Catalent

	Modern drugs are becoming more complex and often bring bioavailability and delivery challenges to formulation scientists. By tackling these challenges earlier in the process, and selecting an optimal dosage form at the clinical development stage, costly and time-consuming steps can be avoided later in development, and programmes can be accelerated through the clinic and on towards commercialisation.

	Catalent has a broad range of experience and expertise in early phase development, which has seen the company support over 500 investigational new drug (IND) applications. From its facility in San Diego, Catalent supports early phase small molecule development, while its OptiForm® Solution Suite integrates tools and services to deliver relevant data and an optimised development programme; providing an efficient and seamless path from late-stage discovery to phase I clinical trials.

	Designed to make it easier and faster for small and mid-sized innovators to develop better treatments, OptiForm Solution Suite includes a comprehensive range of candidate screening tools, Absorption, Distribution, Metabolism and Excretion (ADME) considerations, and in silico Drug Metabolism and Pharmacokinetics (DMPK) modelling, as well as additional bioavailability enhancing tools to provide materials for cGLP toxicological studies, and on to first-in-human studies.

	Catalent. More products. Better treatments. Reliably supplied.

Articles

Catalent partners with innovators to accelerate programmes through the early phases of development, overcome a molecule’s solubility and bioavailability challenges, and increase its likelihood of success in the clinic.

Early drug formulation and development

Strategies for Building a Flexible Clinical Supply Chain to Meet Modern Challenges

	The acquisition and integration of Cook Pharmica LLC’s business and facility in Bloomington, Indiana, into Catalent’s global biologics network allow its clients to benefit from end-to-end solutions in biologic drug development.

	The capabilities of the Bloomington site, which include clinical and commercial biomanufacturing capacity as well as extensive expertise in sterile formulation and fill/finish across liquid and lyophilized vials, prefilled syringes, and cartridges, complement Catalent’s biologics expertise to provide a single, integrated partner supporting a wide range of clinical and commercial needs.

	Catalent Biologics’ network includes a state-of-the-art development and biomanufacturing facility in Madison, Wisconsin; fill-finish services in Brussels, Belgium and Limoges, France; SMARTag

 antibody-drug conjugation technology in Emeryville, California; and a network of biologics analytical locations.

	Investment and expansion has recently been undertaken at the Madison facility to accommodate two new, 2,000 liter single-use bioreactor systems. This allows the site to support late-phase clinical and commercial production of up to 4,000-liter batches, and analytical and process development laboratories at the site have also been expanded to meet the greater capacity and capabilities.

The acquisition and integration of Cook Pharmica LLC’s business and facility into Catalent’s global biologics network facilities allow its clients to benefit from end-to-end solutions in biologic drug development.

End-to-end Biologics Development Solutions

	Catalent has the broadest drug development toolkit, offering clients multiple technologies to enhance the bioavailability and solubility of drugs during formulation.

	Micronisation is a proven, dependable and versatile method to achieve high quality particle size reduction to assist in API and formulation optimisation. Catalent Micron Technologies is a global leader in particle size reduction services, delivering high quality micronisation, milling, and analytical services. Its full range of capabilities includes:

	   •   Development through to commercial scale
	   •   Micronisation (jet mill)
	   •   Mechanical milling (hammer mill, pin mill)
	   •   Cryogenic milling
	   •   Controlled handling of potent and cytotoxic compounds
	   •   Comprehensive supporting analytical services

	Spray drying can also assist in overcoming formulation and development challenges, and from its facility in San Diego, Catalent offers this service from early phase development through to clinical manufacturing scale. With over 75 years’ experience in spray drying and amorphous dispersion technology, the Pharmatek SD spray drying team can fully characterise an API and associated formulations throughout feasibility, development, and commercialisation, to provide a robust data package in support of regulatory filings.

	The Pharmatek SD spray drying technology offered by Catalent is integrated into its extended OptiForm Solution Suite platform, which allows drug developers to gain an insight into accelerating programmes from late-stage discovery to phase I trials.

Technologies for bioavailability and solubility enhancement

	Catalent has a broad range of experience and expertise in early phase development, which has seen the company support over 500 INDs. From its facility in San Diego, Catalent supports early phase small molecule development, while its OptiForm® Solution Suite integrates tools and services to deliver relevant data and an optimised development programme; providing an efficient and seamless path from late-stage discovery to phase I clinical trials.

	Designed to make it easier and faster for small and mid-sized innovators to develop better treatments, OptiForm Solution Suite includes a comprehensive range of candidate screening tools, ADME considerations, and 

 DMPK modelling, as well as additional bioavailability enhancing tools to provide materials for cGLP toxicological studies, and on to first-in-human studies.

Catalent partners with innovators to accelerate programmes through the early phases of development, overcome a molecule’s solubility and bioavailability challenges, and increase its likelihood of success in the clinic.
