摘要
治疗性单克隆抗体制品在肿瘤、自身免疫、器官移植和感染性疾病的治疗中均取得了显著疗效,其品种和市场份额逐年显著提高。随着新的治疗性单克隆抗体制品的研发和上市,不同产品的质量控制研究,特别是新技术在质量控制中的应用被提到新的高度。由于治疗性单克隆抗体制品结构和生产的复杂性,使得质量控制的复杂程度也相应提高。本文结合治疗性单克隆抗体质量控制的工作经验和国际上的最新进展,对治疗性单克隆抗体质量控制项目设定、标准和方法进展进行论述。
The curative effects of therapeutic monoclonal antibody products have been proved for the treatment of cancer, autoimmune diseases, transplantation and infectious diseases. The varieties and market share of therapeutic monoclonal antibody products have risen considerably year after year. Along with the development and marketing of new therapeutic monoclonal antibodies, more importance has been attached to the quality control of these products so as to ensure their quality. Because of the complexity of therapeutic monoclonal antibody products both in their structure and manufacturing, the quality controls of the products become more difficult. This article briefly reviewed the principle of standard establishment and methods for the quality control of therapeutic monoclonal antibody products based on the latest progress in the world and our working experience in the quality control of the products.
出处
《中国执业药师》
CAS
2013年第1期25-30,36,共7页
China Licensed Pharmacist
基金
"重大新药创制"科技重大专项(2009ZX09307-001)
国家高技术研究发展计划(863计划)(2007AA021601
2007AA021204)
关键词
治疗性单克隆抗体
质量控制
方法
标准
Therapeutic Monoclonal Antibody
Quality Control
Method
Specification
