Sigma expands Buchs site

Sigma-Aldrich has expanded its development and manufacturing for active pharmaceutical ingredients (APIs) at its cGMP certified production site at Buchs in Switzerland.

The newly opened cGMP kilo lab has been designed for the production of gram-to-several kilogram quantities of APIs and key intermediates for preclinical phase to phase II clinical studies, and further expands Sigma-Aldrich's contract development and manufacturing services to the pharmaceutical industry.

The new kilo lab is based on simulated moving bed (SMB) separation technology and has been designed to address drawbacks of scale-up from benchtop to production that can lead to loss of time and money during the development of a new drug. As a partner, Sigma-Aldrich says, its SMB technology helps biotech and pharmaceutical companies to overcome the problems associated with separation techniques, such as preparative-scale, high-performance liquid chromatography (HPLC).

'The scale-up of APIs from the discovery stage to the production stage invariably involves complex chemistry or route redesign,' comments Dr Andreas Weiler, business manager Europe, organic custom synthesis. 'A project is likely to be more economic if costly development is optimised in early-stage clinical trials.