Episode Details

When every batch belongs to a single patient, a single centralized facility cannot serve the world. In Part 2, Chantale Bernatchez moves from process development into the broader consequences of that reality: the manufacturing model built around clinical proximity, the global alliance bringing TIL production to regions with no current access, and the next-generation engineered approaches redefining what these therapies can do.

Chantale Bernatchez is Head of Process Development at CTMC, a joint venture between Resilience and MD Anderson Cancer Center. If you missed Part 1, she explained how specific activation changes recovered a failing TIL process from 50% to 95% success in heavily pre-treated patients.

Topics discussed:

• How close collaboration with MD Anderson accelerates clinical development and regulatory readiness (03:08)
• CTMC’s approach to process development and adapting to innovative technologies (05:15)
• The value of partnership-based models versus traditional CDMO-driven approaches (06:24)
• Global technology transfer: building alliances to expand access to cell therapies, with a case study in Brazil (07:35)
• Key barriers and solutions for cell therapy manufacturing in new regions (09:41)
• Practical advice for scientists starting in GMP manufacturing and process development (10:46)
• Future directions in CAR T and TIL, including logic-gated CARs, engineered TILs, and in vivo therapies (12:24)
• The importance of continued innovation and collaboration to expand global patient access (17:39)

Smart insight:

The choice of manufacturing partner in cell therapy is not a logistics decision. It is a process development decision. CTMC's collaboration-based model exists because many early-stage developers arrive without a process robust enough to hand over. For scientists in small or mid-sized companies, engaging that kind of partnership too late, or on purely transactional terms, is one of the most avoidable risks in early clinical development.

If you’re interested in exploring further the concepts we touched on, such as cell therapy manufacturing, process control, and scaling living therapies—take a look at these related discussions:

• Episodes 125 - 126: How to Enhance Cell Engineering Using Mechanical Intracellular Delivery with Armon Sharei
• Episodes 109 - 110: Spinning Like Earth: Designing Low-Shear Bioreactors for Better Cell Culture with Olivier Detournay
• Episodes 105 - 106: From Proteins to Cell Therapy: Why ATMPs Aren’t Just Complex Biologics with Oliver Kraemer

Connect with Chantale Bernatchez:

LinkedIn: www.linkedin.com/in/chantale-bernatchez-22b09511

CTMC website: www.ctmc.com

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