SAFC Opens Second High-Potency API Facility in Madison
$30 million construction will support Phase III and commercial needs, with 10 times increased capacity.
SAFC has opened a $30 million, 51,000 sq. ft. facility in Verona, Wisconsin that increases its capacity to produce commercial-scale high-potency active pharmaceutical ingredients (HPAPIs). The new plant complements SAFC's existing 63,000 sq. ft. HPAPI site in Madison, WI.
The Verona facility was built specifically to support pharmaceutical manufacturers with their Phase III and commercial HPAPI needs. It houses commercial-scale reactors capable of producing HPAPI batch sizes up to 4,000 liters, 10 times greater than the capacity at the smaller Madison site. The facility includes quality-control development laboratories, a 150-liter mini-processing plant, two large-scale cGMP manufacturing suites, a potent compound-packaging area, as well as a warehouse and office space with the ability to further expand.
“With the high-potency market continuing to experience double-digit growth and ongoing significant advances in clinical pharmacology and oncology, there is a significant need for the large-scale production of HPAPIs,” points out Gilles Cottier, SAFC president. “This new facility represents a significant step toward addressing that market demand and supports SAFC's desire to maintain a leadership position in commercial-scale high-potency manufacture.”
The Verona plant also features the same design and containment engineering as the Safebridge®-certified Madison facility but on a larger scale, according to SAFC. It is 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.
SAFC is the custom manufacturing and services business unit within Sigma-Aldrich that focuses on high-purity inorganics for high-technology applications, cell culture products and services for biopharmaceutical manufacturing, biochemical production, and the manufacturing of complex, multistep organic synthesis of APIs and key intermediates.