Led by Scott Freeswick, the service includes three principal units: the Pharmaceutical Product Service, the Clinical Grade Production service, and the Pharmacy Investigational Drug service.

Pharmaceutical Product Service

Led by Mark Klang ([email protected]), this group is responsible for issues related to drug formulation, stability, and compatibility. Our services include, but are not limited to, formulation, analysis, and evaluation of drug release rates; predicting drug interactions; and determining the compatibility and physical stability of medications used in clinical investigations.

Clinical Grade Production Service

The Clinical Grade Production service, led by Govind Ragupathi ([email protected]), is a class 10,000 cGMP facility responsible for the bulk product manufacture, purification and characterization of clinical-grade drug substances and drug products. In addition, we offer vialing of sterile investigational products such as peptides, proteins, antibodies, antibody drug conjugates, carbohydrates and adjuvants. The CGP core also conducts either in-house or with validated contract vendors the drug product release tests which are required for the investigational product release for clinical use.

Pharmacy Investigational Drug Service

This unit, led by Gerald O’Neill ([email protected]), provides a mechanism to develop, procure, prepare, and validate the preparation and packaging of investigational drugs for clinical use and distribution. The Pharmacy Investigational Drug Service reviews the labeling, packaging, and quantity of investigational agents and for accuracy compares this information with the manufacturing batch record, IRB protocol, and pharmacy computer setup.