Quality assurance at the point-of-care: Noninvasively detecting vaccine freezing variability using water proton NMR.

Printer-friendly versionPrinter-friendly versionPDF versionPDF version
TitleQuality assurance at the point-of-care: Noninvasively detecting vaccine freezing variability using water proton NMR.
Publication TypeJournal Article
Year of Publication2020
AuthorsBriggs, KT, Taraban, MB, Y Yu, B
JournalVaccine
Volume38
Issue31
Pagination4853-4860
Date Published2020 Jun 26
ISSN1873-2518
Abstract

Aluminum-adjuvanted vaccines are freeze-sensitive products that require attentive cold chain adherence. Freeze/thaw events can be tested using "The World Health Organization Shake Test", a qualitative test whereby a vial from the batch suspected to have been frozen is checked to infer whether the whole batch has been frozen. In this paper, we present a noninvasive and quantitative method to detect whether a vial of liquid vaccine has experienced freeze/thaw using the water proton transverse relaxation rate by Nuclear Magnetic Resonance relaxometry (wNMR relaxometry). Importantly, wNMR relaxometry does not compromise the vial's integrity so the analyzed vial can be used for vaccination if it meets the quality specifications. Vial-to-vial variability in freezing susceptibility within a single carton of vaccine vials was also detected, both by visual observation and concurrently by wNMR relaxometry. This variability brings into question the practice of using one or a few vials in a batch of vaccines to infer about the quality of the whole batch.

DOI10.1016/j.vaccine.2020.05.049
Alternate JournalVaccine
PubMed ID32482461