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VAC2VAC SIGNED

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

Total Cost €

EC-Contrib. €

Partnership

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Outcomes and
results

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.

ranging market vaccine assays quality training groups proven competitiveness fundamental welfare acceptance shortened academia of models validation decades multiple safety consistency regulatory alliances workshops vitro optimise reflect roadmap technologies policies bioinformatics efficacy time industries innovative lot qc ago promoted complementary validate stakeholder manufacturing similarity ing ambition categories vaccinology expertise proof tight strategic place institutes days vaccines release courses translational profiles enhanced cell demonstrated wps guidance techniques substantial animal relies omcls vac2vac promotion analytical conference

Project "VAC2VAC" data sheet

The following table provides information about the project.

Coordinator	EUROPEAN VACCINE INITIATIVE EWIV Organization address address: VOSSSTRASSE 2 GEB 4040 city: HEIDELBERG postcode: 69115 website: http://www.euvaccine.eu/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.
Coordinator Country	Germany [DE]
Project website	http://www.vac2vac.eu
Total cost	16˙290˙929 €
EC max contribution	7˙850˙000 € (48%)
Programme	1. H2020-EU.3.1.7. (Innovative Medicines Initiative 2 (IMI2))
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 EWIV EUROPEAN VACCINE INITIATIVE EWIV Organization address address: VOSSSTRASSE 2 GEB 4040 city: HEIDELBERG postcode: 69115 website: http://www.euvaccine.eu/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (HEIDELBERG)	coordinator	1˙060˙437.00
2	MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT Organization address address: PARNASSUSPLEIN 5 city: DEN HAAG postcode: 2500 EJ website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (DEN HAAG)	participant	1˙078˙156.00
3	BUNDESINSTITUT FUR IMPFSTOFFE UND BIOMEDIZINISCHE ARZNEIMITTEL BUNDESINSTITUT FUR IMPFSTOFFE UND BIOMEDIZINISCHE ARZNEIMITTEL Organization address address: PAUL-EHRLICH-STRASSE 51-59 city: LANGEN postcode: 63225 website: www.pei.de contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (LANGEN)	participant	1˙000˙000.00
4	Department of Health Department of Health Organization address address: Quarry House, Quarry Hill city: Leeds postcode: LS2 7UE website: www.dh.gov.uk contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	UK (Leeds)	participant	631˙405.00
5	UNIVERSITEIT UTRECHT UNIVERSITEIT UTRECHT Organization address address: HEIDELBERGLAAN 8 city: UTRECHT postcode: 3584 CS website: www.uu.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (UTRECHT)	participant	553˙000.00
6	OSTERREICHISCHE AGENTUR FUR GESUNDHEIT UND ERNAHRUNGSSICHERHEIT GMBH OSTERREICHISCHE AGENTUR FUR GESUNDHEIT UND ERNAHRUNGSSICHERHEIT GMBH Organization address address: SPARGELFELDSTRASSE 191 city: WIEN postcode: 1220 website: www.ages.at contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	AT (WIEN)	participant	512˙487.00
7	SCIENSANO SCIENSANO Organization address address: JULIETTE WYTSMANSTRAAT 14 city: ELSENE postcode: 1050 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (ELSENE)	participant	505˙625.00
8	ISTITUTO SUPERIORE DI SANITA ISTITUTO SUPERIORE DI SANITA Organization address address: Viale Regina Elena 299 city: ROMA postcode: 161 website: http://www.iss.it contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	IT (ROMA)	participant	500˙000.00
9	ASSOCIATION INTERNATIONALE DE STANDARDISATION BIOLOGIQUE POUR L'EUROPE (IABS-EU) ASSOCIATION INTERNATIONALE DE STANDARDISATION BIOLOGIQUE POUR L'EUROPE (IABS-EU) Organization address address: BOULEVARTD VIVIER MERLE 10-12 WORLD TRADE CENTER TOUR OXYGENE city: LYON postcode: 69393 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (LYON)	participant	493˙187.00
10	ACADEMISCH ZIEKENHUIS GRONINGEN ACADEMISCH ZIEKENHUIS GRONINGEN Organization address address: HANZEPLEIN 1 city: GRONINGEN postcode: 9713 GZ website: www.umcg.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (GRONINGEN)	participant	400˙500.00
