新形势下生物制品病毒清除的挑战和思考  

Challenges and reflections on viral clearance of biological products in the new situation

作　　者：张乐 温凤鲜 周沙沙 官艳东 徐明明 

机构地区：[1]北京义翘神州科技股份有限公司,100023

出　　处：《中国医药生物技术》2025年第2期174-180,共7页Chinese Medicinal Biotechnology

摘　　要：生物制药行业飞速发展,出现了很多新技术和新产品,其对病毒安全性评价提出了挑战。为探讨新形势下生物制品病毒安全性控制策略与病毒清除验证实施方式,本文根据生物制品病毒安全性指导原则的变化,从病毒载体类产品、连续制造工艺、先验知识和(或)平台验证三方面,比较了病毒载体类产品和传统重组产品、连续制造工艺和传统批生产的病毒安全性控制策略以及先验知识和(或)平台验证的应用策略和传统病毒清除工艺验证策略的异同,对新形势下生物制品病毒安全性控制策略与病毒清除验证实施方式给出建议,可为研究者、生产企业和监管机构提供一定借鉴。The rapid development of the biopharmaceutical industry has led to the introduction of numerous new technologies and products,posing challenges to the assessment of their viral safety.To address the viral safety control strategy and validation of viral clearance for biologics in this new situation,this paper reviews studies on viral vector-based products,continuous manufacturing process and the utilization of prior knowledge and platform validation in accordance with the updated viral safety guideline for biologics.It compares the viral safety control strategies of viral vector-based products with traditional recombinant products,as well as the differences between continuous manufacturing processes and traditional batch production.Furthermore,it discusses the application of prior knowledge and platform validation strategy versus the traditional viral clearance validation strategy.Recommendations are made for viral safety control strategies and the implementation of virus clearance validation in the new environment,offering guidance for researchers,manufacturing companies,and regulatory bodies.

关 键 词：生物制品 病毒安全性 病毒清除 病毒载体 连续制造 先验知识 

分 类 号：R95[医药卫生—药学]