Process developent of a serum-free and scalable lentiviral vector manufacturing platform for cellular immunotherapies
February 6 – 10, 2022
Lentiviral vectors (LV) have played a critical role in gene delivery for ex vivo gene-modified cell therapies, including T cells and NK cells; however, a large-scale manufacturing process is needed to cope with the increasing demand from the cell and gene therapy sector. Single-use fixed-bed bioreactors, such as the iCELLis bioreactor, provide a promising automated, scalable platform for the generation of large volumes of GMP-grade LV. Fixed-bed bioreactors have already been shown to generate high LV titers; nevertheless, most of the work currently undertaken in the field relies on serum-containing medium formulations. This is largely because to date serum-containing media produces higher viral titer yields and an increased LV stability during the down-stream processing of the product. However, relying on serum-based processes adds significant supply chain and manufacturing risk to the process.
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Carme Ripoll Fiol, Dale Stibbs, Qasim Rafiq, and John Welsh, "Process developent of a serum-free and scalable lentiviral vector manufacturing platform for cellular immunotherapies" in "Advancing Manufacture of Cell and Gene Therapies VII", Sharon Brownlow, Cell & Gene Therapy Catapult, UK; Sean Palecek, University of Wisconsin, USA; Damian Marshall, Achilles Therapeutics, UK; Fernanda Masri, Cell & Gene Therapy Catapult, UK Eds, ECI Symposium Series, (2022). https://dc.engconfintl.org/cellgenetherapies_vii/34