SKyvec™ Lenti For In Vivo Applications

Once lentiviral vector is administered directly to patients, it stops being an intermediate and becomes the final drug product, and regulators expect tighter impurity control and fuller potency data.

Traditional resin-based ion exchange often recovers only ~15-30% of viral particles, a real limit on higher-dose systemic delivery. Here, a membrane-based capture step drops the low-salt wash and uses convective flow, lifting total recovery from ~20% to ≥70%, with functional titer recoveries above 85% and ~98% HCP clearance. Downstream processing runs 1 to 2 days from harvest to drug substance, and the platform scales to 500 L. The data also cover analytical testing and regulatory expectations for in vivo programs.

See the recovery and clearance numbers.