ahead of the curve in the rapidly evolving world of biotech!

Connect with Belma Alispahic:

LinkedIn: https://www.linkedin.com/in/balispahic

Analysis Mode: https://analysismode.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 electrifying episode, we dive deep into the future of biotech with biotech influencer Benjamin McLeod. From quantum AI mapping cellular interactions to the game-changing potential of process analytical technology, Ben, who is also a Cell & Gene Therapy Segment Lead at NanoMosaic, unveils how artificial intelligence is set to transform the cell and gene therapy landscape.

Discover why LinkedIn is becoming the new frontier for biotech networking and career advancement. Learn how combining AI with PAT could slash production costs and boost yields in ways you've never imagined.

You will gain invaluable insights on:

1. Leveraging AI to optimize bioprocesses and reduce costs
2. The evolving landscape of viral and non-viral gene therapies
3. Strategies for breaking into the cell and gene therapy field

Don't miss this opportunity to stay ahead of the curve in biotech innovation. Tune in now and revolutionize your approach to bioprocessing!

Connect with Benjamin McLeod:

LinkedIn: https://www.linkedin.com/in/benjamin-mcleod

NanoMosaic: https://www.nanomosaicllc.com

Next Steps:

Wondering how to develop cell and gene therapies with peace of mind? 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? DM us at hello@bruehlmann-consulting.com

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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:

• Continuous vs Fed-Batch Economics Are Closer Than Expected: Andreas reveals real process economic modeling data showing that while continuous reduces capital costs through smaller bioreactors and facilities, higher media consumption (20-25% of COGS) and operational complexity often balance out the savings. The deciding factor isn't technology elegance but your specific production volume and pipeline needs.
• Regulatory Approval Isn't Easier Despite FDA Support: Even with regulatory enthusiasm for continuous processing, QA teams still demand the same fundamentals: traceability, batch definition, viral clearance validation, and process characterization. The technology choice should be driven by your business case, not regulatory preferences.
• Sustainability Benefits Are Modest: Contrary to industry hype, Andreas shares findings showing continuous manufacturing delivers only 20% carbon footprint reduction compared to optimized fed-batch. Real environmental gains come from HVAC efficiency and smaller cleanroom footprints, not inherent process advantages.

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

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

Discover how a failed optometry dream led Benjamin McLeod to become a leading voice in cell and gene therapy. In this eye-opening episode, Ben, who is a Cell & Gene Therapy Segment Lead at NanoMosaic, shares his unconventional path from lab work to LinkedIn stardom, revealing how he bridges the gap between R&D and marketing in biotech.

Learn how Ben's weekly science memes evolved into valuable content that attracts both lab techs and CEOs alike.

Key takeaways:

1. Gain insider tips on communicating complex science effectively
2. Learn how to leverage social media to build industry credibility
3. Discover the power of continuous learning in fast-paced biotech fields

Whether you're a seasoned scientist or biotech enthusiast, this episode offers invaluable insights into the art of scientific communication. Tune in now to transform your approach to biotech development and communicating science.

Connect with Benjamin McLeod:

LinkedIn: https://www.linkedin.com/in/benjamin-mcleod

NanoMosaic: https://www.nanomosaicllc.com

Next Steps:

Wondering how to develop cell and gene therapies with peace of mind? 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? DM us at hello@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

Ever wondered why your perfectly optimized lab process falls apart at industrial scale?

Mass transfer experts Lars Puiman and Rik Volger from the University of Delft reveal the hidden world of oxygen transfer and aeration that can make or break your production.

Dive into the crucial differences between lab-scale and industrial-scale bioreactors, and discover why your DO sensor might be fooling you. Learn how CFD simulations and innovative downscaling techniques can revolutionize your scale-up strategy.

In this episode, you'll gain:

1. Insider tips for predicting and managing concentration gradients in large-scale reactors
2. Cutting-edge methods to measure kLa accurately in industrial settings
3. Strategies to leverage microfluidics for cost-effective process development

From the basics of bubble behavior to the latest in AI and machine learning, this episode is packed with practical insights to enhance your bioprocess efficiency and product quality. Don't miss out on these game-changing mass transfer secrets – tune in now and take your bioprocessing skills to the next level!

Connect with our guests:

Lars Puiman: https://www.linkedin.com/in/larspuiman

Rik Volger:  https://www.linkedin.com/in/rikvolger

Next Step:

Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Additional Resources:

Bubbles and Broth: A review on the impact of broth composition on bubble column bioreactor hydrodynamics

Read the review paper at https://doi.org/10.1016/j.bej.2023.109124

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Unlock the mysteries of oxygen transfer in bioreactors with mass transfer experts Lars Puiman and Rik Volger from the University of Delft. In this eye-opening episode, dive deep into the crucial world of kLa (oxygen mass transfer coefficient) and its impact on bioprocess scale-up.

