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Vaccine lot to Vaccine lot comparison by consistancy testing - Sofia ref.: 115924

Vaccine lot to Vaccine lot comparison by consistancy testing - Sofia ref.: 115924

Objective

Lot release testing of established vaccines relies on using animal models. Many of these models were developed decades ago and reflect the level of product knowledge, production technology and quality management in those days. Current production techniques are optimised, in-process control is implemented and tight quality management systems are in place. These developments have brought testing for lot-to-lot consistency into reach. The consistency approach involves the use of a set of parameters obtained by using innovative in vitro technologies, to define the product along the manufacturing pathway and to ensure similarity to a lot of proven efficacy and safety.

The ambition of the VAC2VAC project is a demonstrated proof of concept of the consistency approach for lot release testing. We will develop/optimise and validate innovative in vitro methods for the categories of established vaccines on the market. Product profiles will be defined using analytical methods, cell-based assays and bioinformatics.

The project includes 7 WPs: 4 on R&D, and one each on validation, promotion to regulatory acceptance and consortium management. Consortium partners represent the vaccine stakeholder groups (OMCLs, Academia, Translational research institutes and Vaccinology alliances) and are complementary for the expertise ranging from method development and validation to facilitating and providing guidance to regulatory acceptance. Acceptance will be promoted by strategic guidance activities: a roadmap conference, workshops and training courses. Implementation of the consistency approach in lot release testing has multiple impact: 1) strengthening fundamental understanding of vaccine products resulting in enhanced understanding of vaccine quality 2) strengthening competitiveness of European Vaccine Industries resulting in
reduced QC costs and shortened QC time. 3) strengthening European animal welfare policies resulting in a substantial reduction in animal numbers for vaccine QC

Coordinator

EUROPEAN VACCINE INITIATIVE EWIV

Address

Vossstrasse 2 Geb 4040
69115 Heidelberg

Germany

Activity type

Research Organisations

EU Contribution

€ 1 060 437,45

Participants (22)

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RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU

Netherlands

EU Contribution

€ 247 464,45

Department of Health

United Kingdom

EU Contribution

€ 631 405,40

BUNDESINSTITUT FUR IMPFSTOFFE UND BIOMEDIZINISCHE ARZNEIMITTEL

Germany

EU Contribution

€ 1 000 000

JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION

Belgium

EU Contribution

€ 237 647

UNIVERSITEIT UTRECHT

Netherlands

EU Contribution

€ 553 000,40

ACADEMISCH ZIEKENHUIS GRONINGEN

Netherlands

EU Contribution

€ 400 500

MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT

Netherlands

EU Contribution

€ 1 078 156,30

Stichting Hogeschool Utrecht

Netherlands

EU Contribution

€ 325 000

ISTITUTO SUPERIORE DI SANITA

Italy

EU Contribution

€ 500 000

OSTERREICHISCHE AGENTUR FUR GESUNDHEIT UND ERNAHRUNGSSICHERHEIT GMBH

Austria

EU Contribution

€ 512 487

ASSOCIATION INTERNATIONALE DE STANDARDISATION BIOLOGIQUE POUR L'EUROPE (IABS-EU)

France

EU Contribution

€ 493 187

INSTITUT SCIENTIFIQUE DE SANTE PUBLIQUE

Belgium

SCIENSANO

Belgium

EU Contribution

€ 505 625

STICHTING BIOMEDICAL PRIMATE RESEARCH CENTER

Netherlands

EU Contribution

€ 305 090

SANOFI PASTEUR SA

France

ZOETIS BELGIUM SA

Belgium

MERIAL SAS

France

BOEHRINGER INGELHEIM VETMEDICA GMBH

Germany

Intervet International B.V.

Netherlands

GLAXOSMITHKLINE BIOLOGICALS SA

Belgium

AGENTSCHAP COLLEGE TER BEOORDELING VAN GENEESMIDDELEN

Netherlands

PFIZER MANUFACTURING AUSTRIA GMBH

Austria

Project information

Grant agreement ID: 115924

Status

Ongoing project

  • Start date

    1 March 2016

  • End date

    28 February 2021

Funded under:

H2020-EU.3.1.7.12.

  • Overall budget:

    € 16 290 929

  • EU contribution

    € 7 850 000

Coordinated by:

EUROPEAN VACCINE INITIATIVE EWIV

Germany