重组治疗用生物技术产品临床试验申报阶段病毒安全控制的一般考量

General considerations for viral safety control of recombinant therapeutic biotechnological products during the CTA phase

病毒污染风险控制一直是重组生物技术产品安全性控制的重要组成部分。目前我国尚未针对重组治疗用生物技术产品出台临床试验申报阶段病毒安全控制技术指南,而上市阶段的技术指南来源较为繁复,在一定程度上给研究人员带来了困扰,延缓了新药的研发进程。因此,本文将从现行指导原则的技术要求、现行版《中华人民共和国药典》技术要求和审评实践3个方面,对重组治疗用生物技术产品在临床试验申报阶段病毒安全控制的基本技术要求进行讨论,以期能提高相关产品的研发质量,加速申报进程。

The risk control of viral contamination has always been an important part of the safety control of recombinant biotechnology products.At present,China has not issued technical guidelines for viral safety control in the clinical trial application stage for recombinant therapeutic biotech products,while the sources of technical guidelines in the marketing stage are complicated,which to some extent brings troubles to researchers and delays the development process of new drugs.Therefore,in order to improve the R&D quality of related products and accelerate the application process,this article will discuss the basic technical requirements for viral safety control of recombinant therapeutic biotechnology products in the clinical trial application phase from three aspects:the technical requirements of the current technical guidelines,the technical requirements of the Chinese Pharmacopoeia,and the review practice.