By Aziza Manceur, Anja Rodenbrock, Danielle Jacob, Mehul Patel, Sushma G. Puttaswamaiah, July Dorion-Thibaudeau, Julia Transfiguracion, Krishnaraj Tiwari, and Martin Loignon
Volume 24, Open Access (November 2025)
Lentiviral vectors (LVV) are widely used in an increasing number of approved cell and gene therapies, and benchmarking is important in evaluating production processes and products. We have produced a lentiviral vector reference material (LVV-RM) that expresses the common marker gene (green fluorescent protein [GFP]) to enable data comparisons and support LVV research programs. To generate that reference material, we have applied our previously developed fed-batch process to a 100 L production using an inducible LVV-producer cell line. The LVV material was harvested three days post-induction from a 200 L single-use bioreactor. A downstream purification process was also developed and scaled-up to meet production requirements: It consisted of nuclease digestion, clarification by depth filtration, chromatography capture using CIM-QA monolith anion exchangers, and ultrafiltration/diafiltration using a hollow fiber membrane prior to bulk-filling the final product. A total of 4.4 L of diafiltered and concentrated LVV product was obtained (9.2×1010 particles/mL, 3.6×107 TU/mL) and stored at -80°C. Nearly 8000 vials are now available to the LVV community via the American Type Culture Collection (ATCC)…
Citation: Manceur, A.; Rodenbrock, A.; Jacob, D.; Patel, M.; Puttaswamaiah, S. G.; Dorion-Thibaudeau, J.; Transfiguracion, J.; Tiwari, K.; Loignon, M. Large-scale production and purification of a lentiviral vector reference material. BioProcessing Journal 2025, 24. DOI: 10.12665/J24OA.Manceur
Posted online November 11, 2025