11	Stichting Hogeschool Utrecht Stichting Hogeschool Utrecht Organization address address: PADUALAAN 99 city: UTRECHT postcode: 3584 CH website: www.hu.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (UTRECHT)	participant	325˙000.00
12	STICHTING BIOMEDICAL PRIMATE RESEARCH CENTER STICHTING BIOMEDICAL PRIMATE RESEARCH CENTER Organization address address: LANGE KLEIWEG 161 city: RIJSWIJK ZH postcode: 2288 GJ website: www.bprc.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (RIJSWIJK ZH)	participant	305˙090.00
13	RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU Organization address address: Antonie Van Leeuwenhoeklaan 9 city: BILTHOVEN postcode: 3721 MA website: www.rivm.nl contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (BILTHOVEN)	participant	247˙464.00
14	JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION Organization address address: Rue de la Loi 200 city: BRUSSELS postcode: 1049 website: http://www.jrc.ec.europa.eu contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (BRUSSELS)	participant	237˙647.00
15	AGENTSCHAP COLLEGE TER BEOORDELING VAN GENEESMIDDELEN AGENTSCHAP COLLEGE TER BEOORDELING VAN GENEESMIDDELEN Organization address address: GRAADT VAN ROGGENWEG 500 city: UTRECHT postcode: 3531AH website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (UTRECHT)	participant	0.00
16	BOEHRINGER INGELHEIM VETMEDICA GMBH BOEHRINGER INGELHEIM VETMEDICA GMBH Organization address address: BINGER STRASSE 173 city: INGELHEIM postcode: 55218 website: www.boehringer-ingelheim.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	DE (INGELHEIM)	participant	0.00
17	GLAXOSMITHKLINE BIOLOGICALS SA GLAXOSMITHKLINE BIOLOGICALS SA Organization address address: RUE DE L INSTITUT 89 city: RIXENSART postcode: 1330 website: www.gskbio.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (RIXENSART)	participant	0.00
18	INSTITUT SCIENTIFIQUE DE SANTE PUBLIQUE INSTITUT SCIENTIFIQUE DE SANTE PUBLIQUE Organization address address: Rue Juliette Wytsman 14 city: BRUXELLES postcode: 1050 website: www.iph.fgov.be contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (BRUXELLES)	participant	0.00
19	INTERVET INTERNATIONAL BV INTERVET INTERNATIONAL BV Organization address address: WIM DE KORVERSTRAAT 35 city: BOXMEER postcode: 5831 AN website: http://www.intervet.com/ contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	NL (BOXMEER)	participant	0.00
20	MERIAL SAS MERIAL SAS Organization address address: AVENUE TONY GARNIER 29 city: LYON postcode: 69007 website: www.merial.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (LYON)	participant	0.00
21	PFIZER MANUFACTURING AUSTRIA GMBH PFIZER MANUFACTURING AUSTRIA GMBH Organization address address: UFERSTRASSE 15 city: ORTH AN DER DONAU postcode: 2304 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	AT (ORTH AN DER DONAU)	participant	0.00
22	SANOFI PASTEUR SA SANOFI PASTEUR SA Organization address address: Avenue Pont Pasteur, 2 city: LYON postcode: 69007 website: www.sanofipasteur.com contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	FR (LYON)	participant	0.00
23	ZOETIS BELGIUM SA ZOETIS BELGIUM SA Organization address address: RUE LAID BURNIAT 1 city: LOUVAIN LA NEUVE postcode: 1348 website: n.a. contact info title: n.a. name: n.a. surname: n.a. function: n.a. email: n.a. telephone: n.a. fax: n.a.	BE (LOUVAIN LA NEUVE)	participant	0.00

Map

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

Deliverables

List of deliverables.
Project meetings and conferences.	Other	2020-03-24 16:36:20
Establishment of SEAC.	Other	2020-03-24 16:36:20
Preparation of communication material including launch of project webpage.	Websites, patent fillings, videos etc.	2020-03-24 16:36:20

Take a look to the deliverables list in detail: detailed list of VAC2VAC deliverables.

Publications

List of publications.
year	authors and title	journal	last update
2018	Marlies Halder, Hilde Depraetere, FrÃ©dÃ©rique Delannois, Arnoud Akkermans, Marie-Emmanuelle Behr-Gross, Martijn Bruysters, Jean-FranÃ§ois Dierick, Carmen JungbÃ¤ck, Imke Kross, Bernard Metz, Jeroen Pennings, Peter Rigsby, Patrice Riou, Elisabeth Balks, Alexandre Dobly, Odile Leroy, Catrina Stirling Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies published pages: 78-82, ISSN: 1045-1056, DOI: 10.1016/j.biologicals.2018.01.003	Biologicals 52	2020-03-24

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