Drug Product Intermediates Manufacturing (SDD)
Drug product intermediates are produced at the cGMP facilities in Bend, OR, using spray dried dispersion (SDD) technology, hot melt extrusion, fluid bed or melt-spray-congeal processing. Our facilities are designed to support compounds with a wide range of safety classifications and accommodate the use of processes employing organic solvents, e.g. spray-dried dispersions and fluid bed coating of multiparticulates.
Capsugel has phase-appropriate processing equipment in place for integrated design through clinical, small and large-scale commercial production dependent upon processing technology.
Spray-Dried Dispersion Manufacturing
Many promising compounds have low aqueous solubility, and require enabling technology and formulations to enhance oral bioavailability. Amorphous solid dispersion approaches utilizing SDD technology offer a proven and highly flexible approach to significantly improve the bioavailability of promising compounds.
Pioneered by Bend Research, our SDD technology platform incorporates compositions, processes and dosage forms designed to meet performance, stability and manufacturability requirements for a diverse range of compounds. Capsugel scientists, engineers and product development teams have formulated and advanced a diverse range of compounds and expanded the application space for the technology.
Drug product intermediates based on SDD technology can be formulated into capsule, tablets and other solid dosage forms. With our integrated product development approach, Capsugel can efficiently manufacture SDD formulations for all stages of development from preclinical, early- and late-phase clinical, and commercial production of either bulk drug product intermediate or finished dosage forms. Based on intensive science-of-scale studies, Capsugel engineers have designed and developed proprietary phase-appropriate spray dryer equipment and processing techniques to ensure efficient and rapid scale-up.
SDD Center of Excellence (Bend, OR)
Capsugel’s Center of Excellence for solid dispersions and SDD technology is located in Bend, OR, and includes the largest integrated pharmaceutical SDD capacity in North America.
Formerly Bend Research, the site serves a global market with integrated product design, development and manufacturing for a range of enabling technologies inclusive of SDD. With more than 20 years of SDD-based formulation and manufacturing experience, specialized spray dryer designs and processing techniques are in place to ensure rapid and efficient product development to commercialization of a diverse range of compounds.
Dedicated spray-drying capacity in both non-GMP and cGMP environments is in place, as well as isolation capabilities to accommodate high potency compounds. Three pharmaceutical spray dryers are in place for commercial-scale production. Innovative dryer design and manufacturing plant technology is incorporated for significantly improved product throughput that minimizes cycle times and maximizes productivity
- Mini spray drying equipment for feasibility assessments and prototype development with API requirements as low as 100 mg
- A non-GMP development facility to support rapid product development from early design to clinical manufacture
- Small- to mid-sized and high-capacity spray dryers for scale-up, QbD studies and production of toxicology supplies
- Commercial-scale spray drying in non-GMP for seamless process development and commercial scale-up to GMP environment
- GMP production capability for manufacture of registration lots, commercial launch and ongoing supply of drug product intermediate
The Bend site has one of the world’s largest high containment spray dryers for handling potent and highly potent compounds.