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Towards ambient temperature-stable vaccines: the identification of thermally stabilizing liquid formulations for measles virus using an innovative high-throughput infectivity assay.

Abstract
As a result of thermal instability, some live attenuated viral (LAV) vaccines lose substantial potency from the time of manufacture to the point of administration. Developing regions lacking extensive, reliable refrigeration ("cold-chain") infrastructure are particularly vulnerable to vaccine failure, which in turn increases the burden of disease. Development of a robust, infectivity-based high throughput screening process for identifying thermostable vaccine formulations offers significant promise for vaccine development across a wide variety of LAV products. Here we describe a system that incorporates thermal stability screening into formulation design using heat labile measles virus as a prototype. The screening of >11,000 unique formulations resulted in the identification of liquid formulations with marked improvement over those used in commercial monovalent measles vaccines, with <1.0 log loss of activity after incubation for 8h at 40°C. The approach was shown to be transferable to a second unrelated virus, and therefore offers significant promise towards the optimization of formulation for LAV vaccine products.
AuthorsLisa D Schlehuber, Iain J McFadyen, Yu Shu, James Carignan, W Paul Duprex, William R Forsyth, Jason H Ho, Christine M Kitsos, George Y Lee, Douglas A Levinson, Sarah C Lucier, Christopher B Moore, Niem T Nguyen, Josephine Ramos, B André Weinstock, Junhong Zhang, Julie A Monagle, Colin R Gardner, Juan C Alvarez
JournalVaccine (Vaccine) Vol. 29 Issue 31 Pg. 5031-9 (Jul 12 2011) ISSN: 1873-2518 [Electronic] Netherlands
PMID21616113 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)
CopyrightCopyright © 2011 Elsevier Ltd. All rights reserved.
Chemical References
  • Excipients
  • Measles Vaccine
Topics
  • Chemistry, Pharmaceutical (methods)
  • Drug Stability
  • Excipients (chemistry)
  • High-Throughput Screening Assays (methods)
  • Humans
  • Measles Vaccine (chemistry)
  • Measles virus (drug effects, pathogenicity, radiation effects)
  • Temperature

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