In vitro assays
Provided by our partner Vitrology
Cell culture based assays are routinely used to screen for the presence of infectious virus contaminants. Standard in vitro adventitious virus assays, and retrovirus assays, designed to meet US and European guidelines, will be validated and released early in 2008. The initial assays are intended for the characterisation of cell banks, or products derived from cell lines, of human or rodent origin. Assays designed to allow the detection of viruses derived from animal products (e.g. of bovine or porcine origin) are being validated, as are assays for screening virus vectors / vaccines for the presence of infectious contaminants.
Custom projects, and/or the design of customised assays, to meet your specific testing requirements at any stage at available.
- In vitro adventitious agent assays
Regulatory compliant in vitro adventitious agent detection assays involve inoculating a test sample onto various indicator cell lines, capable of detecting a wide range of human and relevant animal viruses.
14 day in vitro assays using a combination of cell lines MRC-5, Vero, CHO-K1, 293, NS0
28 day in vitro assays using a combination of cell lines MRC-5, Vero, CHO-K1, 293, NS0
- Retrovirus infectivity assays
The majority of cells contain endogenous retrovirus or retrovirus-like sequences, and some cells (e.g. murine cells) may produce infectious retrovirus. Regulatory guidelines generally require retrovirus testing by infectivity assay and electron microscopy on master cell banks and cells cultured up to or beyond the limit of in vitro cell age, as well as unprocessed bulk (ICH Q5A, FDA PTC 1993, 1997).
Infectivity assays performed will depend on the anticipated retrovirus contaminant, but may involve, for example, the use of XC assays to detect infectious ecotropic MLV, S+L- assays using feline or mink cell lines, to detect amphotropic or xenotropic MLV, or Mus dunni cells, with either immunofluorescence end-point or a PG4 cell end-point, for detection of ecotropic, amphotropic, xenotropic and mink cell focus-forming viruses.