Foster Corp., a medical polymer compounder that dared to go where chemical giants like DuPont wouldn’t, is building a new plant 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).
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’s Delivery Service unit 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.
The primary plastics compounded at the new plant will be:
- Bioresorbable Polymers – PLA, polyglycolic acid (PGA)
- Structural Polymers – polyethylene, PEEK
- Drug-Delivery Polymers – ethylene-vinyl acetate (EVA), thermoplastic polyurethane, polyvinylpyrrolidone (PVP), biaxially oriented polyethylene.
“We are one of the few companies dedicated to hot melt extrusion 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,” says 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 was founded in 1989 by Larry Acquarulo after big chemical companies left the medical implant business due to fears of litigation triggered by silicon implant issues. The landscape has changed slightly in the last 10 years as companies like Solvay have jumped into the medical implant business with new, specialty grades. Another major player is Victrex. Companies like Dow and DuPont still avoid the implant market, leaving significant opportunities for entrepreneurial compounding companies.