抗体药物制剂处方中的可见异物/不溶性微粒  

The visible particles or insoluble particles in antibody drug formulations

作　　者：贾东晨 何伍 JIA Dong-chen;HE Wu(Center for Drug Evaluation,National Medical Products Administration,Beijing,000229 China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100122

出　　处：《中国新药杂志》2022年第10期933-936,共4页Chinese Journal of New Drugs

摘　　要：聚山梨酯20/聚山梨酯80及泊洛沙姆188是抗体药物制剂处方中常用的稳定剂。随着研究及检测技术的不断进步,抗体药物在放置过程中,蛋白来源的可见异物/不溶性微粒可被检测到呈增加趋势,其起因可能与抗体药物制剂处方有关。本文对由制剂处方中聚山梨酯20/聚山梨酯80、泊洛沙姆引起的可见异物/不溶性微粒进行原因分析,明确现行指导原则及法规对可见异物/不溶性微粒的要求。在此基础上,结合药学审评实践,浅谈对抗体药物制剂处方中的可见异物/不溶性微粒审评的基本考量,以期提高企业对此类问题的关注,并为同类产品的研发提供参考。Polysorbate 20, polysorbate 80, and poloxamer 188 are commonly used surfactants in antibody drug formulations. With the advances in related research and detection technology, an increasing trend of visible particles or insoluble particles originating from proteins have been detected during the storage period of antibody drugs, probably due to their formulations. The potential causes of polysorbate 20, polysorbate 80, and poloxamer 188 in formulations leading to visible particles or insoluble particles were analyzed in this article, and the requirements in current guidelines and regulations for these particles were clarified. On this basis, combined with pharmaceutical review practices, basic considerations of visible particles or insoluble particles in antibody drug formulations were briefly discussed in order to raise attention to this kind of issues by industry and also provide references for the R&D of products in the same category.

关 键 词：可见异物/不溶性微粒 聚山梨酯 泊洛沙姆188 药学评价 

分 类 号：R94[医药卫生—药剂学]