Lyophilization Development
At Formatech, lyophilization development begins with the identification of a product-specific liquid matrix and an assessment of its thermal properties using modulated differential scanning calorimetry. Determining the glass transition temperature and the eutectic point are critical data used to set initial drying temperatures. Systematically, parameters such as drying temperatures, pressure, ramp rates and hold times are varied in an effort to optimize the lyophilization cycle. The final lyophilization process should yield product that has low residual moisture, forms a solid and attractive cake, reconstitutes readily and completely, and arrests physical degradation.
Lastly, it is important to develop a lab scale process that is compatible with and operates under parameters that are compatible with commercial scale lyophilizers. Formatech has significant experience in developing processes that have been transferred successfully to cGMP production lyophilizers — both in-house and to third-party CMOs.
To request more information on our lyophilization development services, please click here.
