Lyophilization consists of a freezing step, primary drying where sublimation occurs, and a secondary drying step to remove absorbed water molecules. We have baseline conditions that can serve as a starting point for your product. A design of experiment (DOE) approach can be used to optimize each step of the process.
We customize our approach based on your drug’s phase of development. We can quickly develop a lyophilization cycle that is well suited to produce small batches for preclinical or early clinical studies. As batch sizes increase at later phases of development, we can optimize the cycle to minimize production time and reduce manufacturing costs.
We use a VirTis 25L Genesis EL freeze dryer with sample thief and Maestro software for development work. DSC is available for analysis of thermal properties, and a LYOSTATZ freeze drying microscope system is available for process visualization.
Nitto Avecia Pharma Services has state-of-the-art chemistry labs and analytical instrumentation capable of analyzing many different product and formulation combinations. Samples generated during the development and optimization work can be analyzed in house for attributes such as moisture content and impurity profile. We can also perform stability studies on drug product using the final, optimized cycle.
10 Vanderbilt Avenue
Irvine, CA 92618
Tel: (949)-951-4425
Fax: (949) 951-4909
6 Vanderbilt Avenue
Irvine, CA 92618
4 Chrysler
Irvine, CA 92618
