Lessons Learned On Commercializing Lentiviral Vector As A Drug Substance: A Joint Roundtable With Adaptimmune And Miltenyi Bioindustry

In August 2024, Adaptimmune was granted accelerated FDA approval for TECELRA® (afami-cel), a metastatic or unresectable synovial sarcoma treatment. TECELRA® is groundbreaking as it represents the first approved engineered T cell therapy for solid tumors as well as the first T cell receptor-engineered T cell (TCR-T) product to receive approval.

The commercialization of a cell therapy, particularly one involving lentiviral vector as a drug substance, is immensely complex. Adaptimmune collaborated with Miltenyi Bioindustry, the CDMO services arm of Miltenyi Biotec, for the development and production of lentiviral vectors for TECELRA®. Watch to hear from experts from both Miltenyi Bioindustry and Adaptimmune as they delve into this process during a roundtable discussion. Explore how your focus and strategy need to evolve as you advance beyond clinical manufacturing, methods for process characterization and validation, and key quality factors to consider when preparing your process and facility for commercial-scale production.