SAFC Commercial, the custom manufacturing services business unit of Sigma-Aldrich Corp., is expanding two of its manufacturing facilities in the U.S. to support the manufacture of targeted and cytotoxic therapies. SAFC is investing in commercial-scale manufacturing capacity for antibody drug conjugates (ADCs) in St. Louis, MO, and expanding its high-potency active pharmaceutical ingredient (HPAPI) manufacturing and storage at the Verona facility near Madison, WI.
The ADC expansion is expected to be complete by mid-2015. The updated facility will have segregated areas for high-potent solids handling, manufacturing and aseptic bulk filling of product. Batches up to 600L/3kg can be manufactured under ISO 7 classification and the facility is suitable for HPAPI containment for SafeBridge Category 4 compounds. Additional commercial-scale manufacturing capacity has also been designed to accommodate future production growth.
By mid-2014, the Verona site will have a new warehouse with storage capacity for raw materials, as well as three new cGMP manufacturing areas to support projects. Two of the areas will be for smaller lab-scale manufacturing in the kilo range. The other area will accommodate larger-scale manufacturing up to 800 liters. The facility expansion will also provide space for growth of SAFC’s product stability sample storage and testing service, as well as a process scale-up lab to support GMP production.
“These strategic investments are the result of ongoing dialogue with customers. We are directly addressing their needs for supply chain continuity when sourcing the high-quality manufacturing materials, technologies and services that drive the performance of their end products,” said Gilles Cottier, president of SAFC. “Bringing commercial-scale ADC capacity to St. Louis and augmenting the offer at Verona to feature expanded HPAPI manufacturing and storage capabilities are direct reflections of SAFC’s commitment to investing in support of our customers.”