Regional Sites Contact Us ORAL DOSE BIOLOGICS SPECIALTY CLINICAL SUPPLY CONSUMER EXPERT CONTENT LOCATIONS ABOUT US CAREERS Home » Specialty » Inhalation » Dry Powder Inhalers Dry Powder Inhalers FROM DEVELOPMENT TO FULL COMMERCIAL-SCALE MANUFACTURE AND PACKAGING OVERVIEW Catalent Benefits Catalent Services 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. Back to top 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 Back to top 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 RELATED TOPICS Inhalation Development & Analytical Metered Dose Inhalers Nasal Sprays Regulatory Support Services Small Molecule Analytical Services EXPERT CONTENT Article: Quality by Design for Inhalation Product Development Article: Deep Breaths and Dry Power Contact Us Expert Content Subscribe Investors Careers Contact Us Site Map Follow Us. Share Us. By using this website you understand and accept that Catalent tracks your website activities to be able to offer you a more tailored response or information to meet your requirements, and that your personal data will be held in accordance with our Privacy Policy | Privacy Shield Statement | Cookies Settings. Copyright 2021, Catalent, Inc - All Rights Reserved Terms Modern Slavery Statement This Website Uses Cookies By using this website you understand and accept that Catalent tracks your website activities to be able to offer you a more tailored response or information to meet your requirements, and that your personal data will be held in accordance with our Privacy Policy. Accept All Cookies Cookies Settings