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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.
|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