SAFC Invests in Commercial?-Scale ADC Conjugatio?n Manufactur?ing and Services; Expands HPAPI Manufactur?ing and Storage Capacity

Sigma-Aldrich Corporation’s custom manufacturing services business unit, SAFC Commercial (www.sigma-aldrich.com/safc), is expanding two of its manufacturing facilities in the US to support drug manufacturers in efficiently bringing new targeted and cytotoxic therapies to market. As a direct result of increasing customer demand, 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.

“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.”

The ADC expansion at the St. Louis site is expected to be completed by mid-2015. The updated facility will feature 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 seamlessly accommodate future growth in demand for ADC production.

“Once complete, the St. Louis expansion will enable continuous scale-up of ADCs from preclinical to clinical phases and into commercial-scale production,” said Andreas Weiler, Head of Global Strategic Marketing for Contract Manufacturing Services & Solutions at SAFC. “ADC technologies have shown exceptional promise in targeted therapies for chronic diseases, such as cancer, so strategic investments in this facility made sense to support our customers through all phases of ADC innovation.”

“The investments at the St. Louis and Verona sites are complementary and allow SAFC to offer continuity for customers’ drug development and commercialisation programmes,” said Dave Bormett, Director of Operations for SAFC. “Verona’s HPAPI handling and containment standards (<0.1 microgram/M3) enable the site to manufacture the high-potency toxins and linkers that the St. Louis site uses to conjugate biological molecules and develop ADCs. It is all a part of our drive to provide customers with complete solutions based on our expertise in niche technologies.”

Online since mid-2010, and SafeBridge certified in October 2011, Verona was originally constructed as an add-on to the Madison facility for cGMP manufacture of late-phase and commercial HPAPIs requiring 200–4000 L capacity. By mid-2014, the 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 designated for smaller lab-scale manufacturing in the kilo range, and the other will accommodate larger-scale manufacturing up to 800 L. 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.