LyophilizationWorld’s laboratory set-up is designed for flexibility in terms of size, type, duration and scheduling of freeze drying runs. This flexibility has proven ideal for start-ups or smaller organizations whose manufacturing runs are not yet large or consistent enough to justify the capital expense of onsite production facilities.
Small Batch Production
SPScientific pilot freeze dryers, adaptable to any specific conditions of production 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 freezing (including own technologies for controlled nucleation), sublimation and drying parameters and run an in-depth analysis of lyophilizates by own scanning electron microscopy (SEM).
We determine the critical lyophilization parameters and modulate those by means of robustness studies to explore the design space for the process (Quality-by-Design). Our goal is a technology transfer to clinical / commercial drug product manufacturing without defective batches.
LyophilizationWorld experts support customers’ product development to achieve product stability and improved shelf-life of products destined for clinical or commercial applications. Most notably, our scientists have garnered broad experience in the handling of the growing class of more complex molecules such as Peptides and mABs (mono-clonal Antibodies), in addition to common small molecules. Our production freeze drying capabilities are also utilized by customers to achieve an immediate production capability, particularly useful where equipment has not been purchased or bigger production are needed. It also enables the product and recipe to be tested under our quality experience.