Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders

What if the answer to solid tumor therapy isn’t about making immune cells smarter—but about rethinking what a therapeutic cell can do For years, mesenchymal stem cells (MSCs) have turned heads for their ability to home in on damaged tissue, yet their clinical utility has lagged behind the hype. What would it take to transform MSCs from passive healers into precision vehicles for next-generation cancer treatment?
This week, David Brühlmann sits down with Jun Yung Woo, Co-Founder of AGEM Bio, who’s devoted nearly two decades to decoding and reimagining the potential of MSCs. From engineering stress-resilient cells to pioneering dual-payload therapeutic platforms, Jun Yung Woo bridges fundamental biology and real-world clinical translation.
Topics discussed:
The case for understanding cell biology before focusing on process scale-up in bioprocessing (02:38)
Jun Yung Woo's personal and scientific journey toward developing engineered MSC therapeutics (04:36)
How MSCs sense their environment and exert therapeutic effects via secreted factors, rather than tissue replacement (08:28)
Key differences between MSC therapies and immune cell therapies like CAR T cells (10:35)
Overview of non-viral engineering platforms, and the importance of intracellular trafficking for modifying MSCs (12:23)
Design of AGEM Bio's dual-payload MSC product (cytosine deaminase and interferon beta) to induce highly localized tumor stress and immune activation (14:10)
Strategies for controlling MSC targeting and minimizing off-target effects, including the use of prodrug activation and localized cell delivery (17:23)
Study results from treating companion animals with engineered MSCs, and observations of tumor regression and possible signs of immune memory (20:29)
Open questions about the durability of antitumor responses and future directions for clinical research (22:34)
Smart insight: Jun Yung Woo challenges the rush toward bioprocess scale-up, arguing that a deeper understanding of cellular biology should come before manufacturing cells at scale. This episode explores how scaling the wrong biology can derail entire therapeutic platforms—and why aligning process development with cellular function may be critical for clinical success.
These episodes expand on the same themes of MSC biology, cell engineering, and the challenges of scaling consistent, functional cell therapies:
Episodes 179 - 180 : How Mesenchymal Stromal Cells Are Transforming Care for Diabetes and Autoimmune Diseases with Lindsay Davies
Episodes 253 - 254: How to Source, Manufacture, and Scale the Earliest Stem Cells for Allogeneic Cell Therapy Without Ethical Barriers with Yuta Lee
Episodes 125 - 126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei
Episodes 129 - 130: Revolutionizing Cell Therapy Manufacturing: Reducing Costs to Reach More Patients with Jason Foster
Connect with Jun Yung Woo:
LinkedIn: www.linkedin.com/in/junyungwoo
AGEM Bio website: www.agem.bio
Email: yung@agem.bio
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Why does life-saving insulin cost hundreds of dollars a month for patients, when manufacturing costs are just a fraction of that price? What if the nonprofit model could change everything for affordable access?
In the pharmaceutical industry, affordability and access remain two of the biggest hurdles for patients, especially when the economics of essential medicines seem stacked against them.
Eric Moyal, founder of Project Insulin, is rewriting the rules of biosimilar development. Coming from a fundraising and nonprofit background rather than the pharma inside track, Eric built Project Insulin not to chase profits, but to deliver an essential therapy at a price real people can afford.
Topics covered:
Key differences between nonprofit and for-profit models in biotech, especially around fundraising, incentives, and revenue (00:02)
The intricate balance between development costs, operating expenses, and setting an affordable price point (00:06)
Innovative distribution models to eliminate price inflation by middlemen, including direct-to-patient and clinic partnerships (00:08)
Major roadblocks in reinventing drug distribution and the importance of building the right partnerships early on (00:10)
Advice for founders and scientists exploring solutions to drug affordability, including corporate structure, fundraising, and perseverance (00:12)
Lessons learned after five years building Project Insulin, emphasizing the value of assembling the right team and listening to feedback (00:13)
Realistic expectations for Project Insulin’s next five years and the primary goals on the horizon (00:16)
The broader need for affordable generic drugs and the broken promise of the current patent system (00:17)
How to connect with Project Insulin and support its mission (00:18)
Smart insight: Generic medicines should be affordable. Ensuring low-cost, accessible generics is essential to restoring the original balance between pharmaceutical innovation and public access, and it requires collective effort beyond any single player.
If you enjoyed this episode, you might want to listen to these within a broader set of discussions on biologics affordability, CMC strategy, and bioprocessing realities — from the economic barriers blocking patient access and regulatory decision-making for biosimilars, to CDMO selection for resource-constrained teams:
Episode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them)
Episodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias Müllner
Episodes 103 - 104: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma Mostafa
Connect with Eric Moyal:
Email: emoyal@projectinsulin.org
Website: www.projectinsulin.org
Instagram: www.instagram.com/projectinsulin
LinkedIn: www.linkedin.com/company/82500193
TikTok: www.tiktok.com/@project.insulin
YouTube: www.youtube.com/@ProjectInsulin
Next step: If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode.
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Insulin was first discovered over a century ago—yet in the United States, 1 in 5 insulin-dependent patients still ration their lifesaving supply. Why is a molecule so essential, and so well understood, still so out of reach for so many?
Eric Moyal, founder of Project Insulin, decided to challenge not just the science, but the business model itself. With a background in nonprofit fundraising—not drug development—he’s building a biosimilar insulin glargine and promising to sell it directly to patients at cost, insurance or not.
