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Vaccine lot to Vaccine lot comparison by consistency testing.

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
Net EU contribution
€ 1 060 437,45
Address
Vossstrasse 2 Geb 4040
69115 Heidelberg
Germany

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Region
Baden-Württemberg Karlsruhe Heidelberg, Stadtkreis
Activity type
Research Organisations
Non-EU contribution
€ 0,00

Participants (24)

RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU
Netherlands
Net EU contribution
€ 247 464,45
Address
Antonie Van Leeuwenhoeklaan 9
3721 MA Bilthoven

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Region
West-Nederland Utrecht Utrecht
Activity type
Research Organisations
Non-EU contribution
€ 0,00
Department of Health
United Kingdom
Net EU contribution
€ 631 405,40
Address
Quarry House, Quarry Hill
LS2 7UE Leeds

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Region
Yorkshire and the Humber West Yorkshire Leeds
Activity type
Research Organisations
Non-EU contribution
€ 0,00
BUNDESINSTITUT FUR IMPFSTOFFE UND BIOMEDIZINISCHE ARZNEIMITTEL
Germany
Net EU contribution
€ 1 000 000,00
Address
Paul-ehrlich-strasse 51-59
63225 Langen

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Region
Darmstadt Offenbach, Landkreis
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION
Belgium
Net EU contribution
€ 228 647,00
Address
Rue De La Loi 200
1049 Brussels

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Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Research Organisations
Non-EU contribution
€ 0,00
UNIVERSITEIT UTRECHT
Netherlands
Net EU contribution
€ 553 000,40
Address
Heidelberglaan 8
3584 CS Utrecht

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Region
West-Nederland Utrecht Utrecht
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
ACADEMISCH ZIEKENHUIS GRONINGEN
Netherlands
Net EU contribution
€ 400 500,00
Address
Hanzeplein 1
9713 GZ Groningen

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Region
Noord-Nederland Groningen Overig Groningen
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT

Participation ended

Netherlands
Net EU contribution
€ 1 052 105,36
Address
Parnassusplein 5
2500 EJ Den Haag

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Region
West-Nederland Zuid-Holland Agglomeratie ’s-Gravenhage
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 0,00
Stichting Hogeschool Utrecht
Netherlands
Net EU contribution
€ 325 000,00
Address
Padualaan 99
3584 CH Utrecht

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Region
West-Nederland Utrecht Utrecht
Activity type
Higher or Secondary Education Establishments
Non-EU contribution
€ 0,00
ISTITUTO SUPERIORE DI SANITA
Italy
Net EU contribution
€ 509 000,00
Address
Viale Regina Elena 299
00161 Roma

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Region
Centro (IT) Lazio Roma
Activity type
Research Organisations
Non-EU contribution
€ 0,00
AGES - OSTERREICHISCHE AGENTUR FUR GESUNDHEIT UND ERNAHRUNGSSICHERHEIT GMBH
Austria
Net EU contribution
€ 512 487,00
Non-EU contribution
€ 0,00
ASSOCIATION INTERNATIONALE DE STANDARDISATION BIOLOGIQUE POUR L'EUROPE(IABS-EU)
France
Net EU contribution
€ 493 187,00
Address
24 Rue Jean Baldassini
69393 Lyon

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Region
Auvergne-Rhône-Alpes Rhône-Alpes Rhône
Activity type
Other
Non-EU contribution
€ 0,00
SCIENSANO
Belgium
Net EU contribution
€ 505 625,00
Address
Juliette Wytsmanstraat 14
1050 Elsene

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Region
Région de Bruxelles-Capitale/Brussels Hoofdstedelijk Gewest Région de Bruxelles-Capitale/ Brussels Hoofdstedelijk Gewest Arr. de Bruxelles-Capitale/Arr. Brussel-Hoofdstad
Activity type
Research Organisations
Non-EU contribution
€ 0,00
STICHTING BIOMEDICAL PRIMATE RESEARCH CENTER
Netherlands
Net EU contribution
€ 305 090,00
Address
Lange Kleiweg 161
2288 GJ Rijswijk Zh

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Region
West-Nederland Zuid-Holland Agglomeratie ’s-Gravenhage
Activity type
Research Organisations
Non-EU contribution
€ 0,00
SANOFI PASTEUR SA
France
Net EU contribution
€ 0,00
Address
14 Espace Henry Vallee
69007 Lyon

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Region
Auvergne-Rhône-Alpes Rhône-Alpes Rhône
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 1 148 632,55
ZOETIS BELGIUM SA
Belgium
Net EU contribution
€ 0,00
Address
Rue Laid Burniat 1
1348 Louvain La Neuve

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Region
Région wallonne Prov. Brabant Wallon Arr. Nivelles
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 1 984 452,40
BOEHRINGER INGELHEIM ANIMAL HEALTH FRANCE
France
Net EU contribution
€ 0,00
Address
29 Avenue Tony Garnier
69007 Lyon

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Region
Auvergne-Rhône-Alpes Rhône-Alpes Rhône
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 417 135,45
BOEHRINGER INGELHEIM VETMEDICA GMBH
Germany
Net EU contribution
€ 0,00
Address
Binger Strasse 173
55218 Ingelheim

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Region
Baden-Württemberg Stuttgart Stuttgart, Stadtkreis
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 479 705,77
INTERVET INTERNATIONAL BV
Netherlands
Net EU contribution
€ 0,00
Address
Wim De Korverstraat 35
5831 AN Boxmeer

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Region
Noord-Brabant Noordoost-Noord-Brabant
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 645 169,50
GLAXOSMITHKLINE BIOLOGICALS SA
Belgium
Net EU contribution
€ 0,00
Address
Rue De L Institut 89
1330 Rixensart

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Region
Région wallonne Prov. Brabant Wallon Arr. Nivelles
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 2 603 333,33
AGENTSCHAP COLLEGE TER BEOORDELING VAN GENEESMIDDELEN
Netherlands
Net EU contribution
€ 0,00
Address
Graadt Van Roggenweg 500
3531AH Utrecht

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Region
West-Nederland Utrecht Utrecht
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Non-EU contribution
€ 312 500,00
PFIZER MANUFACTURING AUSTRIA GMBH

Participation ended

Austria
Net EU contribution
€ 0,00
Address
Uferstrasse 15
2304 Orth An Der Donau

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Region
Niederösterreich Wiener Umland/Nordteil
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 551 000,00
PFIZER LIMITED
United Kingdom
Net EU contribution
€ 0,00
Address
Ramsgate Road
CT13 9NJ Sandwich

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Region
South East (England) Kent East Kent
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 299 000,00
BAVARIAN NORDIC AS
Denmark
Net EU contribution
€ 0,00
Address
Hejreskovvej 10 A
3490 Kvistgard

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Region
Danmark Hovedstaden Nordsjælland
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 82 000,00
INTRAVACC BV
Netherlands
Net EU contribution
€ 26 050,94
Address
Antonie Van Leeuwenhoeklaan 9
3721 MA Bilthoven

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Region
West-Nederland Utrecht Utrecht
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
Non-EU contribution
€ 0,00