The transition of lentiviral vectors (LVVs) from an ex vivo manufacturing tool to a directly administered therapeutic product introduces new requirements for product purity, potency, safety, target specificity and stability. This presentation explores a feasibility-first approach to developing fit-for-purpose LVV manufacturing processes for in vivo applications. Case studies from customer programs developing LVVs for in vivo applications will be presented to demonstrate how adaptable platform processes, impurity control and comprehensive product characterization can support customer-specific vector designs.
The presentation examines how construct and envelope choices can influence productivity, recovery, purity and potency, and how early process assessment can help identify development risks before GMP scale-up. It also introduces enhanced downstream processing and advanced analytical approaches for characterizing full, partial and empty LVV particles and assessing genomic RNA integrity. By integrating process development, advanced analytics, scalable manufacturing and CMC readiness, developers can establish a stronger pathway for translating complex targeted LVV concepts into clinic-ready products.
