Catalent

Articles

Investing in the Future of Biologics and Advanced Cell and Gene Therapies

	With 85 years’ experience serving the pharmaceutical industry, Catalent is the leading global provider of advanced drug delivery technologies and development solutions for drugs, biologics, gene therapies, and consumer health products.

	From its three early-phase drug development centres of excellence in Nottingham, UK, Somerset, New Jersey, and San Diego, California, and its network of manufacturing facilities, Catalent offers its partners end-to-end solutions, encompassing early drug product formulation and dose form design, through to clinical supply services, commercial-scale manufacturing and lifecycle management.

	For early development, these solutions include analytical, pre-formulation and formulation technologies, and Catalent offers the most comprehensive bioavailability enhancing technology toolkit including lipid formulation, spray drying and hot melt extrusion. Its experience sees Catalent support the development and launch of over 100 new products every year.

	By adapting for each molecule’s unique characteristics and challenges, Catalent uses its experience and a wide range of tools and technologies to create dose forms that benefit patients.

	Catalent’s multi-award-winning OptiForm

 Solution Suite platform can assist in the development of innovative dose forms that can improve a drug’s clinical efficacy and commercial success. OptiForm Solution Suite is fast, flexible and fact-based, combining the broadest selection of enabling technologies to ensure the right decisions are made at each stage of development.

With global development and manufacturing sites, Catalent combines its formulation and bioavailability enhancement experience, along with delivery technologies to support the launch of more than 100 new products every year.

Bioavailability and Development Toolkit

	Catalent has a broad range of experience and expertise in product development, which sees the company support the development and launch of around 200 new products every year.

	Leveraging its early-phase development centers of excellence in the U.K. and U.S., and its global network of manufacturing sites, Catalent offers its partners end-to-end solutions for oral dose development.

	By adapting for each molecule’s unique characteristics and challenges, Catalent uses its formulation and development experience, and a wide range of technologies to create dose forms that can benefit drug developers, and help to improve convenience and patient compliance, reducing patients’ pill burden. These dose forms include:

 providing optimal drug release profiles through targeted delivery, modified release, coated and fixed dose combinations. Innovations including 

 allow oral delivery of macromolecules, while 

 technology produces smaller, spherical capsules.

 offer formulators the option of higher fill temperatures.

- a unique, freeze-dried oral solid dosage form that disperses almost instantly in the mouth. The new 

 technology provides effective taste masking and increased drug loading for a wider range of active ingredients.

 technology for the development of easy-to-take doses in stick packs.

Catalent offers its partners a wide range of innovative oral dose technologies that can benefit drug developers, and help to improve convenience and patient compliance, while reducing pill burden, which is especially important for vulnerable patient populations.

Patient-Centric Dose Forms

	Catalent has a broad range of experience and expertise in early-phase development, which sees the company support the introduction of more than 150 new products to market every year. From its three early-phase drug development centres of excellence in Nottingham, UK, Somerset, New Jersey, and San Diego, California, Catalent offers partners its formulation and development experience, and a wide range of tools and technologies to create innovative, intelligent dose forms to overcome each molecule’s individual challenges, while making better products for patients.

 Solution Suite platform can assist in the development of oral dose forms that can improve a drug’s clinical efficacy and commercial success. OptiForm Solution Suite is fast, flexible and fact-based, combining the broadest selection of enabling technologies to ensure the right decisions are made at each stage of development.

	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 

 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 Pharma Solutions offers its partners end-to-end solutions, from early drug product development, formulation and drug delivery technologies, to manufacturing and global clinical supply services.

Intelligent Dose Design

	To match the growing demand for biopharmaceutical development and manufacturing, Catalent Biologics has invested extensively in its network to create a comprehensive end-to-end offering for customers that includes cell line development, analytical testing, clinical and commercial biomanufacturing, antibody-drug conjugate (ADC) development, fill-finish, and clinical supply services.

	The acquisition and integration of Cook Pharmica, LLC’s Bloomington, Indiana facility into Catalent Biologics’ network has strengthened the company’s position as a leader in clinical and commercial-scale biomanufacturing and finished product supply. The acquisition adds expertise in fill/finish liquid and lyophilised vials, prefilled syringes, and cartridges, secondary packaging, including auto-injectors and safety devices, and 2,500 litres of biomanufacturing capacity.

	In addition to the Bloomington site, Catalent Biologics’ network includes a state-of-the-art development and manufacturing facility in Madison, Wisconsin; SMARTag

 ADC technology in Emeryville, California, prefilled syringe services in Brussels, Belgium; and a network of biologics analytical labs and clinical supply sites around the globe.

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

To match the growing demand for biopharmaceutical development and manufacturing, Catalent Biologics has invested extensively in its network to create a comprehensive end-to-end offering for its customers.