VAC2VAC

Vaccine batch to vaccine batch comparison by consistency testing

Background

VAC2VAC is a wide-ranging collaborative research project funded by IMI2 which aims to develop and validate quality testing approaches for both human and veterinary vaccines using non-animal methods.  The initiative aims to provide the data to support the "consistency approach" for quality control of established vaccines.  The current quality control approach for final products relies on in vivo methods.

VAC2VAC is a public-private consortium of twenty partners, involving experts from veterinary and human vaccine industry in a partnership with official medicines control laboratories, academia, translational research organisations, and vaccinology alliances.  To achieve their goal, the project partners will develop, optimise and evaluate physiochemical and immunochemical methods, cell-based and other assays for routine batch quality, safety and efficacy testing of vaccines.  This will be done in collaboration and consultation with regulatory agencies.

The project is organised into seven work packages:

WP 1: Physiochemical methods for consistency testing

WP 2: Immunochemical methods for consistency testing

WP 3: Cell-based assays for consistency testing

WP 4: Multiparametric assays & bioinformatics

WP 5: Validation

WP 6: Promotion to regulatory acceptance of consistency testing

WP 7: Consortium management

Objectives

The overall ambition of the VAC2VAC project is

  1. to develop and validate non-animal tests for final batch release testing,
  2. to generate vaccine specific toolkits of consistency tests with clearly defined acceptance criteria for batch quality assessment,
  3. to increase scientific understanding of vaccine quality and the factors affecting quality that are critical to ensure consistency with batches of proven safety and efficacy, and
  4. to contribute to regulatory acceptance and routine use of the non-animal tests for batch final release testing.

Ultimately, the project aims to develop tests and approaches that will allow acceptance of the "consistency approach" for existing vaccines by the regulatory agencies and thereby significantly reducing in the future the use of animals for batch testing in routine vaccine production.

Milestones

  • The kick-off meeting of the VAC2VAC project took place in Brussels on the 22 and 23 March 2016.

VAC2VAC kick-off meeting

Participants of the VAC2VAC kick-off meeting in Brussels, Belgium in March 2016