Lyophilization of Pharmaceutical Drug Products

Dr. Jayasree (Jay) M. Srinivasan

Course description

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.

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.

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. This will be followed by a demonstration on the use of the freeze-dry microscope by The McCrone Group.

At the end of the course, you 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.

This intensive training includes a demonstration conducted by The McCrone Group, Inc.

Upon completion of this course, you will be able to:

• Demonstrate appreciable knowledge in the area of lyophilization
• Describe the role of each component present in drug products, both small and large molecules and apply knowledge in judicious selection of excipients
• Review the process parameters and development of efficient process controls
• Identify analytical techniques for drug product characterization
• Establish connection between secondary drying and residual moisture levels and how to optimize the latter
• Compare and contrast lab scale versus production manufacturing of parenterals