Our integrated product development and manufacturing model includes a range of finished oral solid dosage forms. Our specialized technologies are utilized to design, develop and manufacture immediate release, delayed release and controlled release tablet and encapsulated products. Encapsulated products include solid capsule fill (powder and multiparticulates) as well as specialized liquid-filled hard capsules and soft gels. Our clinical phase and commercial scale encapsulation equipment is also utilized for dry powder inhaler-based products produced with spray dry processing technology.
Capsugel’s state-of-the-art cGMP manufacturing sites are established in the United States and Europe. Manufacturing is phase-specific with specialized processing in place to ensure that finished dosage forms can be provided at any stage of the product development cycle – proof of concept studies, clinical trial material, and commercial quantities. Each site is fully staffed and equipped to provide full preformulation, formulation, and analytical/characterization services.
Capsugel’s proprietary Xcelodose™ Precision Powder Micro-dosing Systems are in place to support clinical trial manufacture utilizing API-in-capsule technology. This approach to early stage clinical studies has been proven to significantly reduce time to clinic, and is a preferred approach for preclinical, phase I and phase II studies. Capsugel’s Tampa, USA and Plöermel, France sites have industry-leading Xcelodose capacity and expertise in place to produce clinical trial material using this approach. And our clinical supply solutions include primary and secondary packaging, labeling, kit assembly, and global distribution.
All Capsugel finished dosage form manufacturing sites have an excellent inspection record by the U.S. FDA, EMA and other regulatory agencies. Our manufacturing network is also designed to support highly potent compounds, with Capsugel Bend, USA site equipped to accommodate the use of processes employing organic solvents, such as spray drying and fluid bed coating.