生物制药
药物开发
体内
抗体-药物偶联物
抗体
食品药品监督管理局
医学物理学
生化工程
药品
计算机科学
纳米技术
计算生物学
药理学
医学
单克隆抗体
生物
工程类
免疫学
材料科学
生物技术
作者
Tong Liu,Yiran Tao,Xuhan Xia,Ya Zhang,Ruijie Deng,Yuxi Wang
标识
DOI:10.1016/j.trac.2022.116621
摘要
Over the last decade, the biopharmaceutical market has witnessed a new wave of development in antibody–drug conjugates (ADCs) due to their high efficacy in cancer treatment. To date, thirteen U.S. Food and Drug Administration approved ADCs are available for clinical use. ADC development is dependent on analytical tools for comprehensively characterizing ADCs, from their biochemical attributes (such as drug-to-antibody ratio and conjugation sites) to their in vivo dynamics. This review will provide a general overview of ADC characterization from in vitro tests to in vivo dynamics. Recent advances in analytical techniques are helping us to better understand and optimize the quality, safety, and efficacy of ADCs. The advantages and limitations of these approaches will be described, and the challenges and potential opportunities for future ADC characterization will be discussed. The review will provide insights for the development of ADC analytical approaches, in turn facilitating the development of ADC drugs.
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