Developing tailored lyophilization cycles
For lyophilization, customization is key. Every freeze-drying cycle we develop is expertly customized for a specific product and its unique molecular properties – as well as its up- and downstream manufacturing processes.
That tailoring begins with process development and characterization steps carried out with a small-scale laboratory freeze-dryer and small API samples, before scaling to commercial production following qualification and validation. During that process, we rigorously test a wide range of thermal product properties, process/equipment parameters, and packaging factors to identify the optimal temperature, pressure, and batch size for each molecule.