ProMed Pharma recently celebrated their first anniversary of the opening of its New Product Development and Analytical Testing facility in Maple Grove, MN.
The facility currently includes two state-of-the art Class 7 clean rooms with dedicated air handling, gowning areas and a 2,500 sq/ft analytical laboratory. The first suite is approximately 1,800 sq/ft and dedicated to supporting customer-funded early-stage development and feasibility projects using both injection molding and hot melt extrusion processes for producing sustain release products. The second suite presently houses late-stage clinical and commercial development activities using highly potent APIs such as hormones.
The analytical laboratory presently houses more than half a dozen HPLCs and UPLCs for analytical method development and clinical lot release testing of complex dosage forms including ophthalmic implants, IUDs and vaginal rings. Incubator shakers, USP II (paddle), and USP VII (small volume reciprocating cylinder) are available in addition to laser microscopy, differential scanning calorimetry, FTIR, UV-Vis, Karl Fisher, GC, and GPC.
Dr. James Arps, Director of Business Development at ProMed, noted “the past year has marked a significant expansion in formulation, clinical manufacturing, and test capabilities for ProMed Pharma, with more than a dozen projects in clinical stage development we are well positioned to support our partners as they prepare for commercial launch.” Significant expansion capacity exists both at the Wedgwood Ave site as well as the main Operations facility located in Plymouth, MN.
About ProMed Pharma:
ProMed Pharma specializes in the molding and extrusion of drug-loaded silicones, thermoplastics, and bioresorbable materials, leveraging this expertise to manufacture long-term implants and combination devices under cGMP. Working with both established and early-stage companies, we utilize robust manufacturing processes for controlled release of APIs utilizing a variety of materials. From clinical trial materials to commercial products, ProMed supports pharmaceutical and medical device companies developing controlled release formulations including subcutaneous, orthopedic, cardiovascular, ophthalmic implants, intravaginal rings, and steroid-eluting combination components. The company has facilities in Plymouth and Maple Grove, Minnesota. Please visit www.promedpharmallc.com for more details.