Drug development services provider Quotient Sciences has opened a 45,000ft² manufacturing facility near Philadelphia, in Garnet Valley, Pennsylvania.
The $15 million investment will create a center of excellence for early-phase formulation development and clinical trial manufacturing.
The Garnet Valley site will focus on developing small molecule oral drug products, supporting development programs from the preclinical stage through to clinical proof-of-concept. Seamless scale-up to late-phase manufacturing and commercial product supply will continue at Quotient’s nearby Chelsea Parkway facility.
Quotient Sciences CEO Mark Egerton 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.”
The expanded formulation development, analytical and manufacturing capabilities enable biotech and pharmaceutical companies to access Translational Pharmaceutics programs working under an investigational new drug (IND) application.
This approach integrates 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 solubilization technologies including spray-dried dispersions, micronized and lipidic formulations.
The new facility is also designed to handle both 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.
Source: Company Press Release.