Cell and gene therapy manufacturing capabilities in Australia and New Zealand

Cell and gene therapy manufacturing capabilities in Australia and New Zealand.

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Item Type: Article
Status: Published
Official URL: https://doi.org/10.1016/j.jcyt.2019.10.010
Journal or Publication Title: Cytotherapy
Volume: 21
Number: 12
Page Range: pp. 1258-1273
Date: 2019
Divisions: Gene and Stem Cell Therapy
Depositing User: General Admin
Identification Number: 10.1016/j.jcyt.2019.10.010
ISSN: 14653249
Date Deposited: 17 Dec 2020 04:00
Abstract:

Cell and gene therapy products are rapidly being integrated into mainstream medicine. Developing global capability will facilitate broad access to these novel therapeutics. An initial step toward achieving this goal is to understand cell and gene therapy manufacturing capability in each region. We conducted an academic survey in 2018 to assess cell and gene therapy manufacturing capacity in Australia and New Zealand. We examined the following: the number and types of cell therapy manufacturing facilities; the number of projects, parallel processes and clinical trials; the types of products; and the manufacturing and quality staffing levels. It was found that Australia and New Zealand provide diverse facilities for cell therapy manufacturing, infrastructure and capability. Further investment and development will enable both countries to make important decisions to meet the growing need for cell and gene therapy and regenerative medicine in the region.

Keywords: Good Manufacturing Practice; cell therapy; gene therapy; manufacturing; regenerative medicine.

Copyright © 2019 International Society for Cell and Gene Therapy. Published by Elsevier Inc. All rights reserved.

Creators:
Creators
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O'SULLIVAN, GABRIELLE M.
UNSPECIFIED
VELICKOVIC, ZLATIBOR M.
UNSPECIFIED
KEIR, MICHELLE W.
UNSPECIFIED
MACPHERSON, JANET L.
UNSPECIFIED
RASKO, JOHN E.J.
UNSPECIFIED
Last Modified: 17 Dec 2020 04:00
URI: https://eprints.centenary.org.au/id/eprint/131

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