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Manufacture of Third-Generation Lentivirus for Preclinical Use, with Process Development Considerations for Translation to Good Manufacturing Practice

Lookup NU author(s): Dr Carolina Gandara de Souza, Val Affleck, Dr Elizabeth Stoll

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This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).

Abstract

© Carolina Gándara et al. 2018. Lentiviral vectors are used in laboratories around the world for in vivo and ex vivo delivery of gene therapies, and increasingly clinical investigation as well as preclinical applications. The third-generation lentiviral vector system has many advantages, including high packaging capacity, stable gene expression in both dividing and post-mitotic cells, and low immunogenicity in the recipient organism. Yet, the manufacture of these vectors is challenging, especially at high titers required for direct use in vivo, and further challenges are presented by the process of translating preclinical gene therapies toward manufacture of products for clinical investigation. The goals of this paper are to report the protocol for manufacturing high-titer third-generation lentivirus for preclinical testing and to provide detailed information on considerations for translating preclinical viral vector manufacture toward scaled-up platforms and processes in order to make gene therapies under Good Manufacturing Practice that are suitable for clinical trials.

Publication metadata

Author(s): Gandara C, Affleck V, Stoll EA

Publication type: Article

Publication status: Published

Journal: Human Gene Therapy Methods

Year: 2018

Volume: 29

Issue: 1

Pages: 1-15

Print publication date: 01/02/2018

Online publication date: 24/01/2018

Acceptance date: 17/11/2017

Date deposited: 20/02/2018

ISSN (print): 1946-6536

ISSN (electronic): 1946-6544

Publisher: Mary Ann Liebert Inc.

URL: https://doi.org/10.1089/hgtb.2017.098

DOI: 10.1089/hgtb.2017.098

PubMed id: PMC5806069

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