Scalable Lentiviral Vector Production Service

Lentiviral vectors (LVs) have important applications in the field of gene and cell therapy. However, producing sufficient quantities of LVs for clinical applications remains challenging, prompting the field to develop suspension processes that facilitate large-scale production. Creative Biogene offers strategies for LV production using stable HEK293SF cell lines to help customers achieve mass production and commercial manufacturing of lentiviral vectors.

Overview

Large-scale production of lentiviral vectors (LV) continues to face a number of obstacles, including the production of sufficient vectors to meet the needs of treated patients and the production of high quality and batch consistent vectors for clinical applications. The use of stable production cell lines for LV production is gradually receiving increasing attention. This approach provides a reliable strategy that combines the need for scalability, reproducibility, and robustness to help the LV field move toward large-scale production.

Fig. 1 Overview of large-scale vector manufacturing. ( Milone, et al.; 2018)

Benefits of Using Producer Cell Lines for LV Production

Traditionally, LVs are generated by transient transfection using 3 to 4 plasmids. However, this approach is laboratory intensive, dependent on plasmid availability and not easily scalable directly. To further facilitate the scalability of the LV production process, Creative Biogene employs a suspension-grown HEK293 cell line, which provides immediate scalability and is in the 10⁶ transduction units (TU)/mL range without optimization. This production strategy not only avoids contamination caused by excess plasmid and reagent residues in transient transfections, but also enables rapid virus scale-up culture through highly enhanced suspension cultures and disposable fixed-bed bioreactors.

Strategy for High-Yield LV Production at Creative Biogene

Creative Biogene achieves high quality production of LV through a perfusion culture-based strategy. We can select the most appropriate production method and optimize the process parameters according to the needs of our customers. Increase cell density and LV recovery before and after induction by using basic commercial media and perfusion mode, or utilize enhanced media formulations to achieve target cell density for induction in batch mode followed by perfusion mode after induction, thereby increasing titers and facilitating large-scale LV production and commercial manufacturing.

LV Production Process

The production of lentivirus by stable cell lines requires expertise in cell culture, molecular biology, purification and quality control, and is a complex multi-step process that requires careful planning and execution. Creative Biogene's experienced scientists can provide customers with a comprehensive solution in the upstream and downstream processes of lentivirus production.

LV Production Process

Our Capabilities

Stable production cell lines
Shake flask scale or bioreactor scale LV production.
Gene transfer analysis for functional LV quantification
Droplet digital PCR analysis for total LV quantification

Creative Biogene is a trusted partner with an experienced production team and a variety of advanced technologies to provide cost-effective LV production services to our customers. Commercialization and mass production of LV is facilitated by providing stable cell lines to facilitate the shift to a more scalable, reproducible and robust approach. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.

Reference:

Milone, M.C.; et al. Clinical use of lentiviral vectors. Leukemia. 2018;32(7):1529-1541.

* For research use only. Not intended for any clinical use.

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