Abstract
This chapter provides a historical and up-to-date insight into Three Rs initiatives related to the safety and potency testing of certain biological products, including vaccines, which cannot be fully characterised by chemical or physical methods because of their complex modes of action or manufacturing processes. As a consequence, bioassays in animals were the method of choice in the regulatory procedures laid down to assess product quality. Biological products, which rely on the most severe endpoints, such as the LD50 test (e.g. the safety tests for pertussis and tetanus vaccines and potency tests for therapeutic botulinum toxin) and direct challenge potency tests (e.g. for inactivated vaccines against diphtheria, tetanus and rabies), use the largest number of animals and animals of the highest orders (e.g. monkeys for safety tests on live viral vaccines), were in the frontline of replacement. This chapter considers the progress made toward the elimination of the use of animals for these and other general safety methods involved in the quality control of biologicals.
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