SAFC Inaugurates New High Potency API Facility In Madison
SAFC, a member of the Sigma-Aldrich Group, has opened a $30m expansion to its Madison Manufacturing facility in Verona, Wisconsin, to increase the capacity to produce commercial scale high potency active pharmaceutical ingredients (HPAPIs).
SAFC said that the new facility complements its existing 63,000 sq ft HPAPI site in Madison and houses commercial scale reactors capable of producing HPAPI batch sizes up to 4,000 liters, which is up to 10 times greater than the capacity of the Madison site.
Constructed specifically to support pharmaceutical manufacturers with their Phase III and commercial HPAPI needs, the Verona plant features the same design and containment engineering as the Safebridge certified Madison Facility on a larger scale.
The site is designed to maximise 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 development laboratories, a 150-liter mini-processing plant and two large-scale cGMP manufacturing suites. Specially designed quality control laboratories, a potent compound packaging area and warehouse and office space, plus expansion space, are also featured in the building.
Gilles Cottier, president of SAFC, said: "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.”