Bovine Virus Testing

PCR and fluorescent antibody panels of viruses used in our testing in compliance with the Code of Federal Regulations (9 CFR, parts 113.46 and 113.47), Animals and Animal Products. The panel includes the 10 viruses listed below. Clients may request the inclusion of other viruses or modification of our standard protocols, as desired.

The test begins with bovine turbinate (BT) and Vero cells, which are susceptible to a wider range of viruses. These cells are inoculated with the test sample and cultured for at least 21 days. At least 14 days after inoculation, monolayers are prepared from test cultures for end-point analysis.

To serve as negative controls, cultures of BT and Vero cells inoculated with culture medium are maintained in parallel with test cultures. Similarly, other monolayers are prepared from test cultures at least 14 days after inoculation; these are inoculated with positive control viruses and likewise maintained in parallel. As a final result, we report whether any of these viruses are found. Reporting time for bovine 9 CFR testing is 5 weeks.

PCR: The following PCR assays are available to detect bovine and Porcine viral pathogens:

1. Bovine viral diarrhea virus (BVDV)
2. Bovine Polyoma virus“
3. Blue tongue (BTV)
4. Bovine adenovirus (BAV)
5. Bovine herpesvirus
6. Bovine parvovirus (BPV)
7. Porcine Parvovirus (PPV)
8. Bovine respiratory syncytial virus (BRSV)
9. Reovirus 3
10. Rabies

Specific test (fluorescent antibody) for:

1. Bovine viral diarrhea virus (BVDV)
2. Blue tongue (BTV)
3. Bovine adenovirus (BAV)
4. Bovine parvovirus (BPV)
5. Bovine respiratory syncytial virus (BRSV)
6. Reovirus 3
7. Rabies

Bovine Viral Diarrhea Virus (BVDV) is a highly prevalent infection in cattle and its presence in bovine serum cannot be completely avoided. The potential presence of extraneous agents in bovine serum represents a risk to the safety of the biological medicinal product. The testing and removal of BVDV is essential to control the quality and safety of bovine serum used during the manufacture of human biological medicinal products for human and animal use including vaccines, bovine serum and master cell banks. Testing for BVDV is performed throughout the manufacturing process specifically on serum used during production cell growth and during cell growth prior to a production phase (growth of cell prior to vaccine production).

Bovine Polyoma virus (BPyV) Bovine polyoma virus is a common contaminant of bovine serum. Serum manufacturers and users are encouraged to apply infectivity assays for BPyV and to investigate methods for inactivation/removal of BPyV in order to limit or eliminate infectious virus from batches of serum.

Electron microscopy.

Pelleted cell lines are chemically fixed, embedded in epoxy resin and thin-sections are prepared. A minimum of fifty cell sections from each cell line are examined for the presence of viral particles at 5,000 X-50,000 X magnification in a transmission electron microscope.

Associated services

1. Endotoxin testing
2. Virucidal and antimicrobial efficacy studies
3. Environmental monitoring
4. Package stability and validation
5. Water validations
6. Contract manufacturing

Custom Assays. We understand that no production plant is identical and that every process is unique. Using a combination of practical experience and a scientific approach, we will customize bovine virus testing methods to meet your specific requirements including scientifically sound data that will be accepted by regulatory authorities around the globe.