Process Development and Drug Manufacturing Facility
Ash Stevens’ Process Development and Drug Manufacturing Facility is located in Riverview, Michigan. The 30,000 sq. ft. facility houses eight chemical drug development and production laboratories, three full-scale production areas, as well as three analytical laboratories for quality control. Projects at this facility typically involve:
* Process development
* Material manufacture for toxicology studies
* cGMP manufacture of clinical trial materials
* Post-approval commercial production of drug product
Major production equipment include glass-lined batch vessels (up to 500 gallons), hydrogenation and other pressure vessels, centrifugal, Nutsche and contained filter-dryer equipment and vacuum and convection tray drying ovens. Ash Stevens also has barrier isolation systems for the manufacture of highly potent or air-sensitive compounds.
Major quality control equipment includes High Performance Liquid Chromatography (HPLC-equipped with the following detectors: VWD, DAD, RI, and MS), Gas Chromatography (GC), high field NMR , UV/Vis and FTIR spectrophotometers, Total Organic Carbon Analyzer, and Karl Fischer titrators. Stability chambers are maintained at ICH accelerated, intermediate, room temperature, refrigerator and freezer conditions.