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【BIO】Could the adventitious virus test only be performed in donor testing since the cells number in autologous cell therapy products is limited?

刊登日期:2019-11-11  |  點閱次數 : 410 次 

In early clinical trials, autologous cells are usually with limited cell expansion, in vitro culture, and limited number of cells, it does not necessarily to establish the cell bank system. In this case, addition to perform designated donor screening and donor testing that meet regulatory requirements for the subject, the potential contaminations of adventitious virus during the production of cells should be evaluated. For example, when bovine or porcine-derived ingredients (serum, serum components, trypsin, etc.) have been used in the cell manufacturing process, those ingredients or the produced cells should perform the bovine or porcine species-specific virus testing.

 

(中文版)


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