Discover why understanding kLa is essential for optimizing cell growth and product formation in bioreactors. Learn practical strategies to enhance oxygen transfer, from manipulating bubble size to leveraging unexpected allies like ethanol. Our experts reveal:

1. How to increase mass transfer efficiency without breaking the bank
2. The surprising effects of broth composition on oxygen transfer rates
3. Cutting-edge sparger technologies for optimal aeration

Whether you're a seasoned bioprocess engineer or a curious scientist, this episode will revolutionize your approach to oxygen transfer in bioprocessing.

Don't miss these game-changing insights – tune in now!

Connect with our guests:

Lars Puiman: https://www.linkedin.com/in/larspuiman

Rik Volger:  https://www.linkedin.com/in/rikvolger

Next Step:

Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Additional Resources:

Bubbles and Broth: A review on the impact of broth composition on bubble column bioreactor hydrodynamics

Read the review paper at https://doi.org/10.1016/j.bej.2023.109124

Support the show

Dive into the cutting-edge world of gene therapy as we unravel the complexities of AAV production. In this insightful episode, Ahmed Youssef, a seasoned AAV expert and Senior Process Development Manager at Ascend, explains how you can navigate the complex world of AAV scale-up and learn why thinking outside the box is crucial for success.

Key takeaways:

1. Leverage early expert advice to ensure your therapeutic's long-term viability
2. Explore innovative technologies like doggy bone DNA to reduce impurities
3. Gain insights from industry pioneers to revolutionize your AAV production process

From plasmid alternatives to cutting-edge CDMO strategies, this episode is packed with game-changing information. Don't miss out on these invaluable scale-up secrets that could transform your gene therapy projects.

Tune in now and take your AAV production skills to the next level!

Connect with Ahmed Youssef:

LinkedIn: https://www.linkedin.com/in/ahmed-samir-youssef

Ascend: https://www.ascend-adv.com

Next Steps:

Wondering how to develop cell and gene therapies with peace of mind? 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? DM us at hello@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

Unlock the mysteries of AAV manufacturing in this eye-opening episode! Ahmed, a seasoned AAV expert and Senior Process Development Manager at Ascend, reveals insider strategies for biotech scientists navigating the complex world of gene therapy production.

Discover why quality is the cornerstone of successful AAV development and how to avoid costly missteps in the journey from lab to clinic.

Key takeaways:

1. Learn to design a robust AAV manufacturing process that stands up to regulatory scrutiny
2. Master the art of balancing yield and quality for economically viable production
3. Gain insights into cutting-edge analytical tools that ensure your AAV's efficacy

From cell line selection to plasmid optimization, Ahmed breaks down the critical factors that can make or break your AAV project. Whether you're a biotech novice or a seasoned pro, this episode is packed with actionable advice to elevate your gene therapy game.

Ready to revolutionize your approach to AAV production? Tune in now!

Connect with Ahmed Youssef:

LinkedIn: https://www.linkedin.com/in/ahmed-samir-youssef

Ascend: https://www.ascend-adv.com

Next Steps:

Wondering how to develop cell and gene therapies with peace of mind? 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? DM us at hello@bruehlmann-consulting.com

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Unlock the secret weapon of biotech success! In this eye-opening episode, host David Brühlmann reveals how fractional CTOs are revolutionizing drug development, inspired by Michael Jordan's approach to greatness. Learn how this innovative strategy can slash timelines, mitigate risks, and give your biotech company a competitive edge.

Discover the game-changing benefits of fractional expertise:

1. Gain rapid access to broad biotech knowledge, navigating complex challenges with ease.
2. Slash costs while tapping into C-level strategic guidance for critical growth phases.
3. Accelerate business development through valuable industry connections and insights.

Ready to transform your biotech journey? Tune in to explore how harnessing fractional expertise could be the catalyst your company needs.

Don't miss this opportunity to level up your drug development game – listen now and stay ahead in the fast-paced world of biotech innovation!

Next Steps:

Schedule your free call at https://bruehlmann-consulting.com/assessment to discover how you can develop biologics better, faster, at a fraction of the cost with our Fractional CTO services.

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Unlock the secrets of successful bioprocess development with host David Brühlmann as he shares hard-won lessons from his 15+ years of experience leading technology transfers and technology innovation projects.

Discover why prioritizing process development is crucial for transforming groundbreaking science into life-changing therapies. In this eye-opening episode, you'll learn:

1. How to avoid costly mistakes in technology transfer and scale-up, saving you time and resources
2. Strategies for balancing investor expectations with regulatory hurdles, keeping your project on track
3. Tips for building a robust risk management strategy that impresses investors and navigates challenges

From selecting the right cell lines to mastering the delicate dance of speed and quality, David unveils the hidden pitfalls that can derail even the most promising biotech innovations.

Whether you're a seasoned scientist or a curious entrepreneur, this episode is packed with actionable insights to supercharge your bioprocess development. Don't miss out – tune in now and take your biotech game to the next level!

Next Steps:

Wondering how to develop biologics with peace of mind? 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? DM us at https://bruehlmann-consulting.com

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What if your biomanufacturing facility could run itself, optimize its own processes, and operate non-stop? This isn't science fiction – it's the cutting-edge reality Professor Massimo Morbidelli is helping to create.

