生物制造
生物过程
聚糖
过程分析技术
设计质量
糖基化
关键质量属性
单克隆抗体
计算生物学
生物制药
毛细管电泳
生化工程
计算机科学
化学
生物技术
生物
色谱法
生物化学
工程类
抗体
免疫学
古生物学
物理化学
粒径
糖蛋白
作者
Erin K. Tiwold,Aron Gyorgypal,Shishir P. S. Chundawat
标识
DOI:10.1016/j.xphs.2023.01.012
摘要
N-glycosylation is a post-translational modification that occurs during the production of monoclonal antibody (mAb) therapeutics. During production of mAb based therapeutics the use of various hosts and cell culture additives attribute to glycan heterogeneity. The safety and efficacy of monoclonal antibodies with mechanism of actions that utilize Fc effector functions can be negatively impacted by glycan heterogeneity and thus is often considered a critical quality attribute (CQA). In this mini review, we discuss recent advances in mAb sample preparation specifically focused on denaturation, enzymatic processing, and released glycans derivatization methods. Additionally, we review the recent advances in characterization of released and intact N-glycans using chromatography, capillary electrophoresis, and mass spectrometry techniques with a focus on rapid, automated approaches that support analysis of glycosylation profiles of biopharmaceuticals. We delve into advances within sample preparation techniques that allow for rapid and robust sample preparation as well as how these techniques are being used for innovative at-line high-throughput screening and process analytical technology (PAT). The future of biomanufacturing is focused on decreasing process costs while increasing process understanding and quality for novel biologic candidates and biosimilars. Therefore, advances in PAT for biotherapeutics will positively influence current manufacturing practices and enable further bioprocess automation.
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