Introduction to Lyophilisation for Biopharmaceutical Fill-Finish Operations

This course will provide an introduction to the theory and practice of biopharmaceutical lyophilisation. It will first introduce learners to the key principles of lyophilisation before focusing on its use in the context of sterile fill-finish manufacturing. What are the critical process parameters to consider during a fill finish operation of a lyophilised biologic? How do these relate to critical quality attributes? How does formulation impact on the process? These questions and others will be considered during the course which will be delivered through a combination of classroom lectures and workshops supported by hands-on practical sessions with our pilotscale lyophiliser (Lyobeta 3PS), fill finish line and other supporting equipment.