SAFC Pharma plans further major expansion of Madison site
SAFC Pharma, a focus area within SAFC, a member of the Sigma-Aldrich Group is to spend US$30m (Euro 21m) on increasing the production capacity for commercial scale High Potency Active Pharmaceutical Ingredients (HPAPIs) at its facility in Madison, Wisconsin.
SAFC Pharma, a focus area within SAFC, a member of the Sigma-Aldrich Group is to spend US$30m (Euro 21m) on increasing the production capacity for commercial scale High Potency Active Pharmaceutical Ingredients (HPAPIs) at its facility in Madison, Wisconsin.
The investment includes the purchase of 15 acres of green space in Verona, near its existing HPAPI production site, where the company will build a new 45,000ft2 manufacturing facility that will house commercial scale reactors capable of producing HPAPI batch sizes up to 4,000 litres. Construction of the new plant is expected to be complete by the end of 2009.
The design of the new facility will maximise efficiencies and safe handling in high potency development and adhere to Category IV standards, the highest guideline for HPAPI handling and containment. The site will seek Safebridge certification upon its completion.
The facility will include state-of-the-art development laboratories, a 150 litre mini-processing plant and two large-scale cGMP manufacturing suites with reactors up to 4,000 litres. Specially designed quality control laboratories, a potent compound packaging area and warehouse and office space, plus expansion space, will also be featured in the building.
"Currently, there is minimal manufacturing capacity to support market demand for large-scale HPAPI production," said Dave Feldker, SAFC Pharma vice president of sales and manufacturing, US. "Our new investment at Madison will enable us to continue to meet the increasing demand for HPAPI production and put us at the forefront in manufacturing commercial-scale high potency materials."
This investment brings SAFC's total spend on developing its HPAPI manufacturing capabilities in recent years to more than $75m ( €52.5m). In the last 18 months alone the company has announced a total of $45m ( €31.5m) in HPAPI expansions, including a recently completed $4.5m ( €3.15m) extension of its cGMP pilot plant and kilo-lab capacity.
Operations have now begun at its new biologic-HPAPI conjugation suite in St. Louis, and SAFC Pharma has also invested in a major facility in Jerusalem, Israel, for large-scale production of bacterial and fungal fermentation-derived HPAPIs.