Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

Lyophilization offers unique properties for delivering critical parenteral drugs. Therefore, developing the formulation and the manufacturing process is challenging. Only through a clear identification of the process and key excipients can a robust formulation be developed and manufactured.

This intensive, 8-hour accredited ON DEMAND training including demonstrations conducted by The McCrone Group, Inc. will be presented in two unique segments. The first session introduces participants to the basics of lyophilization and why we lyophilize drug products. Typical approaches to developing a drug product formulation and lyophilization process development will be discussed. For the first demonstration a representative from The McCrone Group, Inc. will give an overview lecture on particle identification using polarized light microscopy and scanning electron microscopy.

Next, after a brief review of the basics of lyophilization, participants will be able to dive deep into understanding selection of excipients for formulations, solution formulation development, thermal analysis, and lyophilization formulation development. Participants will then learn how to develop ideal lyophilization process conditions through optimization of primary and secondary drying.

Discussions will then address the first principles of heat and mass transfer in the process. Participants will also learn to establish a residual moisture specification. The final demonstration will be on the use of the freeze-dry microscope by The McCrone Group, Inc.

At the end of the course, participants will be able to identify analytical techniques that are available to characterize drug products. The final goal of the course is to offer an understanding of the challenges involved in aseptic manufacturing and transfer of lyophilization cycles from R&D to Production.