Veterinary Biological Products of Bacterial Origin

Abstract

The Bacteriology Laboratory is one of the main units within APHIS Veterinary Services' Biologics Laboratories. The Bacteriology Laboratory's responsibilities include the development of valid methods to test biological products for potency or efficacy, safety, purity, and stability. For certain products the need for other factors, i.e., spore counts, cell counts, dissociation, sensitivity, hydrogen ion concentration and preservative content must also be determined.

References and reagents evaluated by Veterinary Services are used in testing by both commercial producers of biologics and in Biofogical Laboratories. Both reagents and reference preparations must be produced and evaluated and some must be standardized with available International Standards. Reagents must be used as an integral part of a test system whereas the use of reference preparations is optional.