我国生物制品分段生产可行性建议——基于苏州工业园区生物医药产业的探索  

Feasibility Study of Divided Manufacturing of Biological Products in China and Relevant Suggestions——A Case Study of the Biopharmaceutical Industry in Suzhou Industrial Park

作　　者：顾瑶华 操桂兰 董锐 卢渊 GU Yao-hua;CAO Gui-lan;DONG Rui;LU Yuan(Medical Products Management Center,Suzhou Industrial Park;Suzhou Industrial Park Administrative Committee)

机构地区：[1]苏州工业园区药品管理中心 [2]苏州工业园区管理委员会

出　　处：《中国食品药品监管》2021年第12期112-117,共6页China Food & Drug Administration Magazine

摘　　要：目前,随着生物医药产业的快速发展,以抗体药为代表的生物制品陆续上市,极大地满足了临床需求。国家也制定了一系列积极措施促进生物医药产业发展,但生物制品在生产中仍然面临一些亟待解决的问题。本文以生物制品分段生产为研究主体,选取生物医药发展较为成熟的苏州工业园区为研究样本,通过文献研究、实地调研等方式,探索我国生物制品分段生产实施的可行性,提出分段生产实施的路径框架,为解决当前我国生物医药产业的困境提供思路和参考。At present,with the rapid development of the biopharmaceutical industry,a number of biological products,including antibody drugs,have been approved for marketing,meeting patients’ clinical needs.China has formulated a series of supportive measures to promote the biopharmaceutical industry.However,the production of biological products still faces some problems that need to be addressed urgently.This article focuses on divided manufacturing of biological products and conducts a case study on the Suzhou Industrial Park,where the biopharmaceutical industry is relatively mature.Through literature review and field survey,the authors explore the feasibility of implementing divided manufacturing of biological products in China and propose a framework for its implementation,hoping to provide ideas for addressing current challenges facing the biopharmaceutical industry in China.

关 键 词：生物制品 分段生产 生物医药产业 可行性研究 

分 类 号：R95[医药卫生—药学]