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Dry Powder Inhalers

FROM DEVELOPMENT TO FULL COMMERCIAL-SCALE MANUFACTURE AND PACKAGING

Catalent offers best-in-class commercial-scale powder and capsule manufacture for Dry Powder Inhalers (DPIs) out of the Boston, MA facility. The site is equipped with modern, industry-leading commercial spray dry dispersion, powder encapsulation and blister packaging technologies, as well as clinical scale manufacture and on-site QC labs. With a proven track record, our Boston-area team are experts in spray dry inhalation technology.

The Morrisville/RTP, NC facility, Catalent’s global development and analytical center, complements the capabilities out of the Boston-area site, providing complete DPI development services from early pre-formulation to final product release testing. With industry-recognized experts in inhalation product development and characterization, Catalent offers end-to-end support throughout the product’s lifecycle. In addition, the NC site also offers early clinical-scale DPI capsule filling for clinical phases I and IIa.

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CATALENT BENEFITS

  • Featuring GEA Niro spray dry technology including PSD-7 scale, the largest size CGMP pharmaceutical use spray dryer in North America
  • Additional PSD-4 and PSD-1 scale spray dryers.
  • Top-tier capsule filling and blister packaging lines
  • Significant recent investment
  • Experience with DPI commercial launch and execution
  • Over 30 years of experience in supporting development of inhalation products
  • Supporting commercial, clinical and development-scale with flexible batch sizes

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CATALENT SERVICES

  • DPI Dose Form Development
    • Feasibility studies
    • API screening
    • Pre-formulation / solid state
    • Formulation of low- and high-dose powder systems
    • Formulation of carrier-based or pure drug aggregated systems
    • Evaluation of moisture effects on powder properties, formulation stability, and aerosol performance
    • Powder evaluation and characterization
    • Compendial analysis
    • Device evaluation, selection and testing
    • Method and process development, optimization, transfer and validation
    • Drug-excipient and drug-container compatibility
    • Characterization of aerosols
    • CGMP compliance
  • Commercial, Clinical and Development-Scale Manufacturing
    • Scalable manufacturing to take your product from early phase clinical to commercial scale
    • PSD-7, PSD-4 and PSD-1-scale spray dryers
    • Harro Höfliger high-speed encapsulation lines
    • Pharmaworks high-speed blister packaging lines and PharmaMED blister sleeving
    • Clinical-scale Harro Höfliger and Pentapack lines
    • Development-scale Harro Höfliger Omnidose and Mettler Toledo Quantos systems
    • Dedicated commercial and clinical-scale suites
    • ISO 8 production suites (previously class 100,000) with dedicated air handling
    • Warehousing
    • Vendor qualifications
    • FDA & EMA approved
  • Product and Analytical Testing
    • Manufacturing validation support (process and cleaning validation)
    • QC release testing
    • Aerodynamic & geometric particle sizing
    • Characterization of aerosols
    • Dose delivery
    • Stability studies (ICH and custom conditions)
    • Extractable and leachable studies
    • Elucidation of impurities and degradation products
    • Risk assessment testing and support
    • Microbial enumeration, sterility and endotoxin testing