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OVERVIEW

×îÐÂÉ«ÇéӰƬ Benefits      ×îÐÂÉ«ÇéӰƬ Services

×îÐÂÉ«ÇéӰƬ 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, ×îÐÂÉ«ÇéӰƬ’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, ×îÐÂÉ«ÇéӰƬ 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

• Largest GMP capacity for capsule spray-dried and carrier-based inhaled powders
• 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 with potent filling capacity of up to 100 million capsules annually
• Capsule filling lines using drum dosing technology with in-line AMV (advanced mass verification) sensor technology
• 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

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PARTNERSHIP WITH TFF PHARMACEUTICALS

×îÐÂÉ«ÇéӰƬ and TFF Pharmaceuticals have a collaboration agreement focused on the generation, testing and manufacture of dry powder formulations for a range of compounds through the application of TFF Pharmaceuticals patented Thin Film Freezing (TFF) technology. To learn more about the partnership and TFF technology, click here.