GMP CAR-T cell production

Adrian P Gee

doi:10.1016/j.beha.2018.01.002

GMP CAR-T cell production

Best Pract Res Clin Haematol. 2018 Jun;31(2):126-134. doi: 10.1016/j.beha.2018.01.002. Epub 2018 Feb 2.

Author

Adrian P Gee¹

Affiliation

¹ cGMP Facilities, Center for Cell & Gene Therapy, Baylor College of Medicine, Houston, TX 77030, USA. Electronic address: agee@bcm.edu.

PMID: 29909913
DOI: 10.1016/j.beha.2018.01.002

Abstract

The clinical success achieved using CD19-directed CAR-T cells has stimulated many academic institutions to explore the feasibility of manufacturing these, and other CAR-T cells, in-house. This article reviews the issues that must be addressed in order to achieve this goal. It includes the manufacturing infrastructure, the regulatory environment, practical aspects of production, and the costs involved.

Keywords: CAR-T cells; Good manufacturing practices; Manufacturing.

Publication types

Research Support, Non-U.S. Gov't
Review

MeSH terms

Antigens, CD19 / biosynthesis
Antigens, CD19 / immunology*
Humans
Immunotherapy, Adoptive*
Receptors, Chimeric Antigen / immunology*
Receptors, Chimeric Antigen / metabolism
T-Lymphocytes / immunology*
T-Lymphocytes / metabolism

Substances

Antigens, CD19
CD19 molecule, human
Receptors, Chimeric Antigen