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A strategic road map to filing a Biologics License Application for a pluripotent stem cell derived therapeutic product.

作者信息

Creasey Abla A, Stacey Glyn, Bharti Kapil, Sato Yoji, Lubiniecki Anthony

机构信息

California Institute for Regenerative Medicine (CIRM), Oakland, CA, USA.

International Alliance for Biological Standardization (IABS), Geneva, Switzerland.

出版信息

Biologicals. 2019 May;59:68-71. doi: 10.1016/j.biologicals.2019.03.007. Epub 2019 Apr 30.

DOI:10.1016/j.biologicals.2019.03.007
PMID:31053443
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7476766/
Abstract
摘要

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本文引用的文献

1
Report of the international conference on manufacturing and testing of pluripotent stem cells.多能干细胞制造与测试国际会议报告
Biologicals. 2018 Nov;56:67-83. doi: 10.1016/j.biologicals.2018.08.004. Epub 2018 Aug 24.