SAFC Pharma has commissioned a new suite at its St. Louis campus that will produce high-potency active pharmaceutical ingredient (HPAPI) conjugates to support oncology drug development. The 600-sq.-ft. suite will enable the conjugation of HPAPIs to a variety of targeted delivery molecules, including monoclonal antibodies. The new facility can also accommodate early-stage clinical supplies and can handle multi-kilogram quantities, with the capability to expand production up to commercial-scale.

"Bio-conjugates represent the next generation of 'smart munitions' in healthcare's anti-cancer arsenal," said Dave Feldker, SAFC Pharma vice president. "Due to our significant breadth of chemistry, containment engineering and biologics capabilities, SAFC Pharma is well-positioned as the leading player in this exciting niche.

"The HPAPI market has grown at a high double-digit pace; the number of customers we have has more than doubled over the past three years, with particular demand growth for biologic-HPAPI conjugates for oncology drugs," Mr. Feldker continued. "Dozens of products are currently in clinical trials, and this new facility underline's SAFC's intent to support growth in this niche, strengthening our position as the leading pipeline partner for the pharmaceutical and biopharmaceutical industry."

During the past year, the company has announced investments totaling $75 million to expand HPAPI capacity, including a $4.5 million project to add a cGMP pilot plant and kilo-lab capacity at Madison, WI, completed