Scalability of lentiviral production with the CTS LV-MAX lentiviral production system in bioreactors

The Gibco™ CTS™ LV-MAX™ Lentivirus Production System provides a scalable, high throughput lentiviral (LV) vector production platform. It is based on high-density suspension culture of HEK293F-derived virus-producing cells that have been optimized for virus production in chemically defined LV-MAX production medium. Scalable LV production 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 activator and production supplement. All components work synergistically to help generate superior and functional lentiviral particles compared to conventional polyethyleneimine (PEI) serum-based culture system; thus making CTS LV-MAX a cost effective solution for LV generation. All components of the CTS LV-MAX System are serum-free, xeno-free, manufactured under current GMP guidelines for medical devices (21 CFR Part 820), and comply with USP 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 upon request to support regulatory filings.

Here we demonstrate that the CTS LV-MAX lentiviral production system is easily scaled up in a 3 L HyPerforma™ glass bioreactor with LV titers comparable to shake flask controls without the need for supplements or additional reagents beyond those supplied. in the CTS LV-MAX Lentiviral Production System. Optimal system performance was observed over a range of P/V, underscoring 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.