Collective experiences of adventitious viruses of animal-derived raw materials and what can be done about them.

Contamination of animal-derived raw materials with viruses, mycoplasmas, bacteria and fungi is common. These contaminants can interfere with the diagnosis of viral infection, and vaccines produced using infected cell cultures could lead to seroconversion or disease in the vaccinated animal. The purity, safety and efficacy of viral vaccines requires testing of the ingredients, cell substrates and final product.

Development of monoclonal antibodies suitable for use in antigen quantification potency tests for clostridial veterinary vaccines.

The quality control testing of clostridial veterinary vaccines currently requires large numbers of animals. Alternative in vitro test methods are being investigated by researchers in industry and by regulatory authorities in many countries. Monoclonal antibodies that neutralize Clostridium perfringens alpha toxin, C.

Benefits and risks due to animal serum used in cell culture production.

Infection with bovine viral diarrhoea virus (BVDV) and other viruses is frequent in the bovine population. In utero infection leads to virus and antibody contamination of foetal and other serum used in cell culture production. The use of contaminated cells for vaccine production may result in contaminated vaccines, which may lead to seroconversion or disease in the vaccinated animal.

Quantitation of commercial equine tetanus antitoxin by competitive enzyme-linked immunosorbent assay.

In the USA, the potency of commercially prepared equine tetanus antitoxin is determined by the method outlined in the Code of Federal Regulations, Title 9, Part 113.451. In the current test, commercial equine tetanus antitoxin is tested by a toxin neutralization test in guinea pigs.