Sigma-Aldrich opens large-scale high-potency unit
pharmafile | April 7, 2010 | News story | Manufacturing and Production | Sigma-Aldrich
Sigma-Aldrich has increased its high-potency active pharmaceutical ingredient (HPAPI) production capacity with the opening of a newly-expanded facility that is due to start production later this month.
Sigma-Aldrich’s SAFC Pharma division has invested $30 million into the 51,000 sq. ft. expansion of its manufacturing site in Verona, Wisconsin, which was first announced towards the end of 2008.
The site lies adjacent to SAFC’s existing 63,000 sq. ft. facility in Madison and is designed to meet high-volume production demands for HPAPIs, such as Phase III clinical trial materials and commercial-scale manufacturing.
The expansion includes facility will meet containment Category IV standards, the highest guideline for HPAPI handling and containment, and will include development laboratories, a 150-litre mini-processing plant, and two large-scale cGMP manufacturing suites capable of producing HPAPI batch sizes up to 4,000 litres, ten times greater than the capacity at Madison.
SAFC has invested upwards of $75 million in HAPI capacity in the last couple of years in order to meet expanding demand for oncology products, including antibody drug conjugates (ADCs), as well as other therapeutic categories.
Since 2008 it has also commissioned a new suite at its St. Louis facility in Missouri to make HPAPI conjugates, built a pilot-scale lab at Madison and invested $29 million to expand bacterial and fungal fermentation derived HPAPI capacity at its site in Jerusalem, Israel.
Market research firm GBI Research estimates in its most recent report on the sector that the global HPAPI market will grow at a compound annual rate of 8.4% between 2009 to 2015, outstripping growth in other API categories.
Gilles Cottier, SAFC president, said the move “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.”
Meanwhile, SAFC has been investing in other specialty manufacturing sectors to insulate its business from competition from cheaper competitors operating in Asia. For example, last October it spent $12 million expanding a facility to make viral and other biotechnology products at its site in Carlsbad, California.
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