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VAC2VAC

Financiado

Cerrado

Vaccine lot to Vaccine lot comparison by consistency testing.

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. Cur... ver más

28/02/2022

EUROPEAN VACCINE I...

16M€

Presupuesto del proyecto: 16M€

Líder del proyecto

EUROPEAN VACCINE INITIATIVE E.V No se ha especificado una descripción o un objeto social para esta compañía.

Fecha límite participación Sin fecha límite de participación.

Ver 24 Participantes

Financiación concedida El organismo H2020 notifico la concesión del proyecto el día 2022-02-28

IMI2-2015-03-04: The Consistency Approach to Quality...

I+D

Cerrada hace 9 años

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Información adicional privada

No hay información privada compartida para este proyecto. Habla con el coordinador.

24 Participantes

EUROPEAN VACCINE INITIATIVE...

1.06M€ | Lider

STEREOCARTO S.L.

561.95K€ | Participante

AGENTSCHAP COLLEGE TER BEOOR...

312.50K€ | Participante

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Duración del proyecto: 70 meses Fecha Inicio: 2016-04-14
Fecha Fin: 2022-02-28

Líder del proyecto

EUROPEAN VACCINE INITIATIVE E.V No se ha especificado una descripción o un objeto social para esta compañía.

Presupuesto del proyecto 16M€

Fecha límite de participación Sin fecha límite de participación.

Descripción del proyecto 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

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