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The company has expanded its operations in the United States with the opening of a new 45,000-ft2, early-phase formulation and manufacturing facility located in Garnet Valley, PA.
Quotient Sciences, a drug development services organization, has expanded its operations in the United States with the opening of a state-of-the-art, 45,000-ft2 facility located in Garnet Valley, PA, near Philadelphia.
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. The new facility is also designed to handle both potent and non-potent products with six high-potency GMP manufacturing suites.
The company reports that 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 Mark Egerton, PhD, CEO of Quotient Sciences, in a company press release. “The site was specifically designed to optimize our ability to work with highly potent and poorly soluble molecules that dominate the industry pipeline.”
The expanded formulation development, analytical, and manufacturing capabilities enable biotech and pharmaceutical companies to access the company’s Translational Pharmaceutics programs working under an investigational new drug (IND) application. The company reports that 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, according to the company.
Additionally, the company will announce further expansion of its formulation and manufacturing operations in the coming months following this press statement.
Source: Quotient Sciences