Accelerated vaccine process development by orthogonal protein characterization.

ABSTRACT: The COVID-19 pandemic altered the vaccine development paradigm with accelerated timelines from concept through clinical safety and efficacy. Characterization and release assays for vaccine programs were developed under similar time constraints to support bioprocess development, scaleup and formulation. During the development of these vaccines, SARS-CoV-2 variants of concern (VOCs) emerged requiring integration of additional antigens into the target product profile. Biochemical testing to support the addition of new antigen variants (identity, quantity, antigenicity/potency) needed substantial re-development. Here we present a reversed-phase high-performance liquid-chromatography method for antigen purity with orthogonal identification characterization comprising of Simple Wes and liquid-ch

SUBMITTER: James DA 

PROVIDER: S-EPMC11976966 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature