Bulk Lyophilization Development
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 bulk manufacturing.
We put particularly an eye on the feasibility of freeze-drying under technically acceptable process parameters, and to efficiently manufacture an acceptable freeze dried 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 solution lyophilization within the following primary packaging/container closure materials:
- Original stainless steel (SS) trays as used at the commercial plant
- Customized stainless steel (SS) trays mimicking 1:1 the commercially used trays’ dimensions
- Customized stainless steel (SS) pilot trays mimicking proportionally the commercially used trays’ dimensions including scale-up factors
- Gore Lyoguard™ single use trays
- Teclen Lyoprotect™ single use bags for bulk freeze drying within a lyophilization bag
- Teclen Lyoprotect™ single use trays
Cake appearance is trimmed to either achieve a solid lyo cake, or alternatively a loose, free-flowing lyophilized powder with a homogenous particle-size distribution. The freeze drying of porous powder can be conducted particularly elegant in lyophilization bags.
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. Business partners for commercial bulk manufacturing in Europe are available.
