Comprehensive Study Identifies a Sensitive, Low-Risk, Closed-System Model for Detection of Fungal Contaminants in Cell and Gene Therapy Products
Nicole E. Putnam, Anna F. Lau
Abstract
FA Plus 32.5°C can provide high fungal sensitivity, statistically comparable to USP<71>, when tested against a diverse range of environmental fungi. Our study fills a much-needed gap in biopharmaceutical testing and offers a favorable testing algorithm that maximizes bacterial and fungal test sensitivity while minimizing risk of product contamination associated with laboratory handling.
Topics & Concepts
BottleFood and drug administrationMicrobiologyBiopharmaceuticalAgarBiologyCleanroomContaminationBiotechnologyFood scienceBacteriaPharmacologyPhysicsEcologyQuantum mechanicsEngineeringMechanical engineeringGeneticsViral Infectious Diseases and Gene Expression in InsectsBiosimilars and Bioanalytical MethodsBacillus and Francisella bacterial research