Enhancing LVV Manufacturing: Eliminating Barriers To In Vivo And Ex Vivo CAR-T Delivery

As CAR‑T therapy moves beyond traditional ex vivo engineering toward in vivo gene delivery, lentiviral vector (LVV) production faces stricter demands on yield, impurity clearance, scalability, and compliance. The session explains how design and quality expectations diverge between in vivo and ex vivo use—highlighting higher dose requirements, broader analytical characterization, and tighter plasmid specifications for direct patient administration. It outlines scalable, cost‑efficient strategies for industrializing LVV manufacturing, including robust downstream purification tuned to maintain vector integrity and support consistent, reproducible outcomes. Attendees gain perspective on how evolving regulatory frameworks are shaping platform development and CMC controls, with emphasis on process robustness, batch consistency, and readiness for systemic administration. The discussion situates LVVs within the broader trend toward in vivo CAR‑T, summarizing practical approaches to meet emerging clinical and regulatory expectations while improving manufacturability and cost efficiency.