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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 biotherapeutics are currently the fastest growing biopharmaceuticals in the world. The normative production and quality control of pharmaceuticals are closely related to their safety and effectiveness. The general requirements for the quality control of such pharmaceuticals are provided in the European and American pharmacopoeias. The 2015 edition of the “Chinese Pharmacopoeia” is under the guiding ideology of preparation for further safeguarding drug safety and improving quality control , Also intends to include the overall requirements of the monoclonal antibody biological treatment of drugs, related drafting work from the product scope, manufacturing and product verification and other aspects described.