Production of large molecule recombinant proteins and small molecule APIs likely to start in October
SAFC has completed the state-of-the-art expansion of its Jerusalem, Israel facility. The additional capacity expands SAFC's contract manufacturing capabilities in large molecule recombinant proteins and small molecule APIs through fermentation, including High Potent APIs (HPAPIs) and secondary metabolites.
The 50,000ft2 cGMP fermentation expansion, which is expected to begin production in October 2010, will focus on niche fermentation of APIs and bulk drugs, producing secondary metabolites (antibiotic-like molecules), cytotoxins and large-molecule proteins. A 30,000ft2 area of the new facility has been designed to be Biosafety Level 2 compliant - enabling manipulation of human pathogens. Capabilities include 1,000 and 4,000-litre tank capacities for bacterial and fungal fermentation, as well as explosion-proof suites.
'Fermentation is a long-standing technology, yet new applications have been recently discovered, including the synthesis of high potency compounds, which is a major growth area currently driving contract manufacturers such as SAFC to look beyond traditional active pharmaceutical ingredient (APIs),' said SAFC president, Gilles Cottier.
'The Jerusalem expansion builds upon over 30 years of Sigma-Aldrich experience in the development and manufacture of hundreds of microbial-derived products, and is expected to help SAFC augment its industry-leading strategy of strength and expertise in emerging, highly-specialized technologies and difficult to manufacture products.'
At the Jerusalem facility, SAFC employs E.coli, Streptomyces sp., filamentous fungi and yeast, including risk group 2 human pathogens, across a wide product portfolio that includes small organic molecules and peptides, as well as larger molecules such as proteins, lipids and carbohydrates or macromolecules.
'We believe a primary differentiator at our Jerusalem site is our capability to safely manufacture niche small molecule products and biologics such as natural or recombinant proteins,' added Cottier. 'In addition to having industry-leading techniques, capability and infrastructure to manufacture fermentation derived HPAPIs, the site is a multi-disciplinary, full-service facility offering purification and analytical expertise associated with fermentation technology such as microbiology, organic chemistry, biochemistry and molecular biology.'