Case study on the application of validation technology in viral clearance process platform
CHEN Hao
HE Wu
Abstract：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.
Keywords：virus clearanceprocess platform validation technologymultifactorial orthogonal analysis methodcase study method
Publication Date：2025-03-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 602-607 )