The investment will see the site focus on preclinical to clinical phase IIb formulation, analytical and manufacturing solutions for orally delivered small molecules
Catalent Pharma Solutions, a provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, plans to invest $5 million in the creation of a new drug development center of excellence (CoE) at its Somerset, New Jersey facility and headquarters.
The investment will see the site focus on preclinical to clinical phase IIb formulation, analytical and manufacturing solutions for orally delivered small molecules.
It will also build upon the site’s expertise in the development of modified release formulation, bioavailability solutions, the application of OptiMelt hot melt extrusion (HME) technology and its status as the company’s CoE for handling potent compounds and controlled substances.
"This latest investment in Somerset will significantly strengthen our early development offering with focused formulation expertise and capacity for additional speed and flexibility," said Jonathan Arnold, President of Catalent’s Oral Drug Delivery business unit.
"It is highly complementary to Catalent’s West Coast facility in San Diego, California and further positions Catalent as the strategic partner of choice for the early development of solid oral dose forms."
Catalent’s 265,000 sq. ft headquarters and development center in Somerset has a long track record of successfully developing, launching and manufacturing many oral treatments for leading global innovators.
The site boasts state-of-the-art analytical labs, pilot and clinical scale equipment including HME and fluid bed processing, and significant expertise in coating technologies, capsules, tablets, mini tablets, and multi particulates.
Catalent’s early phase drug development sites are closely connected to Catalent’s Clinical Supply Services network, to optimise the transition from finished dose manufacture to clinical packaging and distribution.
Additionally, the Somerset facility will offer seamless transfers to Catalent’s integrated commercial manufacturing network in: Kansas City, Missouri; Winchester, Kentucky; Swindon, UK; and Schorndorf, Germany, for later stage clinical trials using compatible, scalable equipment.