A consensus introduction to serum replacements and serum-free media for cellular therapies
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- 作者：Ohad Karnieli1 ; Ohad@karnieli.com ; Oryan Makler Friedner2 ; Julie G. Allickson3 ; Nan Zhang4 ; Sunghoon Jung5 ; David Fiorentini6 ; Eytan Abraham5 ; Shannon S. Eaker7 ; Tan Kah Yong8 ; Allan Chan8 ; Sarah Griffiths9 ; Amy k. When10 ; Steve Oh8 ; Ohad Karnieli1
- 关键词：serum replacement ; serum free ; defined media ; cell therapy ; animal component free ; platelet lysate ; cGMP media ; fetal bovine serum ; human serum ; xeno free
- 刊名：Cytotherapy
- 出版年：2017
- 出版时间：February 2017
- 年：2017
- 卷：19
- 期：2
- 页码：155-169
- 全文大小：562 K
- 卷排序：19
文摘
The 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. Accumulated data from the past years show an acceleration in serum consumption by at least 10%-15% annually, which suggests that the global demand for serum may soon exceed the supply. Ongoing concerns of safety issues due to risks of various pathogen contaminations, as well as issues related to the aforementioned serum variability that can affect final product reproducibility, are strong motivators to search for serum substitutes or serum-free media. it is important to note that there are no accepted definitions for most of these terms which leads to misleading's and misunderstandings, where the same term might be defined differently by different vendors, manufacturer, and users. It is the drug developer's responsibility to clarify what the supplied labels mean and to identify the correct questions and audits to ensure quality. The paper reviews the available serum replacements, main components, basic strategies for replacement of serum and suggests definitions.