In this captivating episode, the bioprocessing pioneer unveils how AI, continuous manufacturing, and revolutionary machine learning techniques are transforming the industry landscape.

As a Professor Emeritus at ETH Zurich and Politecnico di Milano, and a co-founder of ChromaCon (now YMC) and DataHow, Massimo Morbidelli has been at the forefront of bioprocess innovation. He is currently the recipient of the ERC Advanced Grant Continuous Digitalisation of Bioprocesses (CoDiBio) at the Aristotle University of Thessaloniki.

Discover how transfer learning is revolutionizing process development across molecules and scales, dramatically reducing time-to-market for new biologics. Learn why the integration of computer science and biology is crucial for staying competitive in the rapidly evolving biopharma landscape.

You will gain invaluable insights on

1. Slashing development costs,
2. Maximizing productivity through 24/7 operations
3. Leveraging interdisciplinary knowledge to solve complex bioprocessing challenges

All are essential skills for thriving in the next era of biomanufacturing.

Tune in now and revolutionize your approach to biopharma innovation!

Connect with Massimo Morbidelli:

Email: massimo “dot” morbidelli “at” polimi “dot” it

Next Steps:

Wondering how to develop biologics with peace of mind? 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.

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Imagine a world where biologic drugs are produced faster, cheaper, and with unprecedented precision.

In this episode, we dive into that future with Professor Massimo Morbidelli, a trailblazer in bioprocessing innovation. As a Professor Emeritus at ETH Zurich and Politecnico di Milano, and a co-founder of ChromaCon (now YMC) and DataHow, Massimo Morbidelli has been at the forefront of bioprocess innovation. He is currently the recipient of the ERC Advanced Grant Continuous Digitalisation of Bioprocesses (CoDiBio) at the Aristotle University of Thessaloniki.

From his groundbreaking work in continuous chromatography to spearheading AI-driven manufacturing, Morbidelli's 25-year journey has reshaped the biotech landscape.

Discover how initial industry skepticism transformed into widespread adoption of continuous processing and machine learning. Prof. Morbidelli shares insights on his current project: a fully automated, end-to-end manufacturing process for plasmid DNA production.

You will gain invaluable insights into:

1. The evolution of continuous bioprocessing and its impact on productivity and yield
2. How digitalization and machine learning are optimizing process development and manufacturing
3. The potential of transfer learning to dramatically reduce time-to-market for new biologics

Don't miss this opportunity to learn from a true visionary in the field.

Tune in now to unlock the secrets of next-generation biomanufacturing and stay ahead of the curve in this rapidly evolving industry.

Connect with Massimo Morbidelli:

Email: massimo “dot” morbidelli “at” polimi “dot” it

Next Steps:

Wondering how to develop biologics with peace of mind? 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.

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Are your shake flasks holding back your bioprocess development? Discover how to transform them into smart bioreactors! In this game-changing episode, we talk with Jens Bayer about the groundbreaking DOTS platform. He is a deep tech entrepreneur and seasoned commercial leader, currently serving as Chief Commercial Officer at Scientific Bioprocessing.

Jens reveals how this cutting-edge technology is bridging the gap between simple shake flasks and complex bioreactors, offering scientists unprecedented control and data insights.

Learn how to:

1. Generate real-time growth curves and monitor key parameters without invasive sampling
2. Run fed-batch experiments in shake flasks, mimicking bioreactor conditions
3. Optimize your processes for better scalability and reproducibility

Whether you're a startup scientist or working in Big Pharma, this episode will revolutionize your approach to early-stage bioprocessing. Don't miss Jens' invaluable tips for designing successful shake flask experiments and his inspiring journey as a biotech entrepreneur.

Ready to supercharge your bioprocess development? Tune in now and unlock the hidden potential of your shake flasks!

Connect with Jens Bayer:

LinkedIn: https://www.linkedin.com/in/jens-bayer-65a46350

Scientific Bioprocessing: https://www.scientificbio.com

Next Steps:

Wondering how to develop biologics with peace of mind? 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? 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.

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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:

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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Are shake flasks outdated relics or untapped goldmines of bioprocess development? In this eye-opening episode, we dive deep with Jens Bayer, a deep tech entrepreneur and seasoned commercial leader, currently serving as Chief Commercial Officer at Scientific Bioprocessing.

Jens shatters common misconceptions about shake flasks, revealing why they remain indispensable tools in both industry and research settings.

Discover:

1. Why shake flasks are irreplaceable for rapid, cost-effective experimentation
2. How to overcome the "black box" challenge and extract crucial data
3. Strategies to optimize shake flask processes for better scalability

From startups to Big Pharma, learn how mastering shake flask techniques can accelerate your bioprocess development and save precious resources. Whether you're a seasoned biotech pro or just starting out, this episode will transform how you approach early-stage bioprocessing.

Ready to revolutionize your lab work? Tune in now and unlock the hidden potential of shake flasks!

