Scalability of 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 USA, Canada and Japan, or a Regulatory Support File in other regions available per request to support regulatory filings.

In this application note, explore the scalability of the Gibco CTS LV-MAX Lentiviral Production System, which can be readily scalable into a 3 L Thermo Scientific™ HyPerforma™ Glass Bioreactor. This system has been used to manufacture lentiviruses without the need for additional supplements and demonstrated comparable growth kinetics to the shake flask controls (2.22 x 108 TU/ml in the stirred-tank bioreactor and 1.90 x 108TU/ml in the 125 ml shake flask). Altogether, these results demonstrate the scalability of the CTS LV-MAX system and how it can be adapted for large-scale viral vector production processes.

This content was supplied by Thermo Fisher Scientific.