Formulation Development of a COVID-19 Recombinant Spike Protein-Based Vaccine.
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ABSTRACT: The purpose of this study was to develop a formulation for a recombinant prefusion spike protein vaccine against SARS-CoV-2. It was found that the spike protein was susceptible to aggregation due to mechanical stress. Therefore, formulation studies were initiated focused on screening pharmaceutical excipients capable of preventing this. The screening of a panel of potential stabilizing conditions found that Tween 20 could inhibit mechanically induced aggregation. A concentration-dependent study indicated that a higher concentration of Tween 20 (0.2% v/v) was required to prevent conformational changes in the trimer. The conformational changes induced by mechanical stress were characterized by size exclusion chromatography (SEC) and hydrogen-deuterium exchange mass spectrometry
SUBMITTER: Xiao E
PROVIDER: S-EPMC11360652 | biostudies-literature | 2024 Jul
REPOSITORIES: biostudies-literature
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