Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies

Marlies Halder; Hilde Depraetere; Frédérique Delannois; Arnoud Akkermans; Marie-Emmanuelle Behr-Gross; Martijn Bruysters; Jean-François Dierick; Carmen Jungbäck; Imke Kross; Bernard Metz; Jeroen Pennings; Peter Rigsby; Patrice Riou; Elisabeth Balks; Alexandre Dobly; Odile Leroy; Catrina Stirling

doi:10.1016/j.biologicals.2018.01.003

Recommendations of the VAC2VAC workshop on the design of multi-centre validation studies

Biologicals. 2018 Mar:52:78-82. doi: 10.1016/j.biologicals.2018.01.003. Epub 2018 Feb 1.

Authors

Marlies Halder¹, Hilde Depraetere², Frédérique Delannois³, Arnoud Akkermans⁴, Marie-Emmanuelle Behr-Gross⁵, Martijn Bruysters⁶, Jean-François Dierick⁷, Carmen Jungbäck⁸, Imke Kross⁹, Bernard Metz¹⁰, Jeroen Pennings¹¹, Peter Rigsby¹², Patrice Riou¹³, Elisabeth Balks¹⁴, Alexandre Dobly¹⁵, Odile Leroy¹⁶, Catrina Stirling¹⁷

Affiliations

¹ European Commission, DG Joint Research Centre, Ispra, Italy. Electronic address: marlies.halder@ec.europa.eu.
² European Vaccines Initiative, Heidelberg, Germany. Electronic address: hilde.depraetere@euvaccine.eu.
³ GSK, Rixensart, Belgium. Electronic address: frederique.x.delannois@gsk.com.
⁴ National Institute of Public Health and the Environment, Bilthoven, The Netherlands. Electronic address: arnoud.akkermans@rivm.nl.
⁵ Council of Europe, European Directorate for the Quality of Medicines & HealthCare, Strasbourg, France. Electronic address: marie-emmanuelle.behr-gross@edqm.eu.
⁶ National Institute of Public Health and the Environment, Bilthoven, The Netherlands. Electronic address: martijn.bruysters@rivm.nl.
⁷ GSK, Rixensart, Belgium. Electronic address: jean-francois.m.dierick@gsk.com.
⁸ IABS-EU, Lyon, France. Electronic address: carmen.jungbaeck@iabs.org.
⁹ Intervet International BV, Boxmeer, The Netherlands. Electronic address: imke.kross@merck.com.
¹⁰ Intravacc, Bilthoven, The Netherlands. Electronic address: bernard.metz@intravacc.nl.
¹¹ National Institute of Public Health and the Environment, Bilthoven, The Netherlands. Electronic address: jeroen.pennings@rivm.nl.
¹² National Institute for Biological Standards and Control, Potters Bar, UK. Electronic address: peter.rigsby@nibsc.org.
¹³ Sanofi Pasteur, Lyon, France. Electronic address: patrice.riou@sanofi.com.
¹⁴ Paul Ehrlich Institut, Langen, Germany. Electronic address: elisabeth.balks@pei.de.
¹⁵ Scientific Institute of Public Health, Brussels, Belgium. Electronic address: Alexandre.Dobly@wiv-isp.be.
¹⁶ European Vaccines Initiative, Heidelberg, Germany. Electronic address: odile.leroy@euvaccine.eu.
¹⁷ Zoetis, UK. Electronic address: catrina.stirling@zoetis.com.

Abstract

Within the Innovative Medicines Initiative 2 (IMI 2) project VAC2VAC (Vaccine batch to vaccine batch comparison by consistency testing), a workshop has been organised to discuss ways of improving the design of multi-centre validation studies and use the data generated for product-specific validation purposes. Moreover, aspects of validation within the consistency approach context were addressed. This report summarises the discussions and outlines the conclusions and recommendations agreed on by the workshop participants.

Keywords: 3R principles; Biological Standardisation Programme; Consistency approach; Implementation of non-animal methods; Regulatory acceptance; Vaccine quality control; Validation.

MeSH terms

Consensus Development Conferences as Topic*
Humans
Multicenter Studies as Topic*
Practice Guidelines as Topic*
Vaccines / therapeutic use*
Validation Studies as Topic*

Substances

Vaccines