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

Authors
  • Briggs, Katharine T1
  • Taraban, Marc B1
  • Yu, Y Bruce2
  • 1 Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore and the Institute for Bioscience and Biotechnology Research (IBBR), Rockville, MD 20850, USA.
  • 2 Department of Pharmaceutical Sciences, School of Pharmacy, University of Maryland, Baltimore and the Institute for Bioscience and Biotechnology Research (IBBR), Rockville, MD 20850, USA. Electronic address: [email protected]
Type
Published Article
Journal
Vaccine
Publication Date
Jun 26, 2020
Volume
38
Issue
31
Pages
4853–4860
Identifiers
DOI: 10.1016/j.vaccine.2020.05.049
PMID: 32482461
Source
Medline
Keywords
Language
English
License
Unknown

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. Copyright © 2020 Elsevier Ltd. All rights reserved.

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