| 郭莎,贾哲,吴昊,王兰.单克隆抗体颗粒表征的现状与挑战[J].中国药事,2022,36(2):161-169 |
| 单克隆抗体颗粒表征的现状与挑战 |
| Current Status and Challenges of Particle Characterization in Monoclonal Antibody Formulation |
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| DOI：10.16153/j.1002-7777.2022.02.008 |
| 中文关键词: 单克隆抗体 颗粒 亚可见颗粒 颗粒计数 颗粒表征 安全性 |
| 英文关键词: monoclonal antibody particle sub-visible particle particle quantification particle characterization safety |
| 基金项目:2020年国家药品标准提高项目课题—眼用注射剂的不溶性微粒检测(编号 2020S11) |
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| 中文摘要: |
| 随着生物技术的快速发展，治疗性单克隆抗体已成为生物技术药物中增长最快速的部分，也成为临床医疗的重要组成部分，并不断为患者提供创新的治疗选择。单克隆抗体中的颗粒物是影响药物安全性和有效性的重要因素。本文论述了近年来单克隆抗体药物药典监测要求、重要的检测技术及各自应用范围、在药物研发不同阶段的监测考虑及对颗粒进行全面表征与重点表征中存在的挑战，探讨了微粒控制的发展趋势、存在的难点及在药物安全性监测中可能的应用前景。 |
| 英文摘要: |
| With the rapid development of biotechnology, therapeutic monoclonal antibodies have become the fastest growing part of biotechnology drugs, and have become an important part in clinical therapeutics, and constantly provide innovative treatment options for patients. Particulate matter in monoclonal antibody formulations is an important factor affecting safety, and constantly efficacy of drugs. Pharmacopoeia monitoring requirements of monoclonal antibody drugs, the important testing techniques and their respective application scope in biopharmaceuticals, the monitoring considerations at different stages of drug development and the challenges existing in the comprehensive characterization and key characterization of particles in recent years were discussed. The development trend, existing difficulties and possible application prospect in drug safety monitoring of particle control were also discussed. |
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