SAFC in latest biomanufacturing capacity expansion
Jerusalem, Israel manufacturing capacity for high-potency
biologics.
The site enhancement will enable the company's Pharma unit to provide process development and current good manufacturing practice (cGMP) compliatn production to customers requiring large-scale, high-potency, toxic or hazardous drug ingredients (large molecules HPAPIs). The new facility is expected to be completed in the first quarter of 2009 and will include a 50,000 sq. ft. high-potency fermentation expansion which will focus production on secondary metabolites, cytotoxins and large proteins, the company said. In addition, a 30,000 sq. ft area of the new facility has been designed to be Biosafety Level 2 compliant - enabling manipulation of human pathogens. Furthermore, site capabilities include 1,000 and 4,000-liter tank capacities for bacterial and fungal fermentation. "This expansion builds on the fermentation track record of our Jerusalem facility while adding significantly to our HPAPI capacity. It is consistent with SAFC's strategy to extend the range and scope of coverage in niche technologies and APIs for biologics sectors," said Frank Wicks, SAFC president. SAFC Pharma has been investing heavily in the biologics field of late and recently acquired its third biologic contract manufacturer in four years. The purchase of California-based Molecular Medicine Bioservices (MMB) in May was intended to help the firm focus on the booming area of biopharmarceuticals. In 2004 SAFC - part of the Sigma-Aldrich group - bougth its first two biologics buinesses, UK firm Ultrafine and US-based Tetroinics, with the intention to fully enter the biologic drug manufacturing market. This latest investment in Israel complements the recent completion of the construction of two protein API facilities at its St Louis, Missouri site. The company said it invested in the $16m expansion in order to meet increased market demand for therapeutic proteins derived from plant- and animal-sourced materials. The new operations feature two separate facilities in order to eliminate potential cross-contamination, SAFC said in May. A new 25,000 sq. ft biologics manufacturing facility with a purification and manufacturing suite will be dedicated to transgenic plant and non-animal derived protein APIs while animal-derived protein purification will be conducted in a separate 6,000 sq. ft facility, the company said.
