In vitro potency testing of inactivated biologics: current situation in the E.E.C.

Abstract A whole series of regulations are currently being implemented in the European Economic Community in the field of biologics that are complementing the European Pharmacopoeia and widening its field of application. The object of these new regulations is to ensure a very high level of safety and efficacy, but unfortunately, they tend towards the increased use of animals for testing purpose. However, for ethical, economic and practical reasons, the number of animals used must be reduced which makes the development of in vitro tests an important issue. In vitro testing is complicated since inactivated products are often adsorbed onto aluminum hydroxide or presented as an emulsion, and tests are easier to carry out prior to final blending operations. It is suggested that in-process controls can replace finished product controls when batch-to-batch consistency has been formerly validated, a quality assurance system has been adopted, and that system is regularly subjected to a suitable inspection procedure. The new inspection system applied in the United Kingdom should facilitate progress in this field and lead to a parametric release system. To avoid future problems, it is particularly important that efforts be made now for the harmonization of new techniques between Europe and the United States.