SAFC® Commercial – the custom manufacturing services business unit of Sigma-Aldrich – said today it will expand two U.S. manufacturing facilities to bring new targeted and cytotoxic therapies to market more quickly and cheaply, citing increased customer demand. The cost of both expansions was not disclosed.
“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,” SAFC president Gilles Cottier said in a statement.
SAFC is the second company in as many days to announce manufacturing expansion plans related in part to antibody-drug conjugates (ADCs). Yesterday, Roche said it will spend a total CHF 800 million ($874.6 million) and add 500 jobs over five years by expanding its production capacity for ADCs as well as biologic drugs.
Today, SAFC said it will raise commercial-scale manufacturing capacity for ADCs in St. Louis, and expand its high-potency active pharmaceutical ingredient (HPAPI) manufacturing and storage at its Verona facility near Madison, WI
The St. Louis expansion 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.
“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, SAFC’s head of global strategic marketing for contract manufacturing services & solutions.
SAFC added that additional commercial-scale manufacturing capacity has also been designed in St. Louis, intended to accommodate future growth in demand for ADC production.
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 designated for smaller lab-scale manufacturing in the kilo range, while the other 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, SAFC said.
Verona was originally constructed as an add-on to the Madison facility for cGMP manufacture of late-phase and commercial HPAPIs requiring 200 to 4,000 liters capacity.
“The investments at the St. Louis and Verona sites are complementary and allow SAFC to offer continuity for customers’ drug development and commercialization programs,” said Dave Bormett, the company’s director of operations.
Verona’s HPAPI handling and containment standards (<0.1 microgram/M3) enable the site to manufacture the high-potency toxins and linkers used by the St. Louis site to conjugate biological molecules and develop ADCs.
Yesterday, Roche said it will construct a new ADC manufacturing plant in Switzerland while expanding its biologics manufacturing capacity and capabilities at existing plants in Vacaville, CA, Oceanside, CA, and Penzberg, Germany. The pharma giant linked the projects to its first approved ADC – Kadcyla for HER2-positive, metastatic breast cancer – and another eight ADCs it said were in clinical development.