A major concern when using mammalian cell lines for production of a therapeutic is the risk of contamination by endogenous and adventitious viruses. For this reason, Federal regulation 9 CFR requires testing for adventitious agents.
The BioReliance CRO research team provides 9 CFR testing services including:
In short, 9 CFR testing ensures your product quality and optimizes the manufacturing and production process development of therapeutics including biologicals.
The BioReliance research staff has a broad experience in virology testing and is available to provide guidance in protocol design for the most appropriate collection, preparation and evaluation of biologic samples to ensure sample integrity.
Presence of Adventitious Agents in Biological Sample Preparation
BioReliance 9 CFR assays are available to ensure the absence of bovine and porcine adventitious viruses in your therapeutics. Many mammalian cell cultures require fetal bovine serum for optimum growth raising the possibility of contamination with endogenous bovine viruses.
In addition, mammalian cells are typically passaged with the use of porcine trypsin, an enzyme that releases cells from tissue culture plates raising the possibility of contamination with endogenous porcine viruses.
Depending on your production methodology our 9 CFR assays can be configured for testing...
...for the presence of adventitious agents. Contact us about your sample preparation methods to learn how we can help.
How does BioReliance perform 9 CFR assays?
Assays are performed according to 9 CFR regulations, which requires cultures to be maintained for 21 days. Indicator cell lines are used to amplify bovine and porcine viruses and cultures are monitored for cytopathic effects (CPE).
To begin, any culture exhibiting CPE is harvested and fixed. After 21 days, all remaining cultures are harvested and fixed onto slides. The fixed cells are examined for the presence of specific viruses by fluorescent antibody staining techniques.
In addition, the cultures are assayed for hemadsorption (hemagglutinin on the surface of viruses adsorbs to red blood cells (RBCs), resulting in the clumping of RBCs).
Bovine and porcine viruses screened include but are not limited to:
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:
Contact Us for information more information on these assays.
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