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Back to In Vitro Testing
Many cell culture systems require additives derived from bovine or porcine origin, such as bovine fetal or newborn sera, insulin, transferrin, various growth factors, and trypsin. The Food and Drug Administration (FDA) recommends that reagents such as serum or animal-derived additives that are added to cell culture medium be certified to be free of contaminants and adventitious agents. This guideline also requires that the source of an animal-derived additive as well as documentation of testing for adventitious agents be known about such additives.
BioReliance offers in vitro assays to detect the presence of bovine or porcine viruses for both raw materials/additives and cell lysates. Testing of cell lysates derived from master cell banks (MCBs) and cells at the limit of in vitro cell age is strongly recommended, even if the particular MCB was produced without the use of bovine- or porcine- derived additives. Even though a cell bank can be adapted to grow without those additives, the parental cell line could have been exposed to bovine- or porcine- derived reagents or both at some point in its history.
In addition to in vitro viral assays for specific bovine and porcine viruses, BioReliance also offers an in vitro assay and a quantitative polymerase chain reaction (QPCR) for detection of human cytomegalovirus (CMV). CMV is a distinct, widely distributed subgroup of herpesviruses that induce nuclear and cytoplasmic inclusions. Similar to other herpesviruses, CMV can establish persistent and latent infections and they are associated with oncogenic disease and other immunosuppressive or degenerative conditions. Immunocompromised people are predisposed to a primary CMV infection or to awakening of a latent infection, which can lead to a fulminant, life-threatening disease that can be difficult to treat despite available antiviral drugs.
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