Catalent

Articles

Transforming IMP into Clinical Supply: An Integrated Approach

With more than 30 years of experience in supporting the development of inhaled products, and full commercial-scale manufacturing capabilities for dry powder inhalers, metered dose inhalers and unit/bi-dose nasal sprays, Catalent offers complete, end-to-end solutions for today’s inhalation dose forms.

Catalent provides formulation feasibility, device selection and clinical supply services, through to commercial filling and packaging, as well as analytical testing, final product characterization and release testing to ensure accurate, consistent drug delivery. 

https://www.catalent.com/specialty/inhalation/


14 Schoolhouse Road Somerset, NJ 08873 USA
Tel. +1.888.765.8846
solutions@catalent.com


With more than 30 years’ experience, Catalent offers end-to-end solutions for multiple inhalation dose forms.

Integrated Inhaled Dose Development

Catalent has more than 25 years’ experience as a global leader in clinical supply services with flexible solutions for small molecules, biologics, and cell and gene therapies, including integrated services to accelerate products from early development to clinic.

Catalent offers customers a full range of services including clinical supply management, comprehensive packaging solutions, comparator sourcing, cold chain storage, and global distribution, as well as specialised supply chain services including FlexDirect

 direct-to-patient services and FastChain

With its eight GMP clinical packaging facilities, as well as two more opening soon, and over 50 strategically located global depots providing local and regional options for storage, distribution, and clinical returns management, Catalent has supported thousands of studies of all sizes and complexities in more than 80 countries.

To accommodate the need for greater flexibility in clinical trials, Catalent offers FlexDirect direct-to-patient supply solutions, enabling clinical supplies to be sent directly to patients’ homes. By reducing or eliminating the need for in-person clinical site visits and removing a key barrier for trial participation, sponsors can expand their geographic recruitment area, especially for rare diseases, potentially improving patient recruitment and retention.

To find out more about Catalent’s integrated services, visit 

Catalent is a global leader in clinical supply services with flexible solutions for small molecules, biologics, and cell and gene therapies, including integrated services to accelerate products to the clinic.

Integrated and Flexible Clinical Supply Solutions

Catalent’s OneXpress is a single, integrated solution that provides the fastest pathway from clinical development to commercial manufacturing. By taking a proactive approach and assessing production considerations early in development, the solution can help reduce a programme’s risk and increase chances of success by working in parallel to address potential roadblocks and ensure robust processes from clinic to launch.

Using Catalent’s integrated global network of facilities, and streamlined programme management, the OneXpress solution combines the expertise at Catalent’s early-phase drug development centres of excellence in Nottingham, U.K., Somerset, New Jersey, and San Diego in the U.S., with the proven track-record of Catalent’s oral solid dose commercial manufacturing facilities.

Overseen by a dedicated programme manager from start to finish, OneXpress combines phase-appropriate technologies and proven expertise, with scalable end-to-end capabilities throughout an extensive supply network, to achieve optimal accelerated manufacturing solutions at every stage.

Catalent’s OneXpress™ solution combines phase-appropriate scale and technologies with expertise across diverse dose forms to simplify development and accelerate a programme towards commercialisation.