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

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    Authors
    Bruysters, Martijn W P
    Schiffelers, Marie-Jeanne
    Hoonakker, Marieke
    Jungbaeck, Carmen
    Ragan, Ian
    Rommel, Eddy
    van der Stappen, Ton
    Viviani, Laura
    Hessel, Ellen V
    Akkermans, Arnoud M
    Vandebriel, Rob J
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    Type
    Article
    Language
    en
    
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    Title
    Drivers and barriers in the consistency approach for vaccine batch release testing: Report of an international workshop.
    Published in
    Biologicals 2017, 48:1-5
    Publiekssamenvatting
    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.
    DOI
    10.1016/j.biologicals.2017.06.006
    PMID
    28666717
    URI
    http://hdl.handle.net/10029/620981
    ae974a485f413a2113503eed53cd6c53
    10.1016/j.biologicals.2017.06.006
    Scopus Count
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