Testing for adventitious agents after the preparation of MCBs and WCBs should be routine, and USP general chapters Viral
Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin á1050ñ and Virology Test Methods á1237ñ provide additional testing guidance (see also the FDA 2010 guidance cited in the Appendix). Testing for mycobacterial contamination, which may not be isolated in standard sterility testing, also can be considered for some cell substrates.
Representative vials should be retrieved and tested for contamination (bacteria, fungi, Mycoplasma, and viruses). Numerous
well-established methods are available for detecting Mycoplasma in cell cultures (see USP general chapter Mycoplasma Tests á63ñ).
