Introduction to the issues: detection of retroviruses and associated risks.
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.
Marcus-Sekura
C J
CJ
Center for Biologics Evaluation and Research, FDA, Bethesda, MD.
D000818:Animals; D001688:Biological Products / Q000009:adverse effects* / Q000302:isolation & purification / Q000592:standards; D002460:Cell Line; D006801:Humans; D006825:Hybridomas / Q000382:microbiology; D012190:Retroviridae / Q000235:genetics / Q000302:isolation & purification*; D012307:Risk Factors; D012449:Safety
D001688:Biological Products