Since lyophilization is an expensive process, it is of high importance to develop economical freeze-drying cycles suitable for larger-scale production of the product. At LyophilizationWorld we are highly experienced in the development and transfer of lyophilization processes for pharmaceutical products.
Our Lab is equipped with freeze-driers of various sizes and drying capacities, which allows us addressing not only freeze-drying cycle development in lab scale freeze-driers, but also scale-up questions already at an early stage. From the very beginning of process development we consider the suitability of the lyophilization cycle for a later scale up and transfer to the production facilities of our customer.
For the lyophilization cycle development our Lab is able to Identify and Optimize the appropriate process parameters for the following steps:
freezing phase: freezing rate, nucleation, shelf temperature during freezing, duration of the freezing step
primary and secondary drying phases: shelf temperature, pressure, ramp from freezing step to primary drying step and from primary to secondary drying
stoppering phase: vacuum, pressure and time
In combination with our experience in analytical and (formulation) development, a complete package can be offered to our customers.