Bulk Lyophilization Development

Lyophilization services: Evaluation of critical bulk freeze-drying parameters and development of freeze drying cycles of bulk APIs or investigational bulk drug intermediates to obtain a solid lyo cake or free-flowing lyo powder appearance, either filled into permeable lyophilization bags / trays or into conventional freeze drying stainless steel trays.

Lyophilization of bulk material is usually a need to either conserve defined intermediate or drug substance material for storage and later use, or for preparation and proportioning of particular intermediate products of various processing steps in a manufacturing process.

Using state-of-the-art technologies, we make available to our clients the development approaches for bulk lyophilization at pilot scale that can be smoothly transferred and up-scaled to large scale manufacturing. We put particularly an eye on the feasibility of freeze-drying under technically acceptable process parameters, and to efficiently manufacture an acceptable bulk lyophilizate under appropriate process conditions of freeze drying. Additionally, we have long term experience in lyophilization of organic solvent-based formulations.

ProJect Pharmaceutics provides suitable freeze-drying specifications for bulk lyophilization within the following primary packaging/container closure materials:

Cake appearance is trimmed to either achieve a solid lyo cake, or alternatively a loose, free-flowing lyo powder with a homogenous particle-size distribution.

Defining optimized parameters for freezing, sublimation and secondary drying as well as a design space for critical process parameters will enable a smooth scale-up and transfer into commercial bulk manufacturing. Partners for commercial bulk manufacturing are available.