Research on the development trend of viral safety control technology and requirements for biotechnology products:taking ICH Q5A(R2)as an example
SAI Wen-bo
YU Peng-li
WEI Wei
Abstract：ICH Q5A(R1),Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin,is a special guideline for the control of viral safety of specific biotechnology products,which is of great significance for the research and development and manufacture of recombinant proteins,genetically engineered viral vectors and other pharmaceutical products.The guideline has been formally implemented since 1999,and after 25 years of rapid development of biotechnology products,it is no longer adapted to the new needs of industrial development.The revised version,ICH Q5A(R2),was officially signed and implemented at the end of 2023,which provides more methods,more flexibility and a clearer decision tree for virus safety control of biotechnology products under the continuous emergence of new products and technologies.Relying on ICH Q5A(R2),this paper will make discussion from six aspects,including the scope of applicable products,potential sources of viral contamination and pre-treatment of raw materials for production,detection of viral exogenous factors,etc.,and focus on analyzing the impacts of the application of advanced technologies and concepts,such as the next generation sequencing,prior knowledge,and continuous manufacturing on the technical requirements of viral safety and control of biotechnology products,with a view to providing references for readers.
Keywords：viral safety controlbiotechnology productsnext generation sequencingprior knowledgevirus clearance processescontinuous manufacturing
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：5( 566-570 )