Evaluation of the human host range of bovine and porcine viruses that may contaminate bovine serum and porcine trypsin used in the manufacture of biological products

作者: Carol Marcus-Sekura , James C. Richardson , Rebecca K. Harston , Nandini Sane , Rebecca L. Sheets

DOI: 10.1016/J.BIOLOGICALS.2011.08.003

关键词: TrypsinPotential riskBiologyPorcine parvovirusPorcine TrypsinVirus Physiological PhenomenaImmunofluorescenceVirologyVirus classificationBovine serum albuminBiotechnologyGeneral Immunology and MicrobiologyApplied Microbiology and BiotechnologyBioengineeringPharmacologyGeneral Medicine

摘要: Current U.S. requirements for testing cell substrates used in production of human biological products contamination with bovine and porcine viruses are Department Agriculture (USDA) 9CFR tests serum or trypsin. requires seven specific six families (immunofluorescence) at least 2 additional non-specifically (cytopathicity hemadsorption). trypsin is parvovirus. Recent contaminations suggest these may not be sufficient. Assay sensitivity was the issue that were caused by viruses/virus represented screen. A detailed literature search undertaken to determine which infect cattle swine cells culture also have host range [ability humans culture] predict their detection currently procedures. There more potential risk manufactured using raw materials than likely detected procedures; even within families, all members would necessarily detected. Testing gaps alternative methodologies should evaluated continue ensure safe, high quality biologicals.

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