Cell and gene therapy manufacturing capabilities in Australia and New Zealand |
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| Authors: | GABRIELLE M. O&#x SULLIVAN,ZLATIBOR M. VELICKOVIC,MICHELLE W. KEIR,JANET L. MACPHERSON,JOHN E.J. RASKO |
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| Affiliation: | 1. Research Ethics & Governance Office, Royal Prince Alfred Hospital (RPAH), Sydney Local Health District (SLHD), Sydney, Australia;2. Department of Cell and Molecular Therapies, RPAH, SLHD, Sydney, Australia;3. School of Medicine, The University of Sydney, Sydney, Australia;4. Gene and Stem Cell Therapy Program, Centenary Institute, The University of Sydney, Sydney, Australia |
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| 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. |
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| Keywords: | cell therapy gene therapy Good Manufacturing Practice manufacturing regenerative medicine |
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