world class expertise to scale your product from the clinic and into the marketplace
Catalent offers flexible manufacturing solutions at scales suitable to reliably supply pre-clinical evaluation studies through to clinical studies and into the marketplace. Our inhalation-manufacturing operations have a track-record of regulatory excellence, and we routinely manufacture pMDIs, DPIs, and nasal formulations for clients around the globe.
Our manufacturing operations include an assortment of automated and semi-automated equipment that supports formulation and filling into a variety of formats/devices (pMDIs, DPIs, nasal sprays, and nebules). We are equipped to safely and effectively manufacture controlled substances and potent compounds, and our facility is equipped with ISO7-classified space and environmental controls to enable unit operations to be performed with appropriately controlled air and, when necessary, at select (e.g., low) humidity set-points.
To compliment our manufacturing operation, we utilize state-of-the-art process-analytical technologies to support process understanding and QbD filing strategies. Utilizing our mature supply-chain, Catalent sources raw materials and components for use in production activities and support their release for use in manufacturing via its industry leading compendial testing services.
- Pre-clinical, clinical, and commercial-scale manufacturing operations.
- Automated and semi-automated filling operations for pMDI, DPI, solutions/suspensions for inhalation, and nasal products.
- Low-humidity environment options to support moisture-sensitive materials.
- Process-analytical technologies.
- Supply-chain and project management services.