ProJect Pharmaceutics GmbH

Lyophilization Process Development

Lyophilization Cycle Development and Technology Transfer

Lyophilization of pharmaceuticals: We, as a freeze drying company, take new paths in lyo-cycle design to quickly and efficiently generate a dry and elegant lyophilizate without compromising process safety and stability of the product. 

Our profound expertise in lyophilization process development covers freeze-drying services of specialty areas such as:

Three high-end HOF pilot freeze dryers, equipped with process analytical technologies, and adaptable to any specific conditions of large-scale manufacturing, are implemented in dedicated labs for the rational design of reliable and cost-effective freeze-drying cycles. After physicochemical characterization of the final drug product formulation, we define the ideal i) freezing (including annealing and own technologies for controlled nucleation), ii) sublimation (including own technologies for critical pressure scanning and collapse monitoring) and iii) drying parameters and run an in-depth analysis of lyophilizates by own scanning electron microscopy (SEM).

We determine the critical lyophilization process parameters and modulate those by means of robustness studies (lyo process robustness testing) to explore the design space for the process (Quality-by-Design). Our objective is a technology transfer to clinical / commercial drug product manufacturing without defective batches.