Q-One Biotech develops novel infectivity assay for bovine polyomavirus
Scientists working in Q-One Biotech’s expert virology R&D team at Glagow have come up with a new, unique infectivity assay for the detection of bovine polyomavirus (BPyV). With this diagnostic tool, biological products that have been exposed to bovine derived materials can be screened for the presence of this infectious agent.
Bovine polyomavirus (BPyV) has been at the centre of increasing regulatory concern in recent months. A high proportion of foetal calf serum batches that are known to be contaminated with BPyV prompted the European regulatory authorities to discuss including this specific virus in guidelines for serum testing.
BPyV is a potential zoonotic agent with reports that serum antibody has been detected in people who had occupational exposure to animals. The virus can also infect primate cells, so there is a serious risk of BPyV contamination of cell cultures used for research, diagnostics or production purposes.
Draft European guidelines have been issued, suggesting that a suitable assay for detection of BPyV should be performed on bovine serum used in the manufacture of human biological products. The FDA has also been involved in discussions concerning the potential risks associated with polyomaviruses in vaccine substrates.
Studies using Q-PCR confirmed that a high percentage of serum batches test positive to BPyV. Such molecular amplification assays, however, cannot distinguish between BPyV DNA and infectious virus.
Q-One Biotech’s expert virology R&D team devised a new, unique infectivity assay for detecting BPyV. Biological products that have been exposed to bovine-derived materials can now be screened for the presence of the infectious agent. This technology will provide manufacturers of therapeutics with the reassurance that no infectious agents of this nature are present in their products.
Keywords : Q-One Biotech Scotland Bovine polyomavirus BPyV Foetal calf serum Contamination Infectivity Screening assay Regulatory authorities FDA
