International AIDS Vaccine Initiative (IAVI), New York, New York.
Independent CMC Consultant, Paramus, New Jersey.
Mass Spectrom Rev. 2020 Mar;39(1-2):83-104. doi: 10.1002/mas.21571. Epub 2018 May 31.
Biological mass spectrometry has evolved as a core analytical technology in the last decade mainly because of its unparalleled ability to perform qualitative as well as quantitative profiling of enormously complex biological samples with high mass accuracy, sensitivity, selectivity and specificity. Mass spectrometry-based techniques are also routinely used to assess glycosylation and other post-translational modifications, disulfide bond linkage, and scrambling as well as for the detection of host cell protein contaminants in the field of biopharmaceuticals. The role of mass spectrometry in vaccine development has been very limited but is now expanding as the landscape of global vaccine development is shifting towards the development of recombinant vaccines. In this review, the role of mass spectrometry in vaccine development is presented, some of the ongoing efforts to develop vaccines for diseases with global unmet medical need are discussed and the regulatory challenges of implementing mass spectrometry techniques in a quality control laboratory setting are highlighted.
生物质谱在过去十年中已经发展成为核心分析技术，主要是因为它具有无与伦比的能力，可以对极其复杂的生物样品进行定性和定量分析，具有高质量精度、灵敏度、选择性和特异性。基于质谱的技术也常用于评估糖基化和其他翻译后修饰、二硫键连接以及重排，以及用于检测生物制药领域的宿主细胞蛋白污染物。质谱在疫苗开发中的作用非常有限，但随着全球疫苗开发的格局转向重组疫苗的开发，其作用正在扩大。在这篇综述中，介绍了质谱在疫苗开发中的作用，讨论了为具有全球未满足医疗需求的疾病开发疫苗的一些正在进行的努力，并强调了在质量控制实验室环境中实施质谱技术的监管挑战。
