Sep 17 2014
Foster Delivery Science, a leader in hot melt extrusion (HME) for pharmaceutical and medical device applications, has 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 active pharmaceutical ingredients (APIs).
Foster’s new 32,000 square foot (2,973 sq. meters) 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 fiber for a wide range of drug delivery applications.
The new facility will include a 1,200 square foot (111 sq. meters) ISO Class 7 clean room for processing materials and a 3,500 square foot (325 sq. meters) 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.”
For more information, please visit www.deliveryscience.com.