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<p>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-chromatography tandem mass spectrometry (LC/MS/MS) to support accelerated process development for recombinant protein vaccines. This suite of assays was deployed to support rapid, scientific decision-making enabling the transition from completion of a placebo-controlled dose-ranging Phase 2 study to the start of the global Phase 3 safety and efficacy trial in less than 2&#xa0;weeks.</p>

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Accelerated vaccine process development by orthogonal protein characterization

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年4月7日

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  • D. Andrew James,
  • Lisa Szymkowicz,
  • Lois Yin,
  • Hetvi Shah,
  • Michael Leach,
  • Roman M. Chicz

摘要

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-chromatography tandem mass spectrometry (LC/MS/MS) to support accelerated process development for recombinant protein vaccines. This suite of assays was deployed to support rapid, scientific decision-making enabling the transition from completion of a placebo-controlled dose-ranging Phase 2 study to the start of the global Phase 3 safety and efficacy trial in less than 2 weeks.