ISCT survey on hospital practices to support externally manufactured investigational cell-gene therapy products

Authors

Alexey Bersenev, Immuno-Gene Therapy Committee, International Society for Cell and Gene Therapy, Vancouver, BC, Canada; Department of Laboratory Medicine, Yale School of Medicine, Yale University, New Haven, CT. Electronic address: alexey.bersenev@yale.edu.
Michael P. Gustafson, Immuno-Gene Therapy Committee, International Society for Cell and Gene Therapy, Vancouver, BC, Canada; Department of Laboratory Medicine and Pathology, Mayo Clinic in Arizona, Phoenix, AZ.
Patrick J. Hanley, Immuno-Gene Therapy Committee, International Society for Cell and Gene Therapy, Vancouver, BC, Canada; Center for Cancer and Immunology Research, Children's National Hospital, and the George Washington University, Washington, DC.

Document Type

Journal Article

Publication Date

1-1-2022

Journal

Cytotherapy

Volume

24

Issue

1

DOI

10.1016/j.jcyt.2021.09.009

Keywords

CAR T; cellular therapy; gene therapy; immunotherapy

Abstract

There is considerable interest in the next generation of personalized medicine, especially cell and gene therapy products such as chimeric antigen receptor T cells (CAR-Ts). Unlike other small molecules or pharmacologic drugs, most existing cell or cell-based gene therapy products (CGTs) require apheresis collection of the patient or donor, subsequent manufacture of the product, and final shipment of the product to the clinical site for infusion. Whereas traditional pharmaceutical drugs have involved the drug sponsor and the clinical site and clinical pharmacy, this new manufacturing paradigm has evolved, in many cases, to include an apheresis center, a cell processing lab, the sponsor's manufacturing facility, and a clinical site with or without a pharmacy. Here we report the results of a survey of current practices handling investigational CGTs conducted by the Immuno-Gene Therapy committee of the International Society of Cell and Gene Therapy.

APA Citation

Bersenev, Alexey; Gustafson, Michael P.; and Hanley, Patrick J., "ISCT survey on hospital practices to support externally manufactured investigational cell-gene therapy products" (2022). GW Authored Works. Paper 435.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/435

Department

Pediatrics