In the past decade, new approaches to the discovery and development of vaccines have transformed the field. Advances during the COVID‐19 pandemic allowed the production of billions of vaccine doses per year using novel platforms such as messenger RNA and viral vectors. Improvements in the analytical toolbox, equipment, and bioprocess technology have made it possible to achieve both unprecedented speed in vaccine development and scale of vaccine manufacturing. Macromolecular structure‐function characterization technologies, combined with improved modeling and data analysis, enable quantitative evaluation of vaccine formulations at single‐particle resolution and guided design of vaccine drug substances and drug products. These advances play a major role in precise assessment of critical quality attributes of vaccines delivered by newer platforms. Innovations in label‐free and immunoassay technologies aid in the characterization of antigenic sites and the development of robust in vitro potency assays. These methods, along with molecular techniques such as next‐generation sequencing, will accelerate characterization and release of vaccines delivered by all platforms. Process analytical technologies for real‐time monitoring and optimization of process steps enable the implementation of quality‐by‐design principles and faster release of vaccine products. In the next decade, the field of vaccine discovery and development will continue to advance, bringing together new technologies, methods, and platforms to improve human health.

中文翻译：

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疫苗工艺技术——十年的进步

在过去的十年中，发现和开发疫苗的新方法已经改变了这个领域。 COVID-19 大流行期间的进步允许使用信使 RNA 和病毒载体等新型平台每年生产数十亿剂疫苗。分析工具箱、设备和生物工艺技术的改进使得疫苗开发速度和疫苗生产规模达到前所未有的速度。大分子结构-功能表征技术与改进的建模和数据分析相结合，能够在单颗粒分辨率下定量评估疫苗配方，并指导疫苗原料药和药品的设计。这些进步在精确评估新平台提供的疫苗的关键质量属性方面发挥着重要作用。无标记和免疫测定技术的创新有助于抗原位点的表征和强大的体外效力测定的开发。这些方法与下一代测序等分子技术一起，将加速所有平台提供的疫苗的表征和发布。用于实时监控和优化工艺步骤的工艺分析技术能够实施质量源于设计的原则并加快疫苗产品的发布。未来十年，疫苗发现和开发领域将继续发展，汇集新技术、方法和平台来改善人类健康。