Lyophilization Formulation and Process Development

Dr. Jayasree (Jay) M. Srinivasan

Course description

Lyophilization is a very common technique used in preparing finished drug products. Yet there are many problems that can arise in production if the process has not been carefully developed. Without a good understanding of the development of this formulation and the process, these problems can readily occur.

This accredited course will provide a brief review of the basics of Lyophilization. Participants will be able to dive deep into understanding how to select excipients for formulations, solution formulation development, thermal analysis, and lyophilization formulation development.

Discussions will then address how to develop ideal lyophilization process conditions through optimization of primary and secondary drying. The lecture will then go over the first principles of heat and mass transfer in the process. Participants will also learn to establish a residual moisture specification.

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

• Understand the role of formulation excipients and apply knowledge in judicious selection of excipients
• Appreciate differences between small and large molecules and develop formulations accordingly
• Describe the process parameters and development of efficient process controls
• Demonstrate the ability to use process conditions to optimize primary drying
• Establish connection between secondary drying and residual moisture levels and how to optimize the latter