In Vitro Potency Assay for Hepatitis A Vaccines: Development of a Unique Economical Test

Poirier, Bertrand; Morgeaux, Sylvie; Variot, P; Fuchs, Florence

doi:10.1006/biol.2001.0264

Cited by 4 publications

(1 citation statement)

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“…These antigen quantification methods may be physiochemical or immunochemical assays that are specific for one or more dominant antigens of the vaccines. In particular, the development of enzyme-linked immunosorbent assays (ELISAs) for antigen quantification has been successful for the replacement of in vivo potency tests of several vaccines in Europe, including those against Newcastle disease in poultry, foot-and-mouth disease in cattle, leptospirosis in cattle and dogs (monographs 0447 and 1939), rabies in both animals and humans, and hepatitis A and B in humans (Figure 1a) [17,20,[26][27][28][29]. Other ELISAs for antigen quantification have shown to be successful in determining the potency of some but not all inactivated vaccines and toxoid vaccines, but these are not yet fully validated and/or approved by the regulatory authorities in Europe.…”

Section: Article Highlightsmentioning

confidence: 99%

Overcoming scientific barriers in the transition fromin vivoto non-animal batch testing of human and veterinary vaccines

Biggelaar

Hoefnagel

Vandebriel

et al. 2021

Expert Review of Vaccines

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Introduction: Before release, vaccine batches are assessed for quality to evaluate whether they meet the product specifications. Vaccine batch tests, in particular of inactivated and toxoid vaccines, still largely rely on in vivo methods. Improved vaccine production processes, ethical concerns, and suboptimal performance of some in vivo tests have led to the development of in vitro alternatives.Areas covered: This review describes the scientific constraints that need to be overcome for replacement of in vivo batch tests, as well as potential solutions. Topics include the critical quality attributes of vaccines that require testing, the use of cell-based assays to mimic aspects of in vivo vaccine-induced immune responses, how difficulties with testing adjuvanted vaccines in vitro can be overcome, the use of altered batches to validate new in vitro test methods, and how cooperation between different stakeholders is key to moving the transition forward. Expert opinion: For safety testing, many in vitro alternatives are already available or at an advanced level of development. For potency testing, in vitro alternatives largely comprise immunochemical methods that assess several, but not all critical vaccine properties. One-to-one replacement by in vitro alternatives is not always possible and a combination of methods may be required.

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Section: Article Highlightsmentioning

confidence: 99%