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.
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
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
PARTNERSHIP WITH TFF PHARMACEUTICALS
Catalent 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.