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Development Services

Capsugel Dosage Form Solutions offers the full breadth of preformulation and formulation development services at each of its co-located product development and manufacturing sites - a critical advantage in ensuring accelerated product development from concept to clinic and commercial-scale production.

Staffing at these co-located sites includes Analytical and Quality personnel to further ensure late-stage development proceeds efficiently. 

Late-stage development is critical in ensuring quality by design (QbD) and robust dosage form manufacturability.

We have drawn upon our collective experience in advancing hundreds of compounds to late-stage development to develop robust best practices and QbD principles. Specialized capabilities are in place to handle controlled substances, hormones and high-potency (OEB-4/5) drugs.

Early Development Services Late-Stage Development Services
API handling protocols Manufacturing process development
API characterization QC methods
Excipient compatibility testing and selection Analytical method optimization, qualification and validation
Pre-formulation and formulation development Cleaning methods / verifications
Analytical method development and qualification Product release and stability testing
Release and stability testing Clinical trial material manufacture
Clinical trial material manufacturing QC / QP release
IND / IMPD dossier support Regulatory dossier support

 

Capsugel Dosage Form Solutions development sites are equipped with a full range of formulation development and process analytical capabilities, including:

Fully equipped pilot plant for formulation development include a range and scale of equipment for feasibility assessments through clinical trial manufacture of most oral solid dosage forms.

Equipment Processing Highlights
Proprietary filling and sealing equipment for liquid-fill hard capsules Tablet laser drills
Proprietary pharmaceutical spray dryers Dry and wet (high-shear) granulators
Twin-screw mixers / hot-melt extruders Particle size reduction (wet and dry)
Melt-spray-congeal processing Specialized capsule coating
Fluid-bed coaters Soft-gel manufacturing

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