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: Trypsin 、 Potential risk 、 Biology 、 Porcine parvovirus 、 Porcine Trypsin 、 Virus Physiological Phenomena 、 Immunofluorescence 、 Virology 、 Virus classification 、 Bovine serum albumin 、 Biotechnology 、 General Immunology and Microbiology 、 Applied Microbiology and Biotechnology 、 Bioengineering 、 Pharmacology 、 General 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.