Frontage Labs has announced plans to expand its chemistry, manufacturing and controls (CMC) facility in Exton, Pennsylvania, US.
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The expansion includes significant incremental capacity to existing services, and will also provide Frontage with additional room for future growth.
The renovation plan involves two phases. Initial enhancements, which include two analytical laboratories and 8000 square feet of office space, will begin in mid-2014, with completion scheduled for the end of September.
The second phase, which includes additional clinical trial manufacturing (CTM) space for solid, semi-solid and sterile products, packaging, labeling and distribution functions, will be implemented at the beginning of 2015. Following the completion of this expansion in mid-2015, Frontage expects to increase its CMC workforce and capacity by more than fifty percent.
"We’re excited that consistent growth over recent years is enabling us to expand capacity and service offerings," said Dongmei Wang, Senior Vice President of CMC Services. "The infrastructure improvements will allow us to meet ever-thriving client demand for product development support, while adding efficiency gains to small scale CTM production and laboratory throughput."
Frontage’s CMC service portfolio includes organic synthesis, formulation development, GMP analytical testing and GMP clinical trial material manufacturing, for all types of drug candidates ranging from novel, early phase projects to generic-equivalent and consumer care medications.
Over the last ten years, Frontage developed oral solid, semi-solid, liquid and sterile dosage forms that have been evaluated in clinical research programs and commercialized in the US, EU and Asian markets by its clients.
Frontage helps biopharmaceutical organizations advance their research and development efforts with full service offerings- including bioanalysis, preclinical and clinical studies, analytical testing and product development support- spanning discovery stages through late-stage clinical trials.
The company also provides product development, bioequivalence and analytical services to generic and consumer health pharmaceutical companies to support Abbreviated NDA and 505.b.2 application submissions.