VAC2VAC – Vaccine batch to vaccine batch comparison by consistency testing
After the VAC2VAC project was started in March 2016, the first annual meeting was held at the Paul-Ehrlich-Institut on 9 and on 10 March 2017. VAC2VAC is a consortium composed of both public and private members. It consists of 20 partners including pharmaceutical manufacturers of vaccines for human and veterinary use, academic institutes, and regulatory authorities. The aim of VAC2VAC is to create a platform for the development, validation, and regulatory assessment of test systems for vaccines that do not use animals.
VAC2VAC focuses on developing physicochemical, immunochemical and cell based methods for the testing of vaccines also employing genomic and metabolomic analyses. These animal-free analytical methods are intended to monitor the consistent quality, efficacy, and safety of vaccine batches. This approach, also known as 'Consistency Approach' relies on the comparison of product profiles with a reference batch of known safety and efficacy. The consistent production of vaccines and the close monitoring of the manufacturing process are an integral part of the Consistency Approach. The new test methods are also expected to be of use for 'in process controls'. Experts of the PEI from the divisions Microbiology, Veterinary Medicine, and Allergology are committed to VAC2VAC to improve test methods for diphtheria, pertussis, tetanus, or Leptospira vaccines. In addition, regulatory experts contribute to the advancement of guidelines on the validation and the implementation of new methods.
VAC2VAC is financed for five years by the 'Innovative Medicines Initiative' (IMI2), a joint initiative of the European Union and the European Federation of Pharmaceutical Industries and Associations.
On the occasion of their annual meeting, the partners contributing to VAC2VAC discussed the progress of the overall project and its strategic and methodical details. They also prepared a roadmap for the next year.