Catalent

	Catalent Pharma Solutions, the leading global provider of advanced drug delivery technologies and development, provides a broad range of inhalation solutions.

	From pre-formulation to commercialisation, Catalent integrates its experience in pre-formulation sciences, formulation development, device evaluation/selection, performance testing, chemistry, manufacturing and control (CMC), and manufacturing to reliably deliver dosage forms including:

	   •   Pressurized metered dose inhalers (pMDIs)
	   •   Dry powder inhaler (DPIs)
	   •   Nasal sprays
	   •   Solutions/suspensions for inhalation.

	The integration of Catalent Micron’s particle size reduction capabilities into the company’s development and formulation portfolio provides unique solutions in micronisation and classification of powders, meeting the tightest specifications required for inhalation products. These include:

	   •   Micronisation (jet mill)
	   •   Mechanical milling (hammer mill, pin mill)
	   •   Cryogenic milling
	   •   Potent and cytotoxic compounds
	   •   Comprehensive analytical services.

	For more than 40 years, Catalent has provided end-to-end solutions from its inhalation manufacturing operations in RTP, North Carolina, and Woodstock, Illinois. The deep expertise in this specialised field, and reliable execution have been successfully applied to all primary inhaled dosage forms to accelerate drug development programmes and bring better treatments to patients worldwide.

Articles

Catalent combines its formulation expertise, manufacturing excellence and particle size reduction technologies to provide a broad range of solutions in the development of inhalation and nasal drug products.

Manufacturing and Formulation Solutions for Inhaled Dose Forms

	Catalent is the leading global provider of advanced drug delivery technologies and development solutions, providing worldwide clinical and commercial supply capabilities for drugs, biologics, and consumer health products. The company has over 80 years’ experience serving the industry, and proven expertise in bringing more customer products to market faster, enhancing product performance, and ensuring reliable product supply.

	Catalent’s solutions include analytical, pre-formulation and formulation, the recent addition of spray dry dispersion specialist Pharmatek, and biologics technologies and manufacture. Catalent now offers the most comprehensive toolkit of bioavailability enhancing technologies and the development of patient centric dose forms.

	Catalent serves thousands of innovators, both established and emerging, in over 80 markets, including 48 of the top 50 pharmaceutical and 41 of the top 50 biotech companies. Its team of over 1,400 talented scientists has supported over half of all new molecular entities approved by the FDA in the past 10 years, and from more than 30 global sites it supplies more than 70 billion units annually, to customers in over 80 countries.

	Whether an innovator is looking for a single, tailored solution, or multiple answers throughout a product’s lifecycle, Catalent can improve the total value of treatments, from discovery to market and beyond.

	Catalent. More products. Better treatments. Reliably supplied.

Dose Form Development

	Catalent combines more than 80 years' manufacturing expertise, superior product quality and reliable supply, with a global network of facilities approved by 35 regulatory agencies, to provide flexible commercial and clinical manufacturing solutions. As a collaborator and innovative solution provider, the company has supported over half of all new molecular entities approved by the FDA in the last ten years.

	Producing over 70 billion doses annually, Catalent provides manufacturing expertise for oral, sterile, biologic and inhaled dose forms for clients around the world. It has proven expertise in technology transfers and product launches, custom suite models, speciality handling (highly potent / DEA licenced compounds), and manufacturing technologies, leveraging its more than 30 global facilities with the capacity to support a wide range of small and large scale manufacturing requirements.

	From a single, tailored solution, or multiple answers throughout a product's lifecycle, Catalent can improve the total value of treatments - from discovery to market.

Flexible Manufacturing Solution

As more drug companies adopt comparative effectiveness studies, drug supply professionals are challenged with sourcing and managing comparator drugs. This ebook examines research from the Tufts Center for the Study of Drug Development, and reviews the pros and cons of the transactional and strategic comparator sourcing models to aid in the development of effective sourcing approaches. Special considerations, and commonly encountered issues in biologics sourcing are discussed. In addition, areas to consider in equivalence testing for comparability are reviewed.