IN-VITRO POTENCY TESTING OF INACTIVATED BIOLOGICS - CURRENT SITUATIONIN THE EEC

A whole series of regulations are currently being implemented in the E uropean Economic Community in the field of biologics that are compleme nting the European Pharmacopoeia and widening its field of application . The object of these new regulations is to ensure a very high level o f safety and efficacy, but unfortunately, they tend towards the increa sed use of animals for testing purposes. However, for ethical, economi c and practical reasons, the number of animals used must be reduced wh ich makes the development of in vitro tests an important issue. In vit ro testing is complicated since inactivated products are often adsorbe d onto aluminum hydroxide or presented as an emulsion, and tests are e asier to carry out prior to final blending operations. It is suggested that in-process controls can replace finished product controls when b atch-to-batch consistency has been formerly validated, a quality assur ance system has been adopted, and that system is regularly subjected t o a suitable inspection procedure. The new inspection system applied i n the United Kingdom should facilitate progress in this field and lead to a parametric release system. To avoid future problems, it is parti cularly important that efforts be made now for the harmonization of ne w techniques between Europe and the United States.