Topics discussed include:
The origins of the insulin affordability crisis and the impact of profit-driven healthcare systems (04:27)
How over a million Americans are forced to ration their insulin every month, and the broader impact on patients’ (lives 06:37)
The advantages and challenges of approaching drug development with a background outside of biotech (08:37)
The fundraising-focused strategy for overcoming scientific and technical hurdles in developing biosimilar insulin (09:17)
Technical details on Project Insulin’s development process, including selection of CDMOs, importance of analytical data, and process challenges like reverse-phase cleaving and crystallization (11:16)
The impact of recent FDA regulatory changes on the development and approval pathway for biosimilars in the U.S. (15:45)
Smart insight: A nonprofit approach to essential medicines could reshape the future for patients who depend on them. By removing shareholder expectations and focusing on affordability and access, leaders like Eric Moyal are proving new paths are possible—not through incremental science alone, but through bold re-imaginings of how science serves the public.
If you enjoyed this episode, you might want to listen to these within a broader set of discussions on biologics affordability, CMC strategy, and bioprocessing realities — from the economic barriers blocking patient access and regulatory decision-making for biosimilars, to CDMO selection for resource-constrained teams:
Episode 136: 5 Roadblocks to Affordable Biologics (And How to Overcome Them)
Episodes 57 - 58: Crafting a Solid CMC Strategy: Key Factors and Common Pitfalls with Matthias Müllner
Episodes 103 - 104: One-Stop Shop vs. Specialist CDMO: A Scientist's Guide to CDMO Selection with Sigma Mostafa
Connect with Eric Moyal:
Email: emoyal@projectinsulin.org
Website: www.projectinsulin.org
Instagram: www.instagram.com/projectinsulin
LinkedIn: www.linkedin.com/company/82500193
TikTok: www.tiktok.com/@project.insulin
YouTube: www.youtube.com/@ProjectInsulin
Next step: If you enjoyed this episode, please leave a review on Apple Podcasts or your favorite podcast platform. By doing so, we can empower more scientists like you. Stay tuned for more inspiring biotech insights in our next episode.
Support the show

The cell and gene therapy industry faces massive hurdles—cost, scalability, and the need for highly skilled operators have historically limited the reach of these transformative treatments. advanced therapy medicinal products manufacturing innovation is urgently needed to overcome these challenges and unlock broader global access.
Farlan Veraitch, founder and Chief Scientific Officer at Ori Biotech, is leading the way in reimagining manufacturing platforms using automation, modularity, and digital transformation. His vision is redefining how cell and gene therapies are produced—from research labs to point-of-care hospital settings.
What’s inside:
The use and adaptation of the paper pull tab sterile connection system—miniaturized and multiplexed—to ensure reliable material transfer in the manufacturing process (06:36)
How modular and stackable system design supports scale-up and scale-out, increasing manufacturing capacity and flexibility (09:17)
Full digitization of the Ori platform, including setting up digital twins, integrating sample prep automation, and capturing data for QA/QC in real time (10:11)
Deskilling bioprocess operations, reducing the need for highly trained cell culture staff, and enabling broader use in both centralized facilities and hospitals (14:02)
The logistical benefits of separating material prep (like buffer and virus formulation) from the manufacturing site to streamline point-of-care applications (15:39)
Farlan’s vision for an accessible, profitable, globally distributed manufacturing platform to support new treatment pipelines (17:14)
Driving down cost and improving scalability as key challenges to unlocking the potential of cell and gene therapies (18:49)
Strategic insight:
The cell and gene therapy field needs to lower manufacturing costs and increase production. Focused, practical approaches are required to make these life-changing therapies more efficient, scalable, and accessible to more patients around the world.
Listen for practical perspectives on automation, digital tools, manufacturing infrastructure, and the future possibilities for decentralized, scalable cell and gene therapy production.
Connect with Farlan Veraitch:
LinkedIn: www.linkedin.com/in/farlan-singh-veraitch-a677112
Email: farlan.veraitch@oribiotech.com
Ori Biotech: www.oribiotech.com
Next step:
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What if the simple act of opening an incubator could undermine the consistency of your cell therapy manufacturing process? Unlike traditional biologics, the moment cells leave their incubator, subtle shifts in temperature, CO₂, and pH can spiral into mission-critical variability, jeopardizing everything from product yield to therapeutic potency.
This episode features Farlan Veraitch, founder and Chief Scientific Officer of Ori Biotech. Trained at UCL’s Department of Biochemical Engineering, Farlan blends a bioprocess engineer’s mindset with hands-on experience scaling monoclonal antibodies, before pioneering the first-ever automation platform for embryonic stem cell culture. His drive for eliminating variability and designing systems that scale seamlessly from bench to bedside has informed ORI’s approach to modular cell therapy manufacturing.
What you’ll hear in this episode:
The importance of controlling pH, temperature, and shear forces in cell therapy manufacturing (00:36)
Lessons learned from scaling monoclonal antibody production and its impact on biotech business models (05:23)
The unique sources of variability in primary and stem cells, and why automation is essential (11:16)
Strategies to minimize human-induced variability in sensitive cell cultures (12:59)
How exposure to ambient oxygen and CO₂ during manual processing affects cell viability (14:13)
The logic behind Ori Biotech’s modular design to solve environmental control issues (19:04)
Strategic insight:
As cell and gene therapies push boundaries, manufacturing must keep pace with exponentially tighter requirements. Farlan’s journey highlights a universal lesson for scientists and engineers: process control is not just a technicality, but a necessity for reproducible, scalable, and commercially viable therapies.
If you’re grappling with process variability or looking for fresh strategies in cell and gene therapy development, this episode offers an inside view from a scientist who’s worked at the intersection of bioprocess, automation, and commercial translation.
Connect with Farlan Veraitch:
LinkedIn: www.linkedin.com/in/farlan-singh-veraitch-a677112
Email: farlan.veraitch@oribiotech.com
Ori Biotech: www.oribiotech.com
Next step:
Need fast CMC guidance? → Get rapid CMC decision support here
Support the show