Marcus-Sekura C J
Center for Biologics Evaluation and Research, FDA, Bethesda, MD.
Dev Biol Stand. 1992;76:137-40.
A brief overview of retroviral contamination as it relates to biological products produced in cell substrates is presented, including currently used methods of detection and potential risks. The presence of infectious retrovirus in a cell substrate represents what may be a potential risk to recipients of the final product prepared from such cell banks, and it is the approach that can be taken to minimize this risk that is addressed.
本文简要概述了与细胞基质中生产的生物制品相关的逆转录病毒污染情况,包括当前使用的检测方法和潜在风险。细胞基质中传染性逆转录病毒的存在可能对从此类细胞库制备的最终产品的接受者构成潜在风险,本文讨论的是可采取何种方法将这种风险降至最低。