Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
The go-to CMC and biomanufacturing podcast for bioprocess development scientists and CMC leaders scaling biologics into regulatory-ready therapies with less trial and error.
Practical, execution-focused, and strategic guidance on CMC development, tech transfer, scale-up, GMP readiness, CDMO partnerships, and manufacturing economics for biologics, cell and gene therapies, cultivated meat, and biomaterials.
Hosted by Dr. David Brühlmann, CMC strategist, former Bioprocess Innovation Manager at Merck, PhD in glycoengineering, and close to 20 years of biomanufacturing experience. Smart Biotech Scientist delivers actionable insights for the people doing the hard work of turning promising molecules into scalable, regulatory-ready therapies.
This podcast is for you if:
- You are a process development scientist or CMC lead managing a technology transfer, scale-up, or CDMO partnership
- You are a biologics developer working on upstream or downstream process development, cell culture optimization, or GMP manufacturing readiness
- You are a biotech founder preparing for an IND filing or Series A fundraise, and need a CMC strategy that holds up under investor and regulatory scrutiny
- You are building or advising an early-stage biopharma team and need to make smart manufacturing decisions with limited resources
What you will learn:
CMC strategy and regulatory planning, bioprocess scale-up from lab to clinical and commercial manufacturing, cell culture process development and media optimization, technology transfer best practices, CDMO selection and partnership management, hybrid modeling, manufacturing economics, continuous manufacturing, digitization, and Industry 4.0 in biopharma.
Top 10 life sciences podcast with 200+ episodes and guests from Merck, FUJIFILM Irvine Scientific, Cytiva, KBI Biopharma, Eppendorf, and biotech innovators worldwide.
New episodes released weekly. Subscribe and join 400+ biotech leaders already using these insights to accelerate development, reduce manufacturing costs, and de-risk scale-up.
Next Steps:
Visit the Website: https://smartbiotechscientist.com
Email us: hello@bruehlmann-consulting.com
Smart Biotech Scientist | The CMC and Bioprocessing Podcast for Process Development and Manufacturing Leaders
269: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung Woo - Part 1
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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