Connect with Jens Bayer:

LinkedIn: https://www.linkedin.com/in/jens-bayer-65a46350

Scientific Bioprocessing: https://www.scientificbio.com

Next Steps:

Wondering how to develop biologics with peace of mind? 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? DM us at https://bruehlmann-consulting.com

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Dive into the cutting-edge world of autologous cell-based therapy with Deana Mohr, CEO and co-founder of MUVON Therapeutics, spin-off from the University of Zurich. In this eye-opening episode, discover how MUVON Therapeutics’ innovative approach to muscle regeneration is revolutionizing treatments for stress urinary incontinence and beyond.

Learn how her team is tackling the challenges of bringing personalized medicine to market at scale, from navigating complex regulations to automating production processes.

Listeners will gain invaluable insights on:

1. Strategies for engaging with regulatory bodies to advance novel therapies
2. The crucial role of automation in making cell therapies accessible and affordable
3. Building successful partnerships to accelerate biotech innovation

Whether you're a scientist, investor, or healthcare professional, this episode offers a fascinating glimpse into the future of regenerative medicine. Tune in to explore how Deana's vision of "copy-paste" therapy production could transform millions of lives and reshape the biotech landscape!

Connect with Deana Mohr:

LinkedIn: https://www.linkedin.com/in/deana-mohr-haralampieva-95a9a5a4

MUVON Therapeutics: https://www.muvon-therapeutics.com

Next Steps:

Wondering how to develop cell and gene therapies with peace of mind? 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? DM us at hello@bruehlmann-consulting.com

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Discover how scientists are transforming lives through innovative muscle regeneration therapy. In this captivating episode, Deana Mohr, CEO and co-founder of MUVON Therapeutics, spin-off from the University of Zurich, unveils her groundbreaking autologous muscle regeneration technology for treating stress urinary incontinence.

Learn how this minimally invasive treatment harnesses the power of a patient's own cells to restore muscle function, offering hope to millions. Diana shares her journey from PhD research to clinical trials, revealing the challenges of translating cutting-edge science into real-world treatments.

Listeners will gain insights on:

1. The potential of autologous muscle tissue regeneration and the hurdles of medical innovation.
2. Navigating the complex path from lab to clinic
3. Key differences between muscle-based and CAR-T cell therapies

Whether you're a scientist, investor, or simply curious about medical innovations, this episode offers a fascinating glimpse into the future of regenerative medicine. Tune in to explore the forefront of biotech entrepreneurship!

Connect with Deana Mohr:

LinkedIn: https://www.linkedin.com/in/deana-mohr-haralampieva-95a9a5a4

MUVON Therapeutics: https://www.muvon-therapeutics.com

Next Steps:

Wondering how to develop cell and gene therapies with peace of mind? 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? DM us at hello@bruehlmann-consulting.com

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Ever wondered why some biotech facilities thrive while others struggle Alfredo Martínez Mogarra, a Bioprocess Engineer with over 30 years of experience and Chief Operations Manager at VIVEbiotech, reveals the secrets to successful biotech manufacturing.

In this eye-opening episode, Alfredo shares critical insights on bridging the gap between lab-scale processes and industrial production.

You will get:

1. Strategies for seamless scale-up and risk mitigation in bioprocess development
2. Tips for fostering crucial interdepartmental collaboration in biotech facilities
3. Guidance on leveraging automation and AI for enhanced process control and predictability

Whether you're a biotech scientist, engineer, or industry professional, this episode is packed with invaluable wisdom to elevate your facility design and operations.

Don't miss Alfredo's golden rule: "Think very well before starting doing things." Tune in now and learn how to build a foundation for biotech success!

Connect with Alfredo Martínez Mogarra:

LinkedIn: https://www.linkedin.com/in/alfredo-martínez-mogarra-a381087

Biotech Academy in Rome: https://www.biotechacademy.eu

Next Steps:

Wondering how to develop biologics with peace of mind? 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? DM us at https://bruehlmann-consulting.com

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Ever wondered what it takes to build a large-scale biotech manufacturing facility? Alfredo Martínez Mogarra, a seasoned Bioprocess Engineer with over 30 years of experience and Chief Operations Manager at VIVEbiotech, reveals the secrets behind successful biotech facility design and scale-up. He has been at the forefront of transforming bench processes into industrial realities.

In this eye-opening episode, Alfredo shares critical insights on navigating the complex world of biotech manufacturing. Listeners will gain:

1. A deep understanding of the key factors in designing efficient biotech facilities
2. Strategies to mitigate risks when scaling up processes
3. Tips for fostering successful interdisciplinary collaboration

Whether you're a biotech scientist, engineer, or industry professional, this episode is packed with invaluable wisdom to elevate your bioprocessing game.

Tune in now and learn how to think holistically about biotech facility design.

Connect with Alfredo Martínez Mogarra:

LinkedIn: https://www.linkedin.com/in/alfredo-martínez-mogarra-a381087

Biotech Academy in Rome: https://www.biotechacademy.eu

Next Steps:

Wondering how to develop biologics with peace of mind? 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? 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

Unlock the secrets of cell factories and discover how cutting-edge technologies are revolutionizing biopharmaceutical production. In this episode, we welcome Mauro Torres, a postdoctoral researcher at the University of Manchester, who takes us on a fascinating journey through the complex world of protein manufacturing.

