Foster Delivery Science to Build New Facility; Supports Increased Demand
Foster Delivery Science has recently broken ground on a new facility to support increased demand for manufacturing drug delivery and implant polymer blends. The facility is expected to be completed by May 1, 2015, at which time, it will be registered with the Food and Drug Administration (FDA) to allow for processing APIs.
Foster’s new 32,000-sq-ft facility will be dedicated to HME processing of highly regulated materials and operate according to the cGMP regulations designated by the FDA. These materials are used for improving bioavailability and release rates of oral dose pharmaceuticals, as well as local delivery of APIs in implantable devices. Foster will offer custom drug/polymer blends in powder form for tablet pressing, or extruded into rods, film, or fiber for a wide range of drug delivery applications.
The new facility will include a 1,200-sq-ft ISO Class 7 clean room for processing materials and a 3,500-sq-ft cGMP warehouse for storage of APIs, raw materials, intermediates, and finished products. A comprehensive quality control lab will provide in-house material characterization, including microscopy, thermal analysis, spectroscopy, chromatography, and non-sink dissolution testing.
“We are one of the few companies dedicated to HME processing of APIs. Our success in formulation development, process development, and manufacturing of custom drug/polymer blends has exceeded our expectations and currently available space,” said Tony Listro, Managing Director of Foster Delivery Science. “The new facility will allow us to increase our services in manufacturing of clinical supplies and larger production volumes.”
Foster Delivery Science specializes in hot melt extrusion of drugs and polymer for pharmaceutical and combination drug-device applications. Foster Delivery Science is a wholly owned business unit of Foster Corporation, a leader in custom biomedical polymers for minimally invasive devices, implants, combination products, and pharmaceutical drug delivery. For more information, please visit www.deliveryscience.com.
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