SAFC ANNOUNCES COMPLETION OF FIRST PROJECTS AT NEW $30 MILLION HIGH POTENCY API FACILITY VERONA, WI
SAFC reports that it has seen strong market interest in its recently opened $30 million large scale High Potency (HP) facility in Verona, Wisconsin and has already completed a number of projects at the newly-validated site. Since initiating GMP manufacturing in June 2010, projects have been completed for a variety of customers, including major pharmaceutical companies, over a range of applications including oncology, infectious disease and renal disease.
Designed to significantly increase SAFC’s capacity to produce commercial scale HPAPIs, the 51,000 sq. ft. Verona expansion complements SAFC’s existing 63,000 sq. ft. HPAPI site in Madison WI, and houses commercial-scale reactors capable of producing batch sizes up to 4,000 liters, up to 10 times greater than the capacity at Madison. Constructed specifically to support pharmaceutical manufacturers with their late phase and commercial HPAPI needs, the Verona plant features the same state-of-the-art facility design and containment engineering as the Safebridge® certified Madison Facility, but at a commercial scale.
“We have seen great interest in the Verona site, with many major pharma companies visiting to assess and audit the facility,” comments Dave Bormett, SAFC Director of Operations at both Wisconsin sites. “The range of projects that we have successfully completed to date is an indication of the growing significance of High Potency technology in clinical pharmacology and oncology, and a reflection of SAFC’s aggressive program of investing in key growth areas. With the High Potency market continuing to experience double-digit growth, SAFC is ideally placed to serve the market for the large-scale commercial production of HPAPIs.”
Designed to maximize efficiencies and safe handling in high potency development and to adhere to Category IV standards—the highest guideline for HPAPI handling and containment—the facility includes a 200-liter mini-processing plant and two large-scale cGMP manufacturing suites. Specially designed quality control laboratories, warehouse and office space, plus expansion space, are also featured in the building.