化学
生物仿制药
背景(考古学)
质谱法
生物制药
表征(材料科学)
生化工程
序列(生物学)
纳米技术
色谱法
工程类
医学
古生物学
生物化学
遗传学
材料科学
内科学
生物
作者
Jérôme Castel,S. Delaux,Oscar Hernandez‐Alba,Sarah Cianférani
标识
DOI:10.1016/j.jpba.2023.115696
摘要
Biotherapeutics and their biosimilar versions have been flourishing in the biopharmaceutical market for several years. Structural and functional characterization is needed to achieve analytical biosimilarity through the assessment of critical quality attributes as required by regulatory authorities. The role of analytical strategies, particularly mass spectrometry-based methods, is pivotal to gathering valuable information for the in-depth characterization of biotherapeutics and biosimilarity assessment. Structural mass spectrometry methods (native MS, HDX-MS, top-down MS, etc.) provide information ranging from primary sequence assessment to higher order structure evaluation. This review focuses on recent developments and applications in structural mass spectrometry for biotherapeutic and biosimilar characterization.
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