In keeping with the current trend among contract manufacturing organisations to tap into niche markets, SAFC has started construction of a new facility aimed at meeting the demand for manufacturing of highly potent active pharmaceutical ingredients (APIs).
The recently-renamed division of Sigma-Aldrich has just broken ground on a major expansion at its Madison, Wisconsin, facility. The 38,000 square foot expansion will more than double the size of its existing 23,500 square foot building.
The expansion is being driven by an increase in demand for custom chemical manufacturing services for highly potent APIs, including category III and category IV compounds.
"The expansion further positions us to provide unparalleled service in the high potency API manufacturing market," said Frank Wicks, president of SAFC.
The company made its ambitions in high potency compounds clear in June 2004, when it acquired Tetrionics. At the time, Wicks said: "High potency drugs represent one of the fastest growing segments of the pharmaceutical industry, with roughly 25 per cent of all new drugs under development falling into this category."
One of the factors driving the development of high potency market has been a shift in the average doses of all drugs from around 100mg/day in the 1980s to around 40mg/day now, as companies strive to develop drugs with more specific action and fewer side effects.
Another has been the growth of the market for cytotoxic cancer drugs, although latterly interest in this area has waned as pharmaceutical companies focus instead on developing drugs designed to strike at the underlying molecular mechanisms in cancer.
And while high potency has been held up as a new growth opportunity for CMOs hit by overcapacity in the marketplace, the number of investments in this area have led some industry observers to suggest that competing in this sector may soon become a challenge. In this regard, SAFC can draw on its own history in the high potency sector and the longstanding heritage brought by Tetrionics.
The new two-story addition will include: expanded research and development suites and scale up laboratories; new analytical laboratories and equipment; five new cGMP kilolab manufacturing suites; and increased warehousing and storage space.
The company anticipates the expansion will be complete in early 2006.