The University of Iowa Pharmaceuticals (UIP) is a Food and Drug Administration-registered pharmaceutical manufacturing facility, which occupies 24,000 square feet at the University of Iowa College of Pharmacy and 7,000 square feet at the University of Iowa Research Park. 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 38 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. Senior scientific staff average over 20 years of experience. 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).
UIP is capable of producing most types of pharmaceutical dosage forms. These dosage forms include sterile injectable solutions; sterile lyophilized (freeze-dried) powders; topical and oral solutions, emulsions, and suspensions; tablets (uncoated and film or functional coated); and hard gelatin capsules (powder or hot melt filled).
The sterile processing area is capable of handling batch sizes ranging from a few hundred to 5,000 or more finished units (typically vials). This area is supported with a hot loop Sterile Water for Injection, USP system, 48 square foot Hull lyophilizer, Pure Steam Generator, Flexicon Filling, Stoppering, and Crimp Sealing Machines and other modern sterile processing machinery. UIP has the capability to terminally sterilize products. Once products are filled and sealed into vials, the products and vials are 100% visually inspected and can be labeled according to client specifications.
The solid dosage form processing area is capable of handling batch sizes ranging from a few hundred to several hundred thousand dosage units (typically tablets or capsules). Processing capabilities include micronization, milling, sieving, high shear blending/granulation, roller compaction, low shear blending/granulation, fluid bed granulation/coating/drying, oven drying, hard capsule filling, tablet compression, powder filling, and tablet or capsule coating. The facility is equipped with supplied breathing air, allowing full, air-tight protective gowning; has negative room pressure differentials; and single-pass, high-efficiency filtered supply and exhaust air. Each potent material handling room is equipped with a two-stage shower and gowning room. The area is fully temperature and humidity controlled, with the capability to depress humidity levels when required for hygroscopic or moisture sensitive materials.
The solid dosage forms staff has extensive experience with the production of blinded comparator products which are produced using a variety of means, including placing products into empty capsule shells and overfilling with inert powders, where appropriate, milling commercially available products and filling the resultant powder into empty capsule shells, removing ink logos from commercially available tablets or capsules, film coating over existing brand marking, or production of look alike placebo dosage forms.
The non-sterile liquids and semi-solids staff is able to prepare oral solutions and suspensions and a variety of topical dosage forms such as creams, gels, lotions, and ointments. Typically these products are packed into bottles, jars, or tubes.
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 for batches made by UIP and can also be performed on products made at other sites. Stability testing is performed according to FDA-ICH guidelines, client approved protocols and standard operating procedures. Available stability storage conditions include -80ºC, -20ºC, 2 to 8ºC, 25ºC/60% RH, 30ºC/65% RH, 40ºC/75% RH, xenon-arc light cabinet, and customized conditions (such as freeze/thaw cycling).
The University of Iowa Pharmaceuticals (UIP) has a rigorous quality assurance program designed to ensure that FDA Good Manufacturing Practices (GMP) are met.
Analytical Assay Development and/or Laboratory Service, Chemistry/Manufacturing/Controls, Clinical Supplies/Distribution/Packaging, Dissolution Testing, Formulation Development, GMP Compliance, Stability Studies/Testing, Standard Operating Procedures