Discussion on Viral Safety Control of Antibody Products
Virus safety control is crucial for the production quality of antibody products.This article summarizes the relevant issues regarding virus safety control of antibody products in pharmaceutical reviews and on-site inspections.Based on the latest revised ICH Q5A(R2)guidelines,the development of continuous manufacturing technology,and the technical requirements for platform validation,this article analyzes and discusses the virus safety control of antibody products,covering aspects such as facilities and equipment,cell banks,raw materials,auxiliary materials and consumables,upstream production processes,downstream purification processes,change control,etc.,in order to provide references and guidance for relevant production enterprises and regulatory agencies.
antibody productsviral safety controlcell banksunprocessed bulkvirus removal or inactivation
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