Catalent completes expansion of potent handling and manufacturing capabilities in Somerset, NJ
Adds additional potent containment for large-scale blending, fluid bed processing and high shear granulation
Catalent Pharma Solutions has expanded its potent handling and manufacturing capabilities at its US headquarters in Somerset, NJ.
Together with recently announced investments in high potency clinical packaging, as well as the acquisition of Micron Technologies, this further expands Catalent’s solutions for high potency compounds, from optimisation to clinical and commercial manufacturing of the final dosage form.
Catalent has expanded the 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/spheronisation, 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 this year.
Jonathan Arnold, Vice President and General Manager of Catalent’s Advanced Delivery Technologies business said: 'With the growing pipeline for oncology and other highly potent compounds, industry demand for development and manufacture is increasing.
'Catalent has extensive experience in potent compound handling, now providing analytical, development, manufacturing and packaging services for more than 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.'
