title: Evaluation of vaccines, interferons and cell substrates for pestivirus contamination.
abstract: Pestiviruses are potential contaminants of biological products produced in bovine or porcine cells or manufactured via processes using animal-derived raw materials such as bovine serum. In order to investigate possible contamination of products including those manufactured and/or licensed in the US, 38 lots of viral vaccines and five lots of interferon alpha (IFNalpha) were tested by reverse transcriptase polymerase chain reaction (RT-PCR) for the presence of bovine viral diarrhoea virus (BVDV). All vaccines and interferons were negative for contaminating BVDV RNA when tested by RT-PCR, with the exception of an experimental live viral vaccine that had been produced in BVDV contaminated rabbit kidney cells. Cell lines commonly used to produce biological products and vaccines were experimentally infected with the NADL strain of BVDV to determine if they were permissive for virus replication. MRC-5 and WI-38 cells were not infected. In contrast, Vero, CHO and CEF cells showed evidence of pestivirus infection. Taken together these data suggested that currently licensed viral vaccines were unlikely to be contaminated with pestiviruses. However, cell banks derived from non-human primate, hamster or rabbit kidney cell lines, or cultures of primary chick embryo fibroblasts, may be infected with BVDV if exposed to pestivirus contaminated raw materials during manufacture.
authors.affiliation: Laboratory of Pediatrics and Respiratory Viral Diseases, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Bethesda, Maryland 20892, USA.
authors.forename: S A
authors.initials: SA
authors.lastname: Audet
authors.forename: R L
authors.initials: RL
authors.lastname: Crim
authors.forename: J
authors.initials: J
authors.lastname: Beeler
mesh_terms: D000818:Animals; D002417:Cattle; D002460:Cell Line; D002642:Chick Embryo; D002522:Chlorocebus aethiops; D003257:Consumer Product Safety; D006224:Cricetinae; D001908:Diarrhea Viruses, Bovine Viral / Q000235:genetics / Q000302:isolation & purification*; D004340:Drug Contamination; D005069:Evaluation Studies as Topic; D006801:Humans; D016898:Interferon-alpha; D008458:Measles Vaccine; D022542:Measles-Mumps-Rubella Vaccine; D009108:Mumps Vaccine; D011055:Poliovirus Vaccine, Oral; D011817:Rabbits; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000379:methods; D012411:Rubella Vaccine; D017778:Vaccines, Combined; D014709:Vero Cells
chemical_list: D016898:Interferon-alpha; D008458:Measles Vaccine; D022542:Measles-Mumps-Rubella Vaccine; D009108:Mumps Vaccine; D011055:Poliovirus Vaccine, Oral; D012411:Rubella Vaccine; D017778:Vaccines, Combined