Adventitious agents are a major concern when using mammalian cell lines for production of a biotechnology product or biological. BioReliance performs the classic in vitro assay designed to detect adventitious viruses in cell banks, virus seed stock, raw materials and final products, including:
- Adventitious virus assay
- Porcine and bovine adventitious virus assay as described in the 9 CFR
- A range of assays addressing specific contamination risks also is available
The BioReliance CRO team is available to help you design and execute the testing services needed to ensure your biologicals are free of viral contamination. BioReliance experts also are available for consultation on development and validation services for emerging viruses.
To see our in vitro testing services for adventitious agents, use the search tool to the right or click here.
Details about our in vitro adventitious virus assays
The goal is to create the best possible chance of catching contamination in your production cells. Each in vitro assay is fully validated in accordance with ICH Q2 (R1) guidelines and EP 2.6.21.
In vitro assays can be configured for testing serum, cell lysates, enzymes, raw materials, and other non-serum samples for the presence of adventitious agents by inoculating indicator cell lines with the above samples. Cultures are then maintained for 21 days and monitored for cytopathic effects (CPE).
Cultures exhibiting CPE immediately are harvested, fixed and screened for viruses. After 21 days, all remaining cultures are harvested examined for the presence of specific viruses by fluorescent antibody staining techniques. Further, the cultures are assayed for hemadsorption (hemagglutinin on the surface of viruses adsorbs to red blood cells (RBCs), resulting in the clumping of RBCs) to detect viruses that are difficult to see by fluorescence.
Does BioReliance offer other virology testing assays for adventitious agents?
BioReliance offers a wide range of services to enable production of biologicals free of contamination including:
The BioReliance CRO team has a broad experience in testing and detecting adventitious agents using a wide range of methods. The BioReliance research staff is available to support your virology testing needs from design through execution.