Detection of adventitious viruses in biologicals--a rare occurrence.

摘要: Adventitious virus assays are performed as part of raw materials testing, cell-line characterization, and lot-release testing biologicals such monoclonal antibodies, gene therapy vectors, recombinant proteins, vaccines. The methods follow guidance provided in the 9 CFR (bovine porcine certain vaccine products) or Points to Consider documents (cell line characterization evaluation majority biologicals). methodologies used types adventitious viruses detected during various samples discussed this paper. detection is quite rare, especially cell banks produced human, mouse, insect substrates. most common scenarios include bovine viral diarrhoea foetal serum samples, parvovirus substrates, murine minute virus, REO Cache Valley Chinese hamster cell-derived bulk harvests. two last-named entities believed be introduced via manufacturing process (during scale-up entire process). Knowledge agents being useful designing clearance for purification processes engineering facilities.