Capabilities for Every Phase of Drug Development
Start your drug development journey with UI Pharmaceuticals. Our comprehensive CDMO services can advance your project from formulation to commercialization. UI Pharmaceuticals serves pharmaceutical, biotech, pediatrics, oncology, and research organizations worldwide, offering drug product CDMO services with a focus on early-stage development, clinical manufacturing, and small-scale commercial production. With over 60,000 square feet of state-of-the-art manufacturing and laboratory space, we accelerate early-stage programs as well as meet the specialized needs of our commercial clients.
Formulation Development
UI Pharmaceuticals formulation development department offers both non-sterile and sterile capabilities and performs fit-for-purpose studies including solid-state characterization of active pharmaceutical ingredients, solubility and stability studies, excipient compatibility studies, lyophilization cycle development, drug product characterization and stability.
Sterile Manufacturing
Sterile Products Manufacturing includes two areas both equipped with liquid vial filling and lyophilization lines. Our newest facility features two fully automated fill lines contained in ISO 5 isolators and equipped with TelStar Lyomega 80ST lyophilizers, allowing us to manufacture larger clinical and commercial lots. UI Pharmaceuticals can support batch sizes up to 200 L and vial fills from 1 mL to 100 mL, with capabilities to handle DEA Schedule I – V, cytotoxic and potent compounds.
Non-Sterile Manufacturing
With six manufacturing suites, UI Pharmaceuticals can handle solids, liquids, and semi-solids, including high-potency compounds. Capabilities cover clinical and small-scale commercial production, including tablets, capsules, powder in bottle, over-encapsulation, oral suspensions and transdermal patches.
Analytical Services
We offer comprehensive analytical services, including robust method development, ICH-compliant method validation, and product release and stability testing. Our stability storage capabilities span from -80°C to 40°C/75% RH, and we offer photostability, in-use stability, and freeze/thaw cycling studies.