The Consistency Approach to Quality Control in Vaccine Manufacture

Specific Challenge  The final lot testing for safety and potency of established vaccines often suffers from inaccuracies due to the inherent variability of the animal tests used. Recent advances in quality and process control and modern vaccines of well-defined composition suggest that quality and safety control of the final product may be possible without in vivo safety and potency testing. Scope The Consistency Approach is a new paradigm for improved quality control of vaccines aiming at an integrated quality monitoring programme during vaccine lot production using non-animal methods. The main objective is to demonstrate the proof-of-concept of this new paradigm and its relevance to both the human and veterinary vaccine sectors. Expected Impact

It is expected that achieving the main objective would lead to an agreed road map for translating the Consistency Approach into regulatory guidance. In addition the project could contribute to the access to medicines, reducing lead time and cost, improving R&D processes beyond vaccine manufacturing.

Budget

IMI contribution:                        EUR 7 850 000

EFPIA contribution:                   EUR 7 850 000

Total:                                       EUR 15 700 000