Scalability of Lentiviral Production with the CTS LV-MAX Lentiviral Production System in Bioreactors

The Gibco™ CTS™ LV-MAX™ Lentiviral Production System provides a scalable and high-yield lentiviral vector (LV) production platform. It is based on a high-density suspension culture of HEK293F–derived Viral Production Cells that have been optimized for viral production in chemically defined LV-MAX Production Medium. Scalable LV production of greater than 1 x 10⁸ TU/mL LV (unconcentrated) can be achieved using our proprietary lipid nanoparticle transfection reagent in combination with an LV-specific enhancer and production supplement. All components work synergistically to help generate superior, functional lentiviral particles compared to conventional polyethylenimine (PEI), serum-based culture system; therefore making CTS LV-MAX a cost-effective solution for LV production. All components of the CTS LV-MAX system are serum-free, xeno-free, manufactured in conformity with current GMP guidelines for medical devices (21 CFR Part 820), and follow USP <1043> and European Pharmacopoeia (Ph. Eur.) 5.2.12 recommendations. CTS LV-MAX products will have a Drug Master File (DMF) in the United States, Canada, and Japan or a Regulatory Support File in other regions available per request to support regulatory filings.

We demonstrate herein that the CTS LV-MAX Lentiviral Production System is readily scalable into a 3 L HyPerforma™ Glass Bioreactor with LV titers comparable to shake flask controls without the need for additional supplements or reagents outside of those provided in the CTS LV-MAX Lentiviral Production System. Optimal system performance was observed across a range of P/Vs, emphasizing the robustness of the CTS LV-MAX system for LV production. These results demonstrate the scalability of the CTS LV-MAX system and its adaptability to large-scale viral vector production processes.