Towards eliminating the use of animals for regulatory required vaccine quality control.

Traditionally, regulatory required vaccine quality control relies on the use of laboratory animals. Both batch testing for safety and testing for potency are based on animal models. Quite often these models include procedures that induce severe pain and suffering. This has urged the development of 3Rs methods. Some examples of recent achievements in the quality control of toxoid vaccines are the replacement of challenge procedures by serological methods, the reduction of numbers of animals required by changing from multi-dose to single dose testing, and developments in the area of in vitro models and physicochemical techniques. Central in the progress towards the elimination of animal use is the acceptance of the so-called consistency approach. The essence of the consistency approach is that a new batch of vaccine is no longer seen as a unique product but as only one of a series of batches produced from the same starting material (seed lot). Consequently, the new batch shares many of the characteristics of the previous batches produced from the same seed lot. This allows for a new strategy of vaccine quality control consisting of demonstrating consistency in production, placing emphasis on aspects such as in-process testing, and implementing Good Manufacturing Practice and Quality Assurance (QA). The new strategy particularly focuses on non-animal test models such as physicochemical methods and in vitro models. Implementation of the consistency approach might significantly contribute towards the elimination of the use of animals in regulatory required vaccine quality control.