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VAC2VAC SIGNED

Vaccine lot to Vaccine lot comparison by consistancy testing

Total Cost €

0

EC-Contrib. €

0

Partnership

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 VAC2VAC project word cloud

Explore the words cloud of the VAC2VAC project. It provides you a very rough idea of what is the project "VAC2VAC" about.

lot    innovative    release    vitro    quality    consistency    models    animal    ing    validation    vaccine    guidance    vaccines    qc    regulatory    acceptance   

Project "VAC2VAC" data sheet

The following table provides information about the project.

Coordinator
EUROPEAN VACCINE INITIATIVE - EEIG 

Organization address
address: IM NEUENHEIMER FELD
city: Heidelberg
postcode: 69120
website: http://www.euvaccine.eu/

contact info
title: Dr.
name: Odile
surname: Leroy
function: n.a.
email: n.a.
telephone: +49 6221565890
fax: +49 6221565727

 Coordinator Country Germany [DE]
 Total cost 16˙290˙929 €
 EC max contribution 7˙850˙000 € (48%)
 Programme 1. H2020-EU.3.1.7.12. (Vaccine)
 Code Call H2020-JTI-IMI2-2015-03-two-stage
 Funding Scheme /IMI2-RIA
 Starting year 2016
 Duration (year-month-day) from 2016-03-01   to  2021-02-28

 Partnership

Take a look of project's partnership.

# participants  country  role  EC contrib. [€] 
1    EUROPEAN VACCINE INITIATIVE - EEIG DE (Heidelberg) coordinator 1˙060˙437.00
2    MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT NL (DEN HAAG) participant 1˙078˙156.00
3    BUNDESINSTITUT FUR IMPFSTOFFE UND BIOMEDIZINISCHE ARZNEIMITTEL DE (LANGEN) participant 1˙000˙000.00
4    Department of Health england UK (Leeds) participant 631˙405.00
5    UNIVERSITEIT UTRECHT NL (UTRECHT) participant 553˙000.00
6    OSTERREICHISCHE AGENTUR FUR GESUNDHEIT UND ERNAHRUNGSSICHERHEIT GMBH AT (WIEN) participant 512˙487.00
7    INSTITUT SCIENTIFIQUE DE SANTE PUBLIQUE BE (BRUXELLES) participant 505˙625.00
8    ISTITUTO SUPERIORE DI SANITA IT (ROMA) participant 500˙000.00
9    ASSOCIATION INTERNATIONALE DE STANDARDISATION BIOLOGIQUE POUR L'EUROPE (IABS-EU)C FR (LYON) participant 493˙187.00
10    ACADEMISCH ZIEKENHUIS GRONINGEN NL (GRONINGEN) participant 400˙500.00
11    Stichting Hogeschool Utrecht NL (UTRECHT) participant 325˙000.00
12    STICHTING BIOMEDICAL PRIMATE RESEARCH CENTER NL (RIJSWIJK ZH) participant 305˙090.00
13    RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU NL (BILTHOVEN) participant 247˙464.00
14    JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION BE (BRUSSELS) participant 237˙647.00
15    agentschap College ter Beoordeling van Geneesmiddelen NL (UTRECHT) participant 0.00
16    Boehringer Ingelheim Vetmedica GmbH DE (Ingelheim) participant 0.00
17    GlaxoSmithKline Biologicals BE (Rixensart) participant 0.00
18    Intervet International B.V. NL (BOXMEER) participant 0.00
19    MERIAL SAS FR (LYON) participant 0.00
20    SANOFI PASTEUR SA FR (LYON) participant 0.00
21    ZOETIS BELGIUM SA BE (LOUVAIN LA NEUVE) participant 0.00

Mappa

 Project 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.

 Work performed, outcomes and results:  advancements report(s) 

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The information about "VAC2VAC" are provided by the European Opendata Portal: CORDIS opendata.

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