Comprehensive Study Identifies a Sensitive, Low-Risk, Closed-System Model for Detection of Fungal Contaminants in Cell and Gene Therapy Products

Comprehensive Study Identifies a Sensitive, Low-Risk, Closed-System Model for Detection of Fungal Contaminants in Cell and Gene Therapy Products

The US Meals and Drug Administration (FDA) regulates manufacturing and testing of superior therapeutic medicinal merchandise (ATMPs) to make sure the security of every product for human use. Gold normal sterility testing (USP<71>) and different blood tradition methods have main limitations for the detection of fungal contaminants. On this research, we evaluated the efficiency of┬áiLYM […]