Mauro Torres explains the intricate steps involved in the secretory pathway, from gene expression to protein export, likening it to a sophisticated car manufacturing process. He then delves into how omics technologies and systems-level approaches are enhancing our understanding of cell physiology and improving production effectiveness.

Listeners will gain valuable insights into:

1. The potential of AI and machine learning to navigate vast amounts of bioprocess data
2. How synthetic biology is creating cells with new functionalities and improved adaptability
3. The exciting future of biopharmaceutical production as technologies converge

Discover how these advancements are paving the way for more predictable, affordable, and robust medicine production, promising a brighter future for patients worldwide.

Connect with Mauro Torres:

Linkedin: https://www.linkedin.com/in/mauro-torres-seb

Next Steps:

Book a free assessment to help you develop biologics with peace of mind: https://bruehlmann-consulting.com

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Unlock the secrets of cell factories with Mauro Torres, a postdoctoral researcher at the University of Manchester who brings cutting-edge insights into protein production. Discover how the concept of cell factories has evolved from basic insulin extraction to groundbreaking treatments for genetic disorders and cancer. We reveal the challenges faced by biotech scientists in bioprocess development and offers a fascinating analogy between car manufacturing and cellular protein assembly.

Learn how recent advancements in synthetic biology, genetic editing, and AI-driven process optimization are transforming the biopharmaceutical industry. From transposon technology to microfluidics and hybrid modeling, We explore the game-changing innovations that are accelerating cell line development and enhancing protein secretion.

Gain valuable insights into:

1. The evolution of cell factories
2. Cutting-edge technologies revolutionizing bioprocessing
3. Strategies for reprogramming cells for enhanced protein production

Don't miss this episode packed with expert knowledge on the future of biomanufacturing.

Connect with Mauro Torres:

Linkedin: https://www.linkedin.com/in/mauro-torres-seb

Next Steps:

Book a free assessment to help you develop biologics with peace of mind: https://bruehlmann-consulting.com

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Curious about the latest innovations in cell analysis technology? Join us in this episode with Furkan Gökçe, New Business Development Manager at Amphasys, as we delve into the fascinating world of Impedance Flow Cytometry (IFC).

Furkan shares how IFC is revolutionizing single-cell analysis by providing faster, more precise, and high-resolution data.

Key Takeaways:

1. Real-Time Precision: Discover how IFC allows for real-time, label-free assessments of cells, providing detailed insights into their natural state.
2. Enhanced Process Control: Learn how IFC can detect early signs of nutrient deficiencies and contaminants, leading to timely interventions and improved bioreactor outcomes.
3. Versatile Applications: Hear about practical applications, from brewing to protein production, where IFC has significantly boosted yields and process efficiency.

Tune in to uncover how IFC is set to transform the landscape of bioprocessing, ensuring better quality and sustainability in biologics production.

Connect with Furkan Gökçe:

LinkedIn: https://www.linkedin.com/in/furkangokce

Amphasys: https://amphasys.com/bioprocessing

Next Steps:

Book a free assessment to help you get started with the implementation of new technologies in your manufacturing processes: https://bruehlmann-consulting.com

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@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.

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Ever wondered how single-cell analysis could revolutionize bioprocessing? Join us in this episode as we delve into the cutting-edge world of impedance flow cytometry.

Furkan Gökçe, New Business Development Manager at Amphasys, shares his insights on the transformative power of this technology in the biotech industry. With a background in engineering and physics, Furkan provides a unique perspective on tackling the complexities of biological systems.

Key Takeaways:

1. Enhanced Process Control: Learn how impedance flow cytometry offers high-resolution, label-free analysis of individual cells, ensuring optimal growth conditions and quality production.
2. Understanding Cell Heterogeneity: Discover the importance of single-cell analysis in revealing critical variations within cell populations that bulk measurements often miss.
3. Innovation in Bioprocessing: Explore the advancements in microfabrication techniques that make real-time, high-throughput cell analysis possible, revolutionizing bioprocessing efficiency and accuracy.

Tune in to gain valuable knowledge on how this innovative technology can enhance your bioprocess development and manufacturing strategies!

Connect with Furkan Gökçe:

LinkedIn: https://www.linkedin.com/in/furkangokce

Amphasys: https://amphasys.com/bioprocessing

Next Steps:

Book a free assessment to help you get started with the implementation of new technologies in your manufacturing processes: https://bruehlmann-consulting.com

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

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Dive into the transformative world of bead-based assays with Sebastian Giehring, CEO and founder of PAIA Biotech, where high-throughput screening meets cutting-edge biotechnological advancements.

Join us as we chat with Sebastian, a seasoned scientist and entrepreneur who has revolutionized the workflow of high-throughput screening of titer, glycosylation, and aggregation with innovative bead-based assays.

Key Takeaways:

1. Streamlined Workflow: Learn how a simplified sample prep can enhance efficiency and accuracy in glycosylation and aggregation screenings.
2. Optimized Experiment Design: Discover the critical do's and don'ts in designing robust experiments that yield meaningful results.
3. Future of Screening: Explore how AI and machine learning are set to revolutionize the biotechnological landscape, driving better drug development and process optimization.

