Foster Delivery Science, a business unit of Foster Corporation and hot melt extrusion (HME) specialist for pharmaceutical and medical device applications, will build a new facility to deal with demand for manufacturing drug delivery and implant polymer blends. The facility is expected to be completed by the beginning of May 2015. At this point it will be registered with the Food and Drug Administration (FDA) to allow for processing active pharmaceutical ingredients (APIs).
Foster’s new 32,000 square foot facility will be dedicated to HME processing of highly regulated materials and operate according to the controlled Good Manufacturing Practice (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 fibre for a range of drug delivery applications.
The new facility will include an ISO Class 7 clean room for processing materials and a cGMP warehouse for storage of APIs, raw materials, intermediates and finished products. A comprehensive quality control lab will provide in-house material characterisation, 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.”