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Design of a Tumorigenicity Test for Induced Pluripotent Stem Cell (iPSC)-Derived Cell Products.诱导多能干细胞（iPSC）衍生细胞产品致瘤性试验的设计
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An FDA perspective on preclinical development of cell-based regenerative medicine products.美国食品药品监督管理局对基于细胞的再生医学产品临床前开发的观点。
Nat Biotechnol. 2014 Aug;32(8):721-3. doi: 10.1038/nbt.2971.
3
Potency assay development for cellular therapy products: an ISCT review of the requirements and experiences in the industry.细胞治疗产品效价测定方法的开发：ISCT 对行业要求和经验的综述。
Cytotherapy. 2013 Jan;15(1):9-19. doi: 10.1016/j.jcyt.2012.10.008.
4
Safety of cell therapy with mesenchymal stromal cells (SafeCell): a systematic review and meta-analysis of clinical trials.间充质基质细胞（SafeCell）细胞疗法的安全性：临床试验的系统评价和荟萃分析。
PLoS One. 2012;7(10):e47559. doi: 10.1371/journal.pone.0047559. Epub 2012 Oct 25.
5
Alternative strategies for toxicity testing of species-specific biopharmaceuticals.物种特异性生物制药毒性测试的替代策略。
Int J Toxicol. 2009 May-Jun;28(3):230-53. doi: 10.1177/1091581809337262.

Reducing Risks and Delays in the Translation of Cell and Gene Therapy Innovations into Regulated Products.

作者信息

Tsokas Katherine, McFarland Richard, Burke Carl, Lynch Jessica L, Bollenbach Thomas, Callaway D Allen, Siegel Jay

机构信息

Janssen Research and Development, LLC.

Advanced Regenerative Manufacturing Institute.

出版信息

NAM Perspect. 2019 Sep 30;2019. doi: 10.31478/201909d. eCollection 2019.

DOI:10.31478/201909d
PMID:34532664
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8406503/
Abstract
摘要