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*

*Corresponding author for this work

Research output: Contribution to journalArticleAcademicpeer-review

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.

Original languageEnglish
Pages (from-to)1-5
Number of pages5
JournalBiologicals
Volume48
DOIs
Publication statusPublished - Jul 2017

Keywords

  • 3R
  • Barriers
  • Consistency approach
  • Drivers
  • Regulatory acceptance
  • Vaccine batch release

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