The Consideration on Key Quality Management Points in Production System of CAR-T Products
Based on the six major systems of drug production quality management and the analysis of the typical production processes of chimeric antigen receptor T cell(CAR-T)products,this review analyzes and discusses the particularity of the CAR-T product production system and the corresponding key quality management points from four main aspects,namely product production process quality control,process validation and aseptic processing simulation test,contamination and cross contamination control in the production process,and production related deviation and change control.This review provides some references to cell therapy product manufacturers especially CAR-T product manufacturers,to further improve production system quality management,and also provides a reference to production inspection and quality audit.
chimeric antigen receptor T cell(CAR-T)cell therapymedicine productionquality managementbiological product
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