Analytical development for rapid response vaccines: start early, think ahead

Särnefält, Anna; Kromann, Ingrid

doi:10.18609/vac.2022.001

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Background and Current Challenge1

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2023

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“…However, these are rarely available for novel pathogens and innovative vaccine platforms, as shown during the COVID-19 pandemic. Early establishment of reagents and standards for these assays is an important factor in evaluating the vaccine performance at various stages 6 .…”

Section: Background and Current Challengementioning

confidence: 99%

Availability and use of Standards in vaccine development

Avumegah,

Mattiuzzo,

Särnefält

et al. 2023

npj Vaccines

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Reference materials are critical in assay development for calibrating and assessing their suitability. The devasting nature of the COVID-19 pandemic and subsequent proliferation of vaccine platforms and technologies has meant that there is even a greater need for standards for immunoassay development, which are critical to assess and compare vaccines’ responses. Equally important are the standards needed to control the vaccine manufacturing processes. Standardized vaccine characterization assays throughout process development are essential for a successful Chemistry, Manufacturing and Controls (CMC) strategy. In this perspective paper, we advocate for reference material incorporation into assays and their calibration to International Standards from preclinical vaccine development through control testing and provide insight into why this is necessary. We also provide information on the availability of WHO international antibody standards for CEPI-priority pathogens.

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Section: Background and Current Challengementioning

confidence: 99%