SAFC expands US high-potency pharma facility

29 August 2007 23:21  [Source: ICIS news]

NEW YORK (ICIS news)--Sigma-Aldrich Fine Chemicals (SAFC) will invest $4.5m (€3.3m) to expand its high-potency active pharmaceutical ingredient (HPAPI) Wisconsin facility in Madison, the company said on Wednesday.

Commissioning was expected in early 2008, company officials said on Wednesday.

The move will boost cGMP (good manufacturing practices) pilot plant and kilo lab capacity and complement the new XRPD (X-ray Powder Diffraction) analytical equipment for advanced solid-form testing.

Two 400-litre reactors and two 100-litre portable jacketed reactors are to be added to a 1,200 square-foot dedicated, large-scale GMP kilo lab. The addition will enable larger-scale chromatography for process purification, catering to future business requirements.

For solid-form testing and analysis, SAFC Pharma has installed and qualified a Bruker D8 Advance X-ray Diffractometer in a new dedicated analytical laboratory, providing US customers with on-site cGMP and XRPD analysis of potent compounds.

Data analysis and evaluation are to be performed at SAFC Pharmorphix in the UK, which SAFC acquired in mid 2006. Pharmorphix, which specialises in solid-form research, is completing its own multiphase, $1.2m expansion programme.

"As regulatory requirements align with the increasing complexity of drugs, solid-form testing, analysis and optimization are becoming key elements in the drug development process,” said Frank Wicks, SAFC president.

($1.00 = €0.73)


By: Clay Boswell
+1 713 525 2653



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