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Cell and gene therapy manufacturing capabilities in Australia and New Zealand
Cytotherapy ( IF 4.5 ) Pub Date : 2019-12-01 , DOI: 10.1016/j.jcyt.2019.10.010
Gabrielle M O'Sullivan 1 , Zlatibor M Velickovic 2 , Michelle W Keir 3 , Janet L Macpherson 2 , John E J Rasko 4
Affiliation  

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.

中文翻译:

澳大利亚和新西兰的细胞和基因疗法制造能力

细胞和基因治疗产品正在迅速融入主流医学。发展全球能力将有助于广泛获得这些新型疗法。实现这一目标的第一步是了解每个地区的细胞和基因治疗制造能力。我们在 2018 年进行了一项学术调查,以评估澳大利亚和新西兰的细胞和基因疗法制造能力。我们检查了以下内容:细胞疗法生产设施的数量和类型;项目、并行过程和临床试验的数量;产品类型;以及制造和质量人员配备水平。研究发现,澳大利亚和新西兰为细胞治疗制造、基础设施和能力提供了多样化的设施。
更新日期:2019-12-01
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