Drivers and barriers in the consistency approach for vaccine batch release testing: Report of an international workshop

Martijn W P Bruysters; Marie-Jeanne Schiffelers; Marieke Hoonakker; Carmen Jungbaeck; Ian Ragan; Eddy Rommel; Ton van der Stappen; Laura Viviani; Ellen V Hessel; Arnoud M Akkermans; Rob J Vandebriel

doi:10.1016/j.biologicals.2017.06.006

Drivers and barriers in the consistency approach for vaccine batch release testing: Report of an international workshop

Biologicals. 2017 Jul:48:1-5. doi: 10.1016/j.biologicals.2017.06.006. Epub 2017 Jun 27.

Authors

Affiliations

¹ National Institute of Public Health and the Environment, P.O. Box 1, 3720 BA Bilthoven, The Netherlands. Electronic address: [email protected].
² Utrecht University School of Governance (USBO), Bijlhouwerstraat 6, 3511 ZC Utrecht, The Netherlands. Electronic address: [email protected].
³ Institute for Translational Vaccinology (Intravacc), Bilthoven, The Netherlands. Electronic address: [email protected].
⁴ Paul-Ehrlich-Institut, Paul-Ehrlich-Straße 51-59, D-63225 Langen, Germany. Electronic address: [email protected].
⁵ NC3Rs Board, Gibbs Building, 215 Euston Road, London NW1 2BE, UK. Electronic address: [email protected].
⁶ Rommel Consulting Partners, B-1370 Jodoigne, Belgium. Electronic address: [email protected].
⁷ Medicines Evaluation Board (CBG-MEB), Utrecht, The Netherlands. Electronic address: [email protected].
⁸ Independent Consultant, Switzerland. Electronic address: [email protected].
⁹ National Institute of Public Health and the Environment, P.O. Box 1, 3720 BA Bilthoven, The Netherlands. Electronic address: [email protected].
¹⁰ National Institute of Public Health and the Environment, P.O. Box 1, 3720 BA Bilthoven, The Netherlands. Electronic address: [email protected].
¹¹ National Institute of Public Health and the Environment, P.O. Box 1, 3720 BA Bilthoven, The Netherlands. Electronic address: [email protected].

PMID: 28666717
DOI: 10.1016/j.biologicals.2017.06.006

Abstract

Safety and potency assessment for batch release testing of established vaccines still relies partly on animal tests. An important avenue to move to batch release without animal testing is the consistency approach. This approach is based on thorough characterization of the vaccine, and the principle that the quality of subsequent batches is the consequence of the application of consistent production of batches monitored by a GMP quality system. Efforts to implement the consistency approach are supported by several drivers from industry, government, and research, but there are also several barriers that must be overcome. A workshop entitled "Consistency Approach, Drivers and Barriers" was organized, which aimed to discuss and identify drivers and barriers for the implementation of the 3Rs in the consistency approach from three different perspectives/domains (industry, regulatory and science frameworks). The workshop contributed to a better understanding of these drivers and barriers and resulted in recommendations to improve the overall regulatory processes for the consistency approach. With this report, we summarise the outcome of this workshop and intend to offer a constructive contribution to the international discussion on regulatory acceptance of the consistency approach.

Keywords: 3R; Barriers; Consistency approach; Drivers; Regulatory acceptance; Vaccine batch release.

MeSH terms

Congresses as Topic
Drug Industry* / legislation & jurisprudence
Drug Industry* / standards
Humans
Quality Control*
Vaccines / standards*

Substances

Vaccines