Facility will produce HPAPIs, secondary metabolites, cytotoxins, and recombinant proteins.
SAFC completed expansion of its Jerusalem facility, which expands the company’s contract manufacturing capabilities in both recombinant proteins and small molecules. The 50,000 sq. ft. cGMP fermentation expansion, which is expected to begin production later this month, will focus on niche fermentation of APIs and bulk drugs, producing high-potent APIs (HPAPI), secondary metabolites, cytotoxins, and large-molecule proteins.
A 30,000 sq. ft. area of the new facility has been designed to be Biosafety Level 2 compliant, enabling manipulation of human pathogens. Capabilities include 1,000 L and 4,000 L tank capacities for bacterial and fungal fermentation as well as explosion-proof suites.
At the Jerusalem facility, SAFC employs E. coli, Streptomyces sp., filamentous fungi, and yeast including risk group 2 human pathogens across a 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,” remarks SAFC president, Gilles Cottier. “In addition to having industry-leading techniques, capability, and infrastructure to manufacture fermentation-derived HPAPIs, the site is a multidisciplinary, full-service facility offering purification and analytical expertise associated with fermentation technology such as microbiology, organic chemistry, biochemistry, and molecular biology.
“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 ingredients,” Cottier adds.
The company has two HPAPI facilities in Wisconsin. In April it opened a 51,000 sq. ft. site in Verona, WI, to complement the 63,000 sq. ft. facility already in Madison, WI. SAFC spent $30 million on the Verona plant so that it could support Phase III and commercial HPAPI requirements. It has reactors capable of producing HPAPI batch sizes of up to 4,000 liters, 10 times greater than the capacity at the Madison site. The facility includes a 150 liter mini-processing plant, two large-scale cGMP manufacturing suites, and a potent compound-packaging area.