摘要
随着科学研究成果的不断转化应用,新兴治疗产品的种类越来越多。由于新兴治疗产品在生产工艺方面与传统重组蛋白质或抗体类产品存在较大差异,因此外源因子风险控制的侧重点也往往有所不同。部分新兴治疗产品在工艺步骤中缺乏除菌过滤和/或病毒灭活/去除工艺步骤,因而采用在生产工艺中的多个环节联合控制外源因子污染的风险尤为重要。外源因子的风险控制与产品质量和安全性密切相关,在产品研发和技术审评中应得到足够的重视。本文结合实际审评过程中的经验,对当前新兴治疗产品研发过程中,尤其是临床试验申请阶段,外源因子控制方面存在的缺陷进行总结和分析,希望能对后续新兴治疗产品的研发和审评提供参考,加快推进我国新兴治疗产品的临床转化应用。
With the continuous transformation and application of scientific research results,there are increasing types of advanced therapeutic products.As the production process of advanced therapeutic products is quite different from traditional recombinant protein or antibody products,the focus of risk control of adventitious agents are often not the same.Some advanced therapeutic products lack sterilization filtration and/or virus clearance/removal process steps in the process,thus the control of contamination risk for adventitious agents of raw materials is particularly important.The risk control of adventitious agents is closely related to product quality and safety,which should be given sufficient attention in product development and technical assessment.Based on the experience in the actual review process,this article summarizes and analyzes the deficiencies in the control of adventitious agents in the development of the advanced therapeutic product,especially at the IND stage,hoping to provide reference for the subsequent development and assessment of advanced therapeutic products,and accelerate the clinical transformation and application of advanced therapeutic products in our country.
作者
徐隆昌
崔靖
韦薇
XU Long-chang;CUI Jing;WEI Wei(Center for Drug Evaluation,National Medical Products Administration,Beijing 100022,China)
出处
《中国新药杂志》
CAS
CSCD
北大核心
2022年第11期1052-1056,共5页
Chinese Journal of New Drugs
关键词
新兴治疗产品
外源因子
审评
风险控制
advanced therapeutic products
adventitious agents
assessment
risk control
