Catalent Pharma Solutions, the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products, has announced the expansion of potent handling and manufacturing capabilities at its Somerset (NJ, USA) facility. Together with recently announced investments in high potency clinical packaging, as well as the acquisition of Micron Technologies, this investment further expands Catalent’s extensive suite of solutions for high potency compounds, from optimization through clinical and commercial manufacturing of final dose form.
Catalent has completed the expansion of facility and engineering controls for its high potency tableting and OptiMelt Hot Melt Extrusion operations in Somerset to supplement existing potent capabilities in oral solid and Zydis Fast Dissolve manufacturing. The company is now investing in additional potent containment for large scale blending, fluid bed processing, and high shear granulation, which will come online throughout the first half of 2015.
The expansion creates a manufacturing Center of Excellence for potent handling across Catalent’s portfolio of oral solid manufacturing solutions, which includes hot melt extrusion, high-shear and wet granulation processing, solvent-based capability, extrusion/spheronization, fluid-bed processing, Wurster coating, and compression and encapsulation.
The Somerset facility is capable of handling SafeBridge Category 3 and 4, with SafeBridge certification expected in July of 2015 (SafeBridge is a registered trademark of SafeBridge Consultants, Inc.).
“With the growing pipeline for oncology and other highly potent compounds, industry demand for development and manufacture is increasing,” commented Jonathan Arnold, Vice President and General Manager of Catalent’s Advanced Delivery Technologies business. “Catalent has extensive experience in potent compound handling, now providing analytical, development, manufacturing and packaging services for over 300 Category 3 and 4 potency compounds across our global network. Our continued investment demonstrates our commitment to providing comprehensive solutions across the entire drug development cycle.”
Catalent’s global potent manufacturing capability spans both oral and injectable dose forms, including a full suite of development and manufacturing services for traditional oral solids, Micron Particle Size Engineering, RP Scherer Softgel Technologies, Zydis Fast Dissolve, OptiMelt Hot Melt Extrusion, Blow-Fill-Seal, and ADVASEPT glass-free injectable technology (www.catalent.com/potent).