Immunoelectrophoresis in quality control of veterinary clostridial products

Each year the pharmaceutical industry produces 150-250 batches of anti-Clostridial vaccines and sera for veterinary use in the U.K. Under Medicines Act requirements these products must be tested for potency before release to the public, such tests being performed in animals. The Ministry of Agriculture, as licensing authority, also carries out potency test on representative samples of these products. To avoid unnecessary use of animals we employ immunoelectrophoresis (IEP) as a screening test. Results obtained so far show a close correlation between values obtained by IEP and the statutory tests and offer a potential alternative to the use of animals in potency tests.