University of Iowa Pharmaceuticals

Therapeutic Approaches: Biologics, Small Molecules, Vaccines, Antibodies, Drug Delivery

Therapeutic Areas of Expertise: Cardiology, Immunology, Infectious Diseases, Metabolic Disorders, Neurological Disorders, Oncology, Psychiatric Disorders, Pain, Regenerative Medicine

Center/Program Highlights: The University of Iowa Pharmaceuticals (UIP) is a Food and Drug Administration-registered pharmaceutical manufacturing facility at the University of Iowa College of Pharmacy. UIP provides contract pharmaceutical services including pre-formulation studies, formulation development, clinical supply manufacturing, small scale commercial manufacturing, analytical method development and validation, routine quality control analysis, stability studies, and active pharmaceutical ingredient and excipient release testing. UIP is licensed by the DEA to handle controlled substances (Schedules I ? V) and is capable of handling potent and cytotoxic compounds. UIP has been developing formulations, manufacturing products, and conducting analytical testing in compliance with Good Manufacturing Practices for over 37 years. During the past 5 years UIP has manufactured over 1100 batches of product for over 100 different sponsors. Sponsors have included virtual companies, governmental organizations (such as NIH), small to mid sized pharmaceutical companies, research hospitals and universities, and large pharmaceutical companies, from around the world. In addition to our full time staff, UIP has access to the University of Iowa, College of Pharmacy Pharmaceutics Faculty for collaboration through The University of Iowa Pharmaceuticals Development Consortium (UIPDC). UIPDC can be especially valuable when significant formulation challenges such as poor solubility and/or stability are encountered. UIP is capable of producing most types of pharmaceutical dosage forms. These dosage forms include sterile injectable solutions; sterile lyophilized (freeze-dried) powders; oral solutions and suspensions; topical creams, gels, lotions, and ointments; tablets (uncoated and film or functional coated); and hard gelatin capsules (powder or hot melt filled). The analytical method development and validation group has extensive experience developing and validating methods for use in testing active pharmaceutical ingredients (API) and drug products. Methods are developed and validated to analyze in-process, finished product and stability samples, as well as swabs to verify the cleanliness of manufacturing equipment. All validations are performed according to FDA-ICH guidelines, client-approved protocols and standard operating procedures. Routine quality control testing is performed on in-process and finished product samples, as well as rinse or swab samples to verify cleanliness of manufacturing equipment. Stability testing is performed according to FDA-ICH guidelines, client approved protocols and standard operating procedures. The University of Iowa Pharmaceuticals (UIP) has a rigorous quality assurance program designed to ensure that FDA Good Manufacturing Practices (GMP) are met.

Sources of Funding: Revenue

Industrial Partnerships: Each project typically has a different industrial partner. Due to confidentiality issues we are unable to share specific details of the various relationships.

Website

Institutional Affiliation(s): -

Address:
115 South Grand Avenue, G-20
Iowa City
Iowa, 52242
United States

Center/Program Start Date: 1974

Number of Employees: 50