Quotient Sciences, a UK-based drug development services provider, has expanded its operations in the US by opening an early phase formulation and manufacturing plant in Garnet Valley near Philadelphia.
The new facility is of 45,000sft phase formulation and manufacturing plant has been built with an investment of $15 million. Quotient Sciences said that the expansion will facilitate phase formulation development and clinical trial manufacturing.
The new facility of the drug development services provider at Garnet Valley will focus on the development of small molecule oral drug products and will support development programs from preclinical stage to clinical proof-of-concept.
Quotient Sciences said that seamless scale-up to late-phase manufacturing and commercial product supply will continue to be done at its nearby located Chelsea Parkway facility.
Commenting on the new early phase formulation and manufacturing plant in Garnet Valley, Mark Egerton – CEO of Quotient Sciences, said: “Our new facility was built in response to increasing customer demand for our early-phase formulation development and clinical trial manufacturing services.
“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 U.S., which deliver substantial benefits to customers including cost savings and reduced timelines to achieve proof-of-concept”.
Quotient Sciences said that following the expansion of its formulation development, analytical and manufacturing capabilities, biotech and pharmaceutical companies can get access to Translational Pharmaceutics programs working under an investigational new drug application (IND).
According to Quotient Sciences, this method integrates real-time adaptive manufacturing research as well as clinical research. The drug products manufactured at the early phase formulation and manufacturing plant in Garnet Valley can be quickly delivered to patient trials and clinical pharmacology units across the world by using customized batch sizes and flexible dose adjustments.
Quotient Sciences claims to have comprehensive drug product expertise, covering all dosage forms like liquids to solids, immediate-release to modified-release along with solubilization technologies such as spray dried dispersions, micronized and lipidic formulations.
The new early phase formulation and manufacturing plant in Garnet Valley is also capable of handling potent as well as non-potent products, with half-a-dozen GMP manufacturing suites.
Quotient Sciences expects to make announcements regarding further expansion of its formulation and manufacturing operations in the next few months.