临床试验
胎牛血清
质量(理念)
医学
医学物理学
计算机科学
内科学
化学
细胞
哲学
生物化学
认识论
作者
Ohad Karnieli,Oryan Makler Friedner,Julie Allickson,Nan Zhang,Sunghoon Jung,D. Fiorentini,Eytan Abraham,Shannon Eaker,Tan Yong,Allan Chan,Sarah Griffiths,Amy K. Wehn,Steve Oh,Ohad Karnieli
出处
期刊:Cytotherapy
[Elsevier BV]
日期:2017-12-06
卷期号:20 (2): 271-271
被引量:2
标识
DOI:10.1016/j.jcyt.2017.11.007
摘要
The authors apologize for reproducing several sentences from "Human platelet lysate: Replacing fetal bovine serum as a gold standard for human cell propagation?", by Thierry Burnouf, Dirk Strunk, Mickey B.C. Koh, and Katharina Schallmoser, Biomaterials, 76, 371–387, and for failing to cite the article. Additionally, we apologize for reproducing three sentences from "Human AB serum as an alternative to fetal bovine serum for endothelial and cancer cell culture", by D. Canovas and N. Bird, ALTEX 2012;29(4):426-8, and for not citing this work. Our paper was a joint effort of an expert committee with multiple authors of which each one wrote several parts in several sections trying to reach a consensus among the experts. Therefore, within the multiple revisions the relevant citations were mishandled. Once again, we apologize to the above authors for these failures and to the readers, and thank you for your understanding. A consensus introduction to serum replacements and serum-free media for cellular therapiesCytotherapyVol. 19Issue 2PreviewThe cell therapy industry is a fast-growing industry targeted toward a myriad of clinical indications. As the cell therapy industry matures and clinical trials hit their pivotal Phase 3 studies, there will be a significant need for scale-up, process validation, and critical raw material quality assurance. Part of the well discussed challenges of upscaling manufacturing processes there is a less discussed issue relating to the availability of raw materials in the needed quality and quantities. The FDA recently noted that over 80% of the 66 investigational new drug (IND) applications for mesenchymal stem cell (MSC) products analyzed described the use of FBS during manufacturing. Full-Text PDF
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