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
270: How to Turn Mesenchymal Stem Cells into Programmable Cancer Delivery Vehicles with Jun Yung Woo - Part 2
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In the biotech industry, advancing cell-based therapies is not just about innovation. It's about solving real gaps where conventional treatments fall short, especially against complex, aggressive tumors.
In this episode of the Smart Biotech Scientist Podcast, host David Brühlmann welcomes Jun Yung Woo, Co-Founder of AGEM Bio, who offers an in-depth look at the science and strategy behind engineered mesenchymal stem cells (MSCs), with a focus on why glioblastoma is the right proving ground for the platform.
Topics discussed:
- Why glioblastoma is the right Phase I indication: infiltrative growth, immunosuppression, and STING pathway deficiencies that make GBM uniquely suited to the platform (02:43)
- The surgical workflow: intracavity MSC delivery during tumor resection, oral 5-FC administration, and how engineered cells act as local bioreactors in the resection cavity (04:05)
- Mechanisms by which engineered MSCs target heterogeneous and invasive tumors through shared vulnerabilities rather than antigen recognition (05:58)
- Overcoming immune rejection with allogeneic therapies and the unique immunological profile of MSCs (07:32)
- Manufacturing and scale-up: addressing donor variability, GMP production, and building a reproducible process (09:16)
- Why GMP manufacturing should be designed in from the earliest stages of research (10:50)
- Beyond glioblastoma: expanding the platform to other solid tumors, regenerative medicine, and chronic inflammatory disease (11:27)
- Strategies for international trial expansion and partnerships beyond Singapore (12:41)
- Reframing MSCs from stem cell therapy to programmable delivery platform: the MSC 2.0 thesis (14:10)
Smart insight: The shift Jun Yung articulates is from treating stem cells as the therapy to treating them as programmable therapeutic vehicles. Once you can reliably engineer, manufacture, and preserve their function, the limitation is no longer what the cell naturally does. It becomes what biology you can encode into it. Glioblastoma is the proving ground, and the platform's reach extends to liver cancers, sarcomas, peritoneal malignancies, and chronic inflammatory disease.
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