Session I-7: Potency and safety testing of veterinary vaccines Session I-7: Oral presentations

Veterinary vaccines in North America are regulated to assure that they are safe, pure, potent and effective. the veterinary biologics industry conducts a number of in vivo and in vitro assays as part of the vaccine development and manufacturing process to assure that vaccines conform to these requirements. the batch or serial release safety test is one such assay. the serial release safety tests are conducted using a combination of target and/or laboratory animals for every batch of vaccine prior to its release for commercial distribution. In an effort to reduce the number of animals required for the production of veterinary vaccines, industry and regulators are working together to evaluate alternatives to in vivo safety testing for batch release. Factors under consideration in developing a regulatory framework that would reduce these in vivo tests include: consistency of the production process (GMP or equivalent), review of the safety profile during vaccine development (field and laboratory trials), historical in vivo batch safety test results, vaccinovigilance programs, the impact of future production process changes, the potential for additional in vitro testing requirements, and the implementation of additional production constraints. In addition to the required changes in domestic regulations, to effectively reduce the numbers of in vivo tests required by industry to assure batch safety in the current global marketing environment, these regulatory changes will also require harmonization across all markets requiring the in vivo testing. I-7-257 The reduction of animal-based safety testing of veterinary vaccines