关于我国药典单克隆抗体类生物治疗药物总论的思考

Points to Consider for the General Monograph of Monoclonal Antibody Based Biotherapeutics in Chinese Pharamacopeia

单克隆抗体类生物治疗药物目前是国内外生物药中增长最快的领域。药品的规范生产与质量控制与其安全有效性息息相关,欧美药典中均设有对此类药品质量控制的总体要求,2015版《中国药典》在进一步保障药品安全和提高质量控制水平的编制指导思想下,也拟纳入对单克隆抗体类生物治疗药物的总体要求,就相关起草工作从产品涉及范畴、制造与产品检定等方面进行阐述。

Monoclonal antibody based biotherapeutics reflect the rapid progress achieved in global biopharmaceuticals area. Good manufacture practice and quality control are key contributions to the safety and efficacy of these drugs. General requirements for the control of monoclonal antibodies are embodied in European and United States Pharmacopeia. Chinese Pharmacopeia intend to draft and include general monograph of monoclonal antibody based biotherapeutics in the coming new edition, under the directions to further improve drug safety as well as to upgrade the technology level of quality control. This paper is to pave the way for the drafting of monograph of monoclonal antibody based biotherapeutics from the aspects including scope, manufacture and release control etc.