Bovine & Porcine Assays
One of the risks during the production of a viral vaccine or biologic is contamination arising through the introduction of virus from reagents derived from animal material such as bovine serum or porcine trypsin. The risk these agents pose has been well documented and there are guidelines both in the USA and Europe which describe the methods to be used to test these raw materials.
Bovine Virus Detection
The Code of Federal Regulations (9CFR) has a guideline for the testing of bovine serum in the production of a biologic. The regulation lists the specific viruses which could contaminate a serum batch: Bovine viral diarrhoea virus (BVDV), Bovine adenovirus type 5 (BAdV5), Bovine parvovirus (BPV), Bluetongue virus (BTV), Bovine respiratory syncytial virus (BRSV), Rabies virus, Reovirus type 3 (REO-3) and Bovine Parainfluenza type 3 virus (BPiV3). BioOutsource offers the detection of these bovine viruses by a sensitive PCR assay.
The European regulations for the testing for bovine virus contamination also requires examination for Bovine polyoma virus which BioOutsource offers as a sensitive PCR assay.
Porcine Virus Detection
The Code of Federal Regulations (9CFR) has a guideline for the testing of porcine derived products in the production of a biologic. The regulation lists the specific viruses which could contaminate a batch: Bovine viral diarrhoea virus (BVDV), Rabies virus, Reovirus, Porcine Parvovirus (PPV), Porcine Adenovirus (PAdV), Porcine Transmissible Gastroenteritis virus (PTGV) and Porcine haemagglutinating encephalomyelitis virus (PHEV). The guideline also notes that if the porcine derived material is trypsin (which is common in recombinant protein production) then the testing requirement is only for Porcine parvovirus. BioOutsource offers the detection of these viruses by a sensitive PCR assay.
Contact our biosafety scientists to discuss your testing requirements.