Detector cells used for cell-based viral detection assays are a critical reagent for ensuring viral safety, viral potency, viral
identity, and viral clearance capacity in purification schemes. In many cases this testing is intended to support GMP processes;
therefore, the detector cell banks may need to be prepared and qualified in much the same manner as other critical reagents.
The details of the viral safety evaluation methods are described in Viral Safety Evaluation of Biotechnology Products Derived from
Cell Lines of Human or Animal Origin á1050ñ. Regardless of specific compliance requirements, periodic identification and
qualification of the detector cell banks to be used subsequently for viral infectivity assays is good practice. The following should
be regarded as minimal quality control testing for such detector cell banks: sterility, mycoplasma and viral screening, and cell
identity by DNA fingerprinting, karyology, or isoenzyme analysis. In addition, specific assays for bovine and porcine viruses may
be required if bovine or porcine raw materials were used in preparation of the banks. Bovine Serum á1024ñ and relevant
serum-type specific ancillary materials monographs should be consulted when serum products are used in cell growth media.
