US fine chemical company Sigma-Aldrich said this morning that subsidiary SAFC Pharma has kicked off a $30m expansion plan for its active high-potency pharmaceutical ingredient (API) manufacturing facility in Madison, Wisconsin.
The aim of the investment programme is to expand further SAFC Pharma’s activities in high-potency APIs, a growth area in the pharmaceutical sector.
The pharmaceutical industry is turning more and more to highly potent active pharmaceutical ingredients (HPAPIs), creating opportunities for drug producers and contract manufacturers alike.
For manufacturers the appeal of high-potency is in its high barrier to entry and highly-specialised requirements, particularly in terms of containment, contamination prevention and operator safety. Manufacturers in the US and Europe have increasingly been moving into specialised areas such as high-potency because, at least for the moment, there is less competition from fast-developing pharmaceutical markets such as Asia and eastern Europe.
The scale of the Madison unit is becoming a major advantage.
"Currently, there is minimal manufacturing capacity to support market demand for large-scale HPAPI production," said Dave Feldker, SAFC Pharma’s vice president of sales and manufacturing, US.
SAFC Pharma’s investment programme includes the purchase of 15 acres of green space in Verona, located near its existing HPAPI production site.
The new 45,000 sq. ft. 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 with reactors up to 4,000 litres. It will also house quality control laboratories, a potent compound packaging area and warehouse and office space, and leave room for further expansion.
The company expects to complete the construction of the new plant by year-end 2009, and will ask for review of the unit by SafeBridge Consultants, a group that provides third-party certification in the absence of formal regulatory guidance from the US Food and Drug Administration (FDA).
Cancer drugs, and beyond...
The high-potency API market is being driven by demand in oncology, with cancer drugs showing the most buoyant growth of any therapeutic category in the pharmaceutical industry, according to recent data from IMS Health. Growth in 2007 was around 16 per cent, well ahead of the average of 6 per cent across the pharma sector.
While a large portion of the growth is due to monoclonal antibodies, chemical agents are still the biggest sellers, and increased use of monoclonal antibody-drug conjugates (ADCs) is also driving demand for chemical cytotoxic manufacturing as well. Recognising that, SAFC Pharma started building a high-potency conjugation suite at its API facility in St Louis last year, and this has recently started operations.
Other drugs classed as highly-potent according to their occupational exposure limits include opioids, some hormonal agents and prostaglandins. But the development pipelines are now filling up with drugs which fall under that category. Faced with dwindling R&D productivity, pharmaceutical companies are being driven off the well trodden research track to pursue ever more uncharted targets, and the drugs which tackle them are often highly-potent.
SAFC Pharma has been gradually adding HPAPI capacity for some time, and all told has invested around $75m in the area.
A $4.5m investment in pilot plant and kilo lab capacity was unveiled at the Madison facility last year, and this followed another $12m, 38,000 sq. ft. expansion program that was completed in 2006.
Meanwhile, the company is also expanding in HPAPI production outside the US. Last September it announced a $29m investment programme to expand HPAPI fermentation capacity at the its unit in Jerusalem, Israel, which is due for completion in 2009.