Interpretation of the"Technical Guideline for Platform Validation of Viral Clearance Processes in Clinical Trial Applications for Therapeutic Recombinant Protein Products"
HU Ying-ying
SAI Wen-bo
Abstract：Viral clearance validation is a critical component of viral safety control for therapeutic recombinant protein products.In the more than twenty years since the implementation of ICH Q5A(R1),both regulators and industry have accumulated considerable experience with some viral clearance unit operations that demonstrate robust performance.Consequently,the concept of platform viral clearance validation has been introduced for formal consideration in the upcoming ICH Q5A(R2)guideline.To standardize platform validation studies for viral clearance at the clinical trial application(CTA)stage,clarify the relevant technical requirements,and align with ICH Q5A(R2),which outlines the requirements for market authorization applications,the Center for Drug Evaluation(CDE)of the National Medical Products Administration(NMPA)released the"Technical Guideline for Platform Validation of Viral Clearance Processes in Clinical Trial Applications for Therapeutic Recombinant Protein Products"in January 2024.This article interprets the main content and key considerations of the guideline,drawing on the drafting background and expert consultation feedback during its development,with the aim of facilitating industry understanding and application of the guidance principles.
Keywords：modular viral clearance estimationtherapeutic recombinant protein productsvirus filtrationlow pH virus inactivationsolvent/detergent virus inactivation
Publication Date：2025-12-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2646-2651 )