Accelerated vaccine process development by orthogonal protein characterization.

IF 3.9 2区综合性期刊 Q1 MULTIDISCIPLINARY SCIENCES

Scientific Reports Pub Date : 2025-04-07 DOI:10.1038/s41598-025-96642-y

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

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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-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.

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通过正交蛋白表征加速疫苗工艺开发。

COVID-19大流行改变了疫苗开发模式，从概念到临床安全性和有效性的时间表加快了。在类似的时间限制下，疫苗项目的特性和释放分析也被开发出来，以支持生物工艺开发、规模扩大和配方制定。在这些疫苗的开发过程中，出现了关注的SARS-CoV-2变体（VOCs），需要将其他抗原整合到目标产品谱中。支持添加新抗原变体（身份、数量、抗原性/效力）的生化测试需要大量的重新开发。在这里，我们提出了一种反相高效液相色谱法，通过简单Wes和液相色谱串联质谱（LC/MS/MS）的正交鉴定表征来检测抗原纯度，以支持重组蛋白疫苗的加速工艺开发。该检测套件用于支持快速、科学的决策，从而在不到2周的时间内完成从安慰剂对照剂量范围2期研究到开始全球3期安全性和有效性试验的过渡。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Scientific Reports Natural Science Disciplines-

CiteScore

7.50

自引率

4.30%

发文量

19567

审稿时长

3.9 months

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