Rapid Sterility Methods for CAR T-cell Therapies
A combination of rapid sterility methods with the industry standard compendial method should ensure maximum safety.
Pharmaceutical Compounding Calculations in a Workplace Environment
An ordered process describing calculations activities for compounded dosage forms is described.
Exploring Multimodal Biomanufacturing and Its Drivers
Application of the Risk Evaluation Matrix as per USP <665> and <1665> for Evaluation of Leachables Risk from Single-Use Components Used in Biomanufacturing
Determining E&L risk from single-use components can be used to build the level of extractable profiling and PERLs.