SAFC Commercial, the custom manufacturing services business unit of Sigma-Aldrich Corporation (SIAL), said that it is expanding two U.S. production facilities to help drug makers in launching new targeted and cytotoxic therapies in the market.
SAFC will expand a commercial-scale antibody drug conjugates (ADC) manufacturing facility in St. Louis, MO, and boost the high-potency active pharmaceutical ingredient (:HPAPI) production and storage capacity at the Verona facility near Madison, WI. These initiatives mirror SAFC’s commitment to support customers’ continuity in drug development and commercialization programs.
SAFC expects to complete the expansion of the St. Louis plant by mid-2015. There will be separate areas for high-potent solids handling, manufacturing and aseptic bulk filling of products at the renovated facility. The plant will then be capable of manufacturing batches of up to 600 Liter per 3 kg under ISO 7 classification and will be ideal for HPAPI containment for SafeBridge Category 4 compounds.
The expanded plant will have an additional commercial-scale manufacturing capacity. The capacity will facilitate meeting any increase in demand for ADC production in future. The expansion will also allow the ADC production to seamlessly transition from preclinical to clinical phases and into commercial-scale production. ADC technologies are highly suitable for target therapies for chronic diseases like cancer.
The renovated Verona facility, which will be specially designed with HPAPI handling and containment standards (3), will provide an ideal set-up to produce the high-potency toxins and linkers that are used by the St. Louis site to conjugate biological molecules and develop ADCs.
The expanded Verona facility will have three new cGMP production areas and a new warehouse with raw materials storage capacity by mid-2014. Two of the three new cGMP manufacturing areas will be used for smaller lab-scale manufacturing and the remaining one for larger-scale manufacturing of up to 800 liters. The expansion of the Verona facility will also create space for expansion of SAFC's product stability sample storage and testing service, and for a process scale-up lab for GMP production.
Sigma-Aldrich is among the leading players in the specialty chemical space along with American Pacific Corp. (APFC) and American Vanguard Corp. (AVD). It is a leading life sciences and high technology company. It develops, manufactures and distributes various biochemicals and organic chemicals.
The SAFC Commercial unit is focused on biochemical production and manufacturing of complex organic compounds. The division manufactures and distributes bulk quantities of organic chemicals and biochemicals used by pharmaceutical, biotechnology, industrial, and diagnostic companies to develop and produce therapeutics.
Sigma-Aldrich carries a Zacks Rank #2 (Buy).
Ferro Corp. (FOE), with a Zacks Rank #1 (Strong Buy), is a good option for investment in the specialty chemical industry.