Tune in to uncover how these insights can transform your lab's capabilities and drive groundbreaking discoveries!

Connect with Sebastian Giehring:

LinkedIn: https://www.linkedin.com/in/sebastian-giehring-6ba1992

PAIA Biotech: https://www.paiabio.com

Next Steps:

Book a free assessment to help you get started with the design of your next experiment at https://bruehlmann-consulting.com

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

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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:

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.

Support the show

Ready to revolutionize your lab work? Join us as we dive deep into bead-based assays with Sebastian Giehring, CEO and founder of PAIA Biotech.

Discover how these tiny beads are making a massive impact on biotech research and development — for titer, glycan, and aggreation screening — and how this developability screening platform can enhance your antibody discovery, antibody engineering and lead optimization.

In this episode, you’ll learn:

1. Speed and Simplicity: How bead-based assays offer unmatched throughput and ease of use, allowing you to analyze hundreds of samples in just a few steps.
2. Versatile Applications: The diverse applications of bead-based assays in cell development, bioprocessing, and antibody discovery, helping streamline workflows and enhance innovation.
3. Early Screening Advantages: The benefits of bead-based assays in early-stage process development, enabling quick decision-making with less detailed but rapid results.

Tune in to uncover how these assays can transform your biotech research and push the boundaries of what's possible!

Connect with Sebastian Giehring:

LinkedIn: https://www.linkedin.com/in/sebastian-giehring-6ba1992

PAIA Biotech: https://www.paiabio.com

Next Steps:

Book a free assessment to help you get started with the design of your next experiment at https://bruehlmann-consulting.com

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

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How do small biotech companies make strategic decisions with limited resources? This episode dives deep into the art of prioritization and outsourcing to achieve success.

Join us as we speak with Mark Melville, Vice President of CMC, Biologics at Cullinan Therapeutics, a seasoned biotech scientist with years of experience in both large and small biotech companies. Mark shares his invaluable insights on navigating the complexities of bioprocess development and outsourcing.

In this episode, we explore:

1. Discover the secrets to prioritizing projects for maximum impact
2. Leverage outsourcing for flexibility and expertise
3. Learn to build strong relationships with external vendors to ensure top-notch quality and regulatory compliance.

Connect with Mark Melville:

LinkedIn: https://www.linkedin.com/in/mark-melville-a9a43b2

Next Steps:

Wondering how to develop biologics with peace of mind? 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? DM us at https://bruehlmann-consulting.com

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Are you navigating the complex world of bioprocess CMC development and manufacturing in a small biotech company?

Our latest episode is a must-listen! Join us as we sit down with Mark Melville, Vice President of CMC, Biologics at Cullinan Therapeutics, who shares invaluable insights on overcoming the unique challenges faced by small biotech firms.

In this episode, we explore:

1. The critical communication strategies needed for successful outsourcing to CDMOs.
2. How small biotechs can leverage their agility to make fast, impactful decisions.
3. The surprising benefits of wearing multiple hats and fostering cross-functional expertise.

Tune in to discover how mastering these areas can help your small biotech thrive and stay ahead in a competitive market.

Don't miss this opportunity to gain practical advice and turn your challenges into advantages!

Connect with Mark Melville:

LinkedIn: https://www.linkedin.com/in/mark-melville-a9a43b2

Next Steps:

Wondering how to develop biologics with peace of mind? 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? DM us at https://bruehlmann-consulting.com

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In this insightful episode, we explore the cutting-edge field of glycoengineering and its transformative impact on biopharmaceutical drug design. Join us as we chat with Róisín O’Flaherty, Assistant Professor in the Department of Chemistry at Maynooth University, to uncover the nuances of chemoenzymatic glycogen engineering and its potential to revolutionize therapeutics.

Key Takeaways:

1. Understanding Glycoengineering: Discover the three main approaches—genetic, metabolomic, and chemoenzymatic—for modifying glycosylation and enhancing drug properties.
2. Real-World Applications: Learn how industry giants are leveraging glycoengineering to innovate cancer treatments and other therapies.
3. Future of Glycoanalytics: Explore how AI and machine learning are poised to further advance the precision and efficiency of glycoengineering.

Don't miss this deep dive into how glycoanalytics is paving the way for more effective and personalized biopharmaceutical drugs. Tune in to understand the future of drug design and the exciting possibilities it holds.

Connect with Róisín O’Flaherty:

LinkedIn: https://www.linkedin.com/in/roisin-o-flaherty-a67a2b8a

Twitter: https://x.com/irishglycogirl

Next Steps:

Book a free assessment to help you get started with glycoanalytics and glycoengineering at https://bruehlmann-consulting.com

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

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Uncover the hidden science behind creating safer, more effective biological drugs! Dive into glycoanalytics and glycoengineering, the secret weapons revolutionizing biopharma.

