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Functional profiling of Covid 19 vaccine candidate by flow virometry.
Prout, Ashley; Rustandi, Richard R; Tubbs, Christopher; Winters, Michael A; McKenna, Philip; Vlasak, Josef.
  • Prout A; Vaccine Analytical Research and Development, Merck & Co., Inc., West Point, PA, USA.
  • Rustandi RR; Vaccine Analytical Research and Development, Merck & Co., Inc., West Point, PA, USA.
  • Tubbs C; Vaccine Analytical Research and Development, Merck & Co., Inc., West Point, PA, USA.
  • Winters MA; Vaccine Process Research and Development, Merck & Co., Inc., West Point, PA, USA.
  • McKenna P; Infectious Diseases-Vaccines, Merck & Co., Inc., West Point, PA, USA.
  • Vlasak J; Vaccine Analytical Research and Development, Merck & Co., Inc., West Point, PA, USA. Electronic address: josef_vlasak@merck.com.
Vaccine ; 40(37): 5529-5536, 2022 09 02.
Article in English | MEDLINE | ID: covidwho-1977891
ABSTRACT
Vaccine development is a complex process, starting with selection of a promising immunogen in the discovery phase, followed by process development in the preclinical phase, and later by clinical trials in tandem with process improvements and scale up. A large suite of analytical techniques is required to gain understanding of the vaccine candidate so that a relevant immunogen is selected and subsequently manufactured consistently throughout the lifespan of the product. For viral vaccines, successful immunogen production is contingent on its maintained antigenicity and/or infectivity, as well as the ability to characterize these qualities within the context of the process, formulation, and clinical performance. In this report we show the utility of flow virometry during preclinical development of a Covid 19 vaccine candidate based on SARS-CoV-2 spike (S) protein expressed on vesicular stomatitis virus (VSV). Using a panel of monoclonal antibodies, we were able to detect the S protein on the surface of the recombinant VSV virus, monitor the expression levels, detect differences in the antigen based on S protein sequence and after virus inactivation, and monitor S protein stability. Collectively, flow virometry provided important data that helped to guide preclinical development of this vaccine candidate.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: Vaccine Year: 2022 Document Type: Article Affiliation country: J.vaccine.2022.08.006

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Vaccines / COVID-19 Type of study: Prognostic study Topics: Vaccines Limits: Humans Language: English Journal: Vaccine Year: 2022 Document Type: Article Affiliation country: J.vaccine.2022.08.006