The JRC's EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) organised this workshop with VAC2VAC partners from the 30th January to the 1st February 2017 to discuss ways of improving multi-centre validation studies and making use of the data generated for product-specific validation purposes.
The VAC2VAC project aims to develop and validate non-animal based methods for the quality control of vaccines. In order to incorporate a new method into a monograph or a guideline used for regulatory purposes, the method has to be shown to be reproducible and to have the ability to detect vaccine batches of inferior quality. Moreover, any new method introduced for the quality control of a vaccine needs to undergo product-specific validation. Both multi-centre validation studies and product-specific validation are technically demanding and time and resource intensive. In the light of this, the workshop focused on ways of improving multi-centre validation studies and making use of the data generated for product-specific validation purposes.
The workshop was held at JRC (Ispra, Italy) and involved 30 experts from veterinary and human vaccine manufacturers, official medicines control laboratories, academia, translational research organisations, and vaccinology alliances. The summary of the discussions and recommendations will be published during 2017.