Join us as we talk with Róisín O’Flaherty, Assistant Professor in the Department of Chemistry at Maynooth University, who breaks down the complexities of glycosylation and its pivotal role in drug development.

Key Takeaways:

1. Critical Quality Attributes: Understand how glycans influence the function and structure of biopharmaceutical products, enhancing their efficacy and safety.
2. Analytical Techniques: Learn about the three major approaches—native glycoprotein analysis, glycopeptide analysis, and released glycan analysis—each providing unique insights into glycosylation.
3. Future Trends: Discover how automation, AI, and advanced mass spectrometry are revolutionizing glycoanalytics, making it more accessible and precise.

Tune in to explore how glycoanalytics is driving the next generation of safer, more effective biopharmaceuticals!

Connect with Róisín O’Flaherty:

LinkedIn: https://www.linkedin.com/in/roisin-o-flaherty-a67a2b8a

Twitter: https://x.com/irishglycogirl

Next Steps:

Book a free assessment to help you get started with glycoanalytics and glycoengineering at https://bruehlmann-consulting.com

Develop biologics better, faster, at a fraction of the cost with our Fractional CTO services. Curious? DM us at hello@bruehlmann-consulting.com

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Join us as we explore the pivotal role of process mapping in biotech knowledge management. Our guest, Irwin Hirsh, a seasoned biotech consultant concentrating on enhancing business efficiency and effectiveness, shares invaluable insights into leveraging technology to streamline operations.

Key Insights:

1. Identifying Critical Process Knowledge: Learn strategies to identify and manage vital process knowledge essential for optimal performance.
2. Transitioning from Implicit to Explicit Knowledge: Discover why converting hidden, tribal wisdom into structured, accessible information is crucial for scalability and continuity.
3. Harnessing Digital Tools: Explore effective approaches to digital transformation, ensuring seamless integration and collaboration across teams and time zones.

Join us as Irwin uncovers actionable steps to enhance efficiency and innovation in biotech through strategic process mapping.

Connect with Irwin Hirsh:

LinkedIn: https://www.linkedin.com/in/ishirsh

Q-Specialists AB: https://www.qspecialists.com

Next Steps:

Wondering how to develop biologics and cell & gene therapies with peace of mind? 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? 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.

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Want to turn your biotech chaos into streamlined success? Learn from expert Irwin Hirsh, a seasoned biotech consultant concentrating on enhancing business efficiency and effectiveness, on how process mapping can transform your knowledge management and elevate your business performance.

Key Takeaways:

1. Eliminate Scope Creep: Learn how to maintain focus in projects despite shifts and changes, improving productivity and reducing frustration.
2. Bridge Experience Gaps: Understand how process mapping creates a common language, enabling seamless knowledge transfer between seasoned experts and newcomers.
3. Enhance Systematic Approach: Discover the power of standardization and continuous improvement to boost overall business performance.

Tune in to uncover practical strategies that can transform your knowledge management practices and drive your biotech endeavors to new heights.

Connect with Irwin Hirsh:

LinkedIn: https://www.linkedin.com/in/ishirsh

Q-Specialists AB: https://www.qspecialists.com

Next Steps:

Wondering how to develop biologics and cell & gene therapies with peace of mind? 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? DM us at https://bruehlmann-consulting.com

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Get ready to dive into the fascinating world of cryopreservation!

In this episode, we welcome Mark Davison, an experienced entrepreneur and CEO of Grant Instruments, leaders in laboratory equipment, to explore the intricate science of freezing and thawing cells.

Mark brings his wealth of experience to demystify this crucial process, revealing how cutting-edge technology ensures precision and reliability in preserving biological samples.

Key Takeaways:

1. Mastering Precision: Learn how data acquisition and controlled rate freezing are essential to maintaining the integrity of your samples.
2. Technological Advancements: Discover the latest innovations transforming laboratory practices, from analog to digital conversions to remote monitoring.
3. Entrepreneurial Insights: Gain valuable advice on leveraging support systems and cultivating a collaborative culture to succeed in scientific entrepreneurship.

Tune in for an insightful conversation that blends technical expertise with practical advice, perfect for scientists and entrepreneurs alike!

Connect with Mark Davison:

LinkedIn: https://www.linkedin.com/in/markdavison100

The Big Experiment podcast: https://thebigexperiment.buzzsprout.com

Grant Instruments: https://www.grantinstruments.com

Next Steps:

Wondering how to develop biologics and cell & gene therapies with peace of mind? 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? DM us at https://bruehlmann-consulting.com

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Picture a world where we can freeze cells and bring them back to life perfectly intact.

In this episode, we're joined by Mark Davison, a leading expert in cryopreservation and CEO of Grant Instruments to uncover the intricate science of freezing and thawing cells. From basic principles to advanced techniques, we delve into how cryopreservation is revolutionizing biotechnology and cell therapies.

Key Takeaways:

1. Cell Survival Secrets: Discover why water is both a friend and foe in preserving cell viability, and how precise control over freezing rates can prevent cell damage.
2. Advanced Techniques: Learn about cutting-edge technologies that ensure safe and effective cryopreservation, minimizing risks associated with traditional methods like liquid nitrogen.
3. Automation in Cryopreservation: Understand the future of lab workflows with automation, reducing human error and increasing reproducibility in cell-based experiments.

Tune in to explore how cryopreservation is shaping the future of biotech!

Connect with Mark Davison:

LinkedIn: https://www.linkedin.com/in/markdavison100

The Big Experiment podcast: https://thebigexperiment.buzzsprout.com

Grant Instruments: https://www.grantinstruments.com

Next Steps:

Wondering how to develop biologics and cell & gene therapies with peace of mind? 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? 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.

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Could sound waves be the revolutionary key to gene therapy manufacturing? In this episode, Gabriel Dumy, CTO and Co-founder at Kolibri, reveals how acoustic waves are set to transform cell harvesting and gene transfection processes, making biomanufacturing more efficient and less damaging to cells.

Kolibri is a company revolutionizing the way we grow and engineer cells at scale using acoustic waves.

Key Takeaways:

1. Real-Time Cell Harvesting: Discover how reconfigurable acoustic waves enable non-damaging, precise cell harvesting without the need for harsh chemicals.
2. Enhanced Gene Transfection: Learn about breakthrough methods to make cell membranes more permeable, dramatically improving the efficiency of gene delivery.
3. Scalable Bioproduction: Understand the scalable potential of acoustic waves in bioreactors, offering innovative solutions for complex tissue engineering and fragile cell growth.

Join us to explore how these advancements could revolutionize the future of gene therapy and beyond!

Connect with Gabriel Dumy

LinkedIn: https://www.linkedin.com/in/gabrieldumy

Kolibri: https://www.kolibrilab.com

Next Steps:

Wondering how to develop biologics and cell & gene therapies with peace of mind? 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? DM us at https://bruehlmann-consulting.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:

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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Are sound waves the key to revolutionizing gene therapy? In this groundbreaking episode, we sit down with Gabriel Dumy, CTO and Co-founder at Kolibri, a company revolutionizing the way we grow and engineer cells at scale using acoustic waves.

Gabriel shares the challenges facing modern bioproduction and unveils an exciting solution that's setting the stage for the future of gene therapy.

Key Takeaways:

1. Enhanced Cell Productivity: Discover how acoustic waves minimize shear stress, significantly boosting mammalian cell productivity and density.
2. Versatile Bioreactor Design: Learn about a cell-agnostic technology that seamlessly adapts to various cell lines, simplifying process development.
3. Scalable Innovation: Understand the potential of this scalable tech to maintain consistent microenvironments, paving the way for large-scale gene therapy production.

Tune in to find out how acoustic waves could be the breakthrough gene therapy has been waiting for!

Connect with Gabriel Dumy

LinkedIn: https://www.linkedin.com/in/gabrieldumy

Kolibri: https://www.kolibrilab.com

Next Steps:

Wondering how to develop biologics and cell & gene therapies with peace of mind? 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? 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

Dive into the future of bioprocessing with Nils Brechmann, Marketing Manager at MAGic BioProcessing and co-inventor of the process applications, as we explore how magnetic bead technology is transforming downstream processing.

MAGic BioProcessing is a biotech company from Uppsala, Sweden, that develops magnetic-based recovery of biologicals.

Key Takeaways:

1. Streamlined Purification: Discover how magnetic beads enable simultaneous clarification and capture, boosting efficiency.
2. Cost Savings: Learn about significant cost reductions by integrating steps and improving process economics.
3. Scalable Solutions: Understand the potential for large-scale applications, making magnetic bead technology a versatile option for biomanufacturing.

Join us for an in-depth look at the benefits and innovations of magnetic bead technology in modern bioprocessing.

Connect with Nils Brechmann:

LinkedIn: https://www.linkedin.com/in/nils-brechmann-ph-d-44205114a

MAGic BioProcessing: https://magicbioprocessing.com

Next Step:

Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

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Dive into the latest episode as we explore how magnetic bead technology is revolutionizing downstream processing, promising higher yields and greater purity.

Our guest, Nils Brechmann, Marketing Manager at MAGic BioProcessing and co-inventor of the process applications, shares his insights on overcoming industry challenges and the future of purification. MAGic BioProcessing is a biotech company from Uppsala, Sweden, that develops magnetic-based recovery of biologicals.

Key Takeaways:

1. Discover how magnetic beads integrate cell clarification and capture, reducing processing steps and mechanical stress.
2. Learn about the remarkable efficiency of magnetic beads in achieving low Host Cell Protein (HCP) levels right from the start.
3. Understand the economic benefits of this technology, from cost savings to increased throughput in large-scale facilities.

Ready to elevate your bioprocessing game? Tune in now and harness the power of magnetic bead technology.

Connect with Nils Brechmann:

LinkedIn: https://www.linkedin.com/in/nils-brechmann-ph-d-44205114a

MAGic BioProcessing: https://magicbioprocessing.com

Next Step:

Enhance your bioprocess development strategy! Schedule your free assessment to propel your success: https://bruehlmann-consulting.com/assessment

Support the show