病毒清除工艺平台验证技术应用案例解析  

Case study on the application of validation technology in viral clearance process platform

作　　者：陈昊 何伍 CHEN Hao;HE Wu(Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国新药杂志》2025年第6期602-607,共6页Chinese Journal of New Drugs

摘　　要：病毒清除验证是生物制品病毒安全性的重要保障之一。目前,在临床试验阶段或申报上市阶段采用工艺平台作为病毒清除能力的验证策略已被ICH Q5A(R2)接受。病毒清除工艺平台验证技术,可以允许开发者在基于科学与风险的前提下适当减少临床前药物在病毒清除方面的验证研究,为申请人提供开发和申报过程中的时间和成本优势。但与此同时,如何建立和应用工艺平台,对申请人的工艺理解和生产经验提出了更高的要求和挑战。本文将围绕病毒清除工艺平台的前期风险评估、建立方法、应用等关键阶段,结合相应的案例分析,以期为该技术的开发和评价提供引导和实用参考。Virus clearance validation is a critical safeguard for ensuring the viral safety of biological products.Currently,the use of platform verification strategies for evaluating virus clearance capabilities during the clinical trial phase or new drug application has been accepted by ICH Q5A(R2).Platform validation technology allows developers to appropriately reduce the preclinical validation studies related to virus clearance,based on scientific and risk-based approaches,thus providing applicants with significant time and cost advantages during the development and submission process.However,the establishment and application of such platforms impose higher demands and challenges on the applicants'understanding of processes and production experience.This article focuses on key stages such as preliminary risk assessment,establishment and application of viral clearance process platform,supplemented by relevant case studies,with the aim of providing guidance and practical reference for the development and assessment of this technology.

关 键 词：病毒清除 工艺平台验证技术 多因素正交分析法 案例法 

分 类 号：R95[医药卫生—药学]