Considering Cell Therapy Product "Good Manufacturing Practice" Status.
作者信息
Bedford Patrick, Jy Juliana, Collins Lucas, Keizer Steven
机构信息
Centre for Commercialization of Regenerative Medicine (CCRM), Toronto, ON, Canada.
出版信息
Front Med (Lausanne). 2018 Apr 30;5:118. doi: 10.3389/fmed.2018.00118. eCollection 2018.
Abstract
摘要
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Considering Cell Therapy Product "Good Manufacturing Practice" Status.
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3
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EMBO Mol Med. 2017 Sep;9(9):1183-1197. doi: 10.15252/emmm.201607485.
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Appl Transl Genom. 2016 Nov 11;11:27-39. doi: 10.1016/j.atg.2016.11.001. eCollection 2016 Dec.
5
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