SAFC has opened the $30m (€22m) expansion of a US production facility, adding HPAPI capacity to meet rising demand for Phase III and commercial manufacturing services.
High potency active pharmaceutical ingredients (HPAPI) are increasingly prevalent in pharmaceutical pipelines and this is driving demand for large-scale manufacturing services.
To meet this demand SAFC has expanded its facility in Madison, Wisconsin, US. The 51,000 sq ft expansion houses commercial scale reactors capable of producing batch sizes up to 4,000 litres, 10 times greater than was previously possible, for large-scale manufacture.
"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", added Gilles Cottier, SAFC President
SAFC’s expansion also includes development laboratories, a 150L mini-processing plant, quality control suites and a potent compound packaging area. These operations are supported by warehouse and office space.
The expansion complements the existing 63,000 sq ft HPAPI facility at the Madison site. Housed at the original facility are eight process development laboratories, eight kilo labs and two pilot plants with capacities of 200L and 800L.
Design and containment engineering used in the original facility, which is certified by Safebridge, has been applied to the expansion on a larger scale. Measures have been taken to maximise efficiencies, ensure safe handling in HPAPI development and adhere to category IV standards.
Expansion of the site will ultimately create 45 to 50 jobs, said Jim Doyle, Wisconsin State Governor. SAFC added that there is room for further expansion at the new facility in Madison.