Capsugel Dosage Form Solutions uses an integrated development program to advance compounds from feasibility and design to commercial manufacture of finished dosage forms. This integrated process - combined with our breadth of technologies - provides our customers with a single partner throughout the development process, thereby reducing project time, cost, complexity and risk. Co-located product development sites in the US, UK and France further enable rapid and optimized product design and development.
A global network of eight world class manufacturing facilities, approved by international regulatory agencies, provides clinical and commercial scale manufacturing for global pharmaceutical and health & nutrition clients around the world. Dedicated non-GMP development suites are in place for pre-clinical feasibility assessments. Dedicated high containment suites are also in place to handle highly potent active ingredients to OEB 4-5 and controlled substances from pre-clinical and clinical studies through commercial manufacture.
Capsugel's flexible manufacturing footprint support product supply throughout the development cycle across our technology platforms, inclusive of:
- Micronization / nano-milling of active ingredients
- Drug product intermediate using spray dry dispersion or hot melt extrusion technology
- Multiparticulates using melt-spray-congeal processing, fluid bed bead layering, extrusion / spheronization, or mini-tablets
- Encapsulation (powder or multiparticulates) in either capsules or sachets
- Liquid fill hard capsules or soft gels
- Tableting (immediate release, matrix, bi-layer, osmotic, chewable / orally dissolving) and coating
Primary and secondary packaging is available for clinical trial material and small-scale commercial manufacturing. Global clinical supplies distribution and logistics is also available, inclusive of cold chain capabilities, through our Xcelience Division.
- Eight commercial manufacturing sites in the U.S., Europe and Japan
- FDA, EMA and MHRA-inspected and accredited sites
- Co-located pharmaceutical product development and commercial manufacturing sites in Bend, OR (US); Tampa, FL (US); Ploërmel, France; and Edingburgh, Scotland
- State-of-the-art micronization center of excellence in Quakertown, PA (US) (Powdersize Division)
- Largest commercial pharmaceutical spray drying capability in the US (Bend Research Division)
- Largest dedicated manufacturing facility for liquid-filled hard capsules (Encap Drug Delivery Division - Edinburgh, Scotland)
- Non-GMP and GMP facilities with separate clean room suites
- High containment capability to OEB 5
- Tablet, multiparticulate and capsule coating (and banding) capabilities
- Primary and secondary packaging
- Clinical supplies packaging, kitting, distribution and logistics (Xcelience Division - Tampa, FL and Birmingham, UK)