Vaccine batch to vaccine batch comparison by consistency testing
RIVM contributes to VAC2VAC, a public-private consortium with 20 partners, including regulatory authorities, research institutes and industry. The aim of VAC2VAC is to develop and validate non-animal tests to determine the quality of human and veterinary vaccines, in support of the consistency approach.
Vaccines are produced in batches. Regulatory authorities require that the efficacy and safety of each batch of vaccines are tested. The testing of some vaccines requires large numbers of animals. However, the production of vaccines is becoming increasingly controlled, there is improved control on the quality of starting materials and improved in-process controls. The principle of the "consistency approach" is that the reproducibility of the production process is such that test animals are no longer needed for the release of batches of vaccines.
The focus of testing has shifted from the batch to the production process. Instead of laboratory animals, in the consistency approach, physico-chemical and immunochemical determinations can be used for the release of batches of vaccines. In addition, in vitro tests based on cells of the immune system of the species for which the vaccine is intended can be used to test the quality of the vaccine in generating an adequate vaccination response. These methods are being developed in the VAC2VAC project and, together with all partners in the project, the aim is to use them for acceptance of the consistency approach to vaccine quality control.
The VAC2VAC project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement N- 115924. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA.