Regulatory Quotient Sciences expands early-phase formulation facility

     Quotient Sciences, a drug development services organisation, has announced a significant expansion to its operations in the US with the opening of a state-of-the-art, 45,000 ft2 facility, located in Garnet Valley, Pa.

The $15 million investment will create a centre for early-phase formulation development and clinical trial manufacturing.

The Garnet Valley site will focus on developing small molecule oral drug products, supporting development programmes from the preclinical stage through to clinical proof-of-concept.

While scale-up to late-phase manufacturing and commercial product supply will continue at Quotient’s nearby Chelsea Parkway facility.

“Our new facility was built in response to increasing customer demand for our early-phase formulation development and clinical trial manufacturing services,” said Dr Mark Egerton, CEO of Quotient Sciences.

“The site was specifically designed to optimize our ability to work with highly potent and poorly soluble molecules that dominate the industry pipeline.”

“The facility also increases our capacity to provide integrated translational pharmaceutics programs in the US, which deliver substantial benefits to customers including cost savings and reduced timelines to achieve proof-of-concept,” Egerton added.

According to Quotient the expanded formulation development, analytical and manufacturing capabilities will enable biotech and pharmaceutical companies to access translational pharmaceutics programmes working under an investigational new drug (IND) application. And the approach will integrate real-time adaptive manufacturing and clinical research.

Drug products manufactured at the Garnet Valley facility can be rapidly supplied into global patient trials and clinical pharmacology units, using tailored batch sizes and flexible dose adjustments.

Quotient has comprehensive drug product expertise spanning all dosage forms, from liquids to solids, immediate-release to modified-release and solubilisation technologies including spray-dried dispersions, micronised and lipidic formulations.

The new facility is also designed to handle potent and non-potent products, with six high-potency GMP manufacturing suites. A further expansion of Quotient’s formulation and manufacturing operations will be announced in the coming months.