How A CDMO Achieves Finished Product Lyophilization With Limited And Expensive API

By Bryan Braxton, Ph.D., Senior Director, Aseptic R&D, Pii

Stability is an inherent challenge in the early stages of development for both solid and liquid pharmaceutical ingredients. Lyophilization may the answer needed to complete formulation development and advance your candidate to Phase I clinical trials.

Lyophilization, or freeze drying, is a process in which water is removed from a product after it is frozen and placed under a vacuum, allowing the ice to change directly from solid to vapor without passing through a liquid phase. The process consists of three separate, unique, and interdependent processes: freezing, primary drying (sublimation), and secondary drying (desorption). But lyophilization can be challenging, expensive, and time-consuming.

Agile, cost-effective lyophilization services can accelerate the development of complex drug candidates that present stability challenges. Partnering with an agile CDMO that recognizes these obstacles, and can still formulate a finished product with limited and expensive active supply, is critical.

In this article, explore lyophilization development in the lab, lyophilization cycle development and optimization, and agile scale up.