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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

Field of science

  • /social sciences/economics and business/business and management/commerce
  • /medical and health sciences/basic medicine/pharmacology and pharmacy/pharmaceutical drug/vaccines

Call for proposal

H2020-JTI-IMI2-2015-03-two-stage
See other projects for this call

Funding Scheme

IMI2-RIA - Research and Innovation action

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)

RIJKSINSTITUUT VOOR VOLKSGEZONDHEID EN MILIEU
Netherlands
EU contribution
€ 247 464,45
Address
Antonie Van Leeuwenhoeklaan 9
3721 MA Bilthoven
Activity type
Research Organisations
Department of Health
United Kingdom
EU contribution
€ 631 405,40
Address
Quarry House, Quarry Hill
LS2 7UE Leeds
Activity type
Research Organisations
BUNDESINSTITUT FUR IMPFSTOFFE UND BIOMEDIZINISCHE ARZNEIMITTEL
Germany
EU contribution
€ 1 000 000
Address
Paul-ehrlich-strasse 51-59
63225 Langen
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
JRC -JOINT RESEARCH CENTRE- EUROPEAN COMMISSION
Belgium
EU contribution
€ 237 647
Address
Rue De La Loi 200
1049 Brussels
Activity type
Research Organisations
UNIVERSITEIT UTRECHT
Netherlands
EU contribution
€ 553 000,40
Address
Heidelberglaan 8
3584 CS Utrecht
Activity type
Higher or Secondary Education Establishments
ACADEMISCH ZIEKENHUIS GRONINGEN
Netherlands
EU contribution
€ 400 500
Address
Hanzeplein 1
9713 GZ Groningen
Activity type
Higher or Secondary Education Establishments
MINISTERIE VAN VOLKSGEZONDHEID, WELZIJN EN SPORT
Netherlands
EU contribution
€ 1 078 156,30
Address
Parnassusplein 5
2500 EJ Den Haag
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
Stichting Hogeschool Utrecht
Netherlands
EU contribution
€ 325 000
Address
Padualaan 99
3584 CH Utrecht
Activity type
Higher or Secondary Education Establishments
ISTITUTO SUPERIORE DI SANITA
Italy
EU contribution
€ 500 000
Address
Viale Regina Elena 299
00161 Roma
Activity type
Research Organisations
OSTERREICHISCHE AGENTUR FUR GESUNDHEIT UND ERNAHRUNGSSICHERHEIT GMBH
Austria
EU contribution
€ 512 487
Address
Spargelfeldstrasse 191
1220 Wien
Activity type
Research Organisations
ASSOCIATION INTERNATIONALE DE STANDARDISATION BIOLOGIQUE POUR L'EUROPE(IABS-EU)
France
EU contribution
€ 493 187
Address
Boulevartd Vivier Merle 10-12 World Trade Center Tour Oxygene
69393 Lyon
Activity type
Other
INSTITUT SCIENTIFIQUE DE SANTE PUBLIQUE

Participation ended

Belgium
EU contribution
€ 0
Address
Rue Juliette Wytsman 14
1050 Bruxelles
Activity type
Research Organisations
SCIENSANO
Belgium
EU contribution
€ 505 625
Address
Juliette Wytsmanstraat 14
1050 Elsene
Activity type
Research Organisations
STICHTING BIOMEDICAL PRIMATE RESEARCH CENTER
Netherlands
EU contribution
€ 305 090
Address
Lange Kleiweg 161
2288 GJ Rijswijk Zh
Activity type
Research Organisations
SANOFI PASTEUR SA
France
EU contribution
€ 0
Address
Avenue Pont Pasteur, 2
69007 Lyon
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
ZOETIS BELGIUM SA
Belgium
EU contribution
€ 0
Address
Rue Laid Burniat 1
1348 Louvain La Neuve
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
MERIAL SAS
France
EU contribution
€ 0
Address
Avenue Tony Garnier 29
69007 Lyon
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
BOEHRINGER INGELHEIM VETMEDICA GMBH
Germany
EU contribution
€ 0
Address
Binger Strasse 173
55218 Ingelheim
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
INTERVET INTERNATIONAL BV
Netherlands
EU contribution
€ 0
Address
Wim De Korverstraat 35
5831 AN Boxmeer
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
GLAXOSMITHKLINE BIOLOGICALS SA
Belgium
EU contribution
€ 0
Address
Rue De L Institut 89
1330 Rixensart
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)
AGENTSCHAP COLLEGE TER BEOORDELING VAN GENEESMIDDELEN
Netherlands
EU contribution
€ 0
Address
Graadt Van Roggenweg 500
3531AH Utrecht
Activity type
Public bodies (excluding Research Organisations and Secondary or Higher Education Establishments)
PFIZER MANUFACTURING AUSTRIA GMBH

Participation ended

Austria
EU contribution
€ 0
Address
Uferstrasse 15
2304 Orth An Der Donau
Activity type
Private for-profit entities (excluding Higher or Secondary Education Establishments)