We perform solubility studies, excipient compatibility studies, and thermotropic characterization of formulations. We develop lyophilization cycles for freeze-dried products and offer parenteral manufacturing services to support drug development. Our team can perform extractable/leachable studies in support of container/closure selection and can develop and validate the analytical methods needed to support your project.
To understand your drug’s properties, we measure lipophilicity, screen polymorphs, evaluate the effect of pH and the Arrhenius kinetics. We evaluate the solubility and stability of the compound and check for compatibility with excipients. Once a lead formula is developed, we execute protocols to collect required CMC data for your regulatory filings.
Elements of our process development program include component interaction studies, homogeneity evaluations, and storage time determinations. All process development work is conducted using protocols that can be used to support CMC regulatory filings.
Let us validate the steam sterilization process for your drugs and devices. Our validation engineers have many years of experience in validating different cycles of an autoclave using temperature mapping and biological indicators.
For parenteral products, our team can transfer the manufacturing process from the lab into manufacturing. We evaluate critical process parameters and prepare batch records prior to scale up. We can even transfer methods from your facility or other CMOs into our facility.
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
