(258) Manufacturing Process Design: Scaling up studies for success
Introduction: The present case study provides details on activities that can be performed in the Formulation& Analytical Development laboratory of ThermoFisher, Monza (Italy) to support the scale-up of sterile RNA-based drug products (DP) on GMP lines.
Learning Objectives:
Understand the impact of using gamma-irradiated disposable assembly on drug product stability
Show the importance of performing process study ahead a production of Drug Product at scale
