Developing a Transferrable Lyophilization Protocol using a MicroFD® with LyoPAT®
Abstract: This webinar will demonstrate how the MicroFD with LyoPAT can be used to both develop an optimized lyophilization protocol and then transfer the protocol to a pilot or production scale system. The MicroFD is an advanced, small-scale research and development freeze dryer that is capable of using as few as 7 vials to develop an optimized lyophilization protocol and facilitating the transfer of the developed cycle to a pilot or production scale freeze dryer. Using a heat flux sensor, the LyoPAT software on the MicroFD is able to determine the critical process parameters that are relevant in developing and transferring a lyophilization protocol, such as Kv, Rp, and sublimation rate. The MicroFD is integrated with three LyoPAT optimization features, FreezeBooster controlled nucleation, AccuFlux post-nucleation heat flux control, and AutoDry closed-loop primary drying optimization, which collectively allow for the optimization of both the freezing and primary drying phases of a freeze-drying cycle. The critical process parameters that are determined by the LyoPAT software can then be used to transfer an optimized protocol to a larger pilot or production scale system.
Instructor: Spencer Holmes, Application Engineer