SAFC Wisconsin site keeps on growing

The latest upgrade to the site involves a $4.5m capacity expansion program due to start early next year, as well as the installation of new X-ray powder diffraction (XRPD) analytical equipment for solid form testing later this month. The additional capacity will come in the form of a current good manufacturing practice (cGMP) compliant pilot plant and kilo lab capacity. Two 400-liter pilot plant reactors and a pair of 100-liter portable jacketed reactors will be introduced into a dedicated 1200 sq ft. large-scale kilo lab. The new additions are intended to increase capacity for SAFC's custom HPAPI manufacturing business, and enable larger-scale chromatography for process purification. SAFC, the manufacturing subsidiary of Sigma-Aldrich, has also decided to install solid form testing and analysis equipment at the flagship site, enabling the company to provide such services to its US customers. The firm has opted for a Bruker D8 Advance X-ray Diffractometer in its own dedicated lab space, to offer customers on-site cGMP and XRPD analysis of potent compounds. This rapid sample testing that will now be available at the Madison site is presented as sitting well with the data analysis and evaluation services performed at the company's facilities in the UK. The UK activities take place at the firm's recently acquired Pharmorphix site in Cambridge. The privately held firm was acquired by SAFC in August last year, and provides solid-form research services to support regulatory and intellectual property submissions, and help extend the patent life of new therapeutic drugs. Earlier this year the company announced the initiation of a two-stage, $1.2m expansion at the Pharmorphix research facility, intended to meet the anticipated increase in demand for the services offered by the business unit. With Pharmorphix only one of a handful of organizations specializing in solid form characterization and research, expanding the unit's capacity and bringing its technology services to the US seems a logical move for new owner SAFC. "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 SAFC president Frank Wicks. "Additional and enhanced capabilities at SAFC Pharma's Madison facility mark a timely expansion to the scope and value of our HPAPI offering." ​ The Madison facility only just completed its last refit, with a $12m, 38,000 sq ft. expansion that doubled the plant's size completed in 2006. As well as the seemingly constant growth of the Madison facility and the Pharmorphix acquisition, SAFC also recently bought Iropharm's Arklow, Ireland custom chemical synthesis business, providing it with another 90,000 liters of cGMP manufacturing capacity. Yet another recent investment came in the form of a $16m expansion of the company's protein purification capabilities at its St. Louis, Missouri to meet the growing demand from the biopharmaceutical market. The expansion was completed in April this year, with two new protein API facilities that comprise some of the largest extraction and purification suites of their kind, according to the company.