Manufacturing

The Product Development and Manufacturing (PDM) Core offers product translational services to academic, government, and industry partners for the development and manufacture of vaccines, therapeutics, and diagnostics used in preclinical animal studies and phase I and II human clinical trials. The PDM Core's product development department provides prelim product characterization and formulation, The PDM Core’s quality system, maintained by the Quality Control and Quality Assurance Departments, provides testing, validation, and auditing for GLP and cGMP-compliant projects, as required by the Code of Federal Regulations. Product release testing of manufactured products, including safety, stability, purity, potency, identity, and sterility testing, is performed as per the United States Pharmacopeia (USP), where applicable. Procedural validation is performed by documentation review and systematic inspections. Auditing services for GLP projects are available for outside projects.