Work Package 1

Physicochemical methods for consistency testing

The objective of this work package is to develop and optimise biochemical and physicochemical methods to assess proteome of complex whole cell vaccines and toxoid vaccines and to assess the conformational integrity of toxoid vaccine components in the presence and absence of other active components (e.g. adjuvants).

Partners involved

 

Work Package 2

Immunochemical methods for consistency testing

This work package aims to

  • develop and optimise immunochemical methods for monitoring the consistency of antigen quantity and/or quality throughout the production process,

  • investigate whether the assay is suitable for testing vaccines from multiple different manufacturers and

  • investigate the extent to which in vitro methods are able to detect antigenic changes relevant to the biological functions of vaccines.

 

Partners involved

 

Work Package 3

Cell-based assays for consistency testing

In this work package, the aim is the development, optimization and application of cell-based assays that allow in vitro monitoring of parameters linked to the biological function of vaccines (i.e. capability to induce a protective immune response) or their safety (i.e. absence of toxicity).

 

Partners involved

 

Work Package 4

Multiparametric assays & bioinformatics for consistency testing

The objectives of this work package are:

  • to develop transcriptomics/proteomics technology and identify bacterial biomarkers suitable for characterization of Clostridium tetani seed strains,

  • to develop an alternative for the histamine sensitisation test for Pertussis vaccine safety based on kinome analysis and

  • to develop platform technology and identify biomarkers for the assessment of vaccine quality based on responses of antigen presenting cells to exposure to vaccines/adjuvants in vitro, in support to Work Package 3

 

Partners involved

 

Work Package 5

Validation

This work package wants to accomplish

  • the development of criteria for method development and validation,

  • the design and coordination of validation studies of the methods developed in works packages 123, and and selected by the steering committee,

  • the development of a guidance document for the design of multi-centre validation studies and

  • the preparation of a proposal for multi-centre validation studies under the Biological Standardisation Programme of EDQM.

 

Partners involved

 

Work Package 6

Promotion to regulatory acceptance of consistency testing

In this work package, the partners will

  • define a roadmap for regulatory acceptance of the consistency approach with the goal to provide a basis for guidance on regulatory implementation of new tests developed and

  • facilitate discussion between different stakeholders on specific questions and issues that the introduction of consistency approach might raise.

 

Partners involved

 

Work Package 7

Consortium management

The main objectives of this work package are:

  • the scientific and administrative-financial coordination of the project,

  • to establish effective communication among the consortium partners,

  • to monitor the impact achieved,

  • to establish a dissemination plan and implement the activities foreseen,

  • the ethical oversight of the VAC2VAC project and

  • to identify and appropriately protect intellectual property generated by project.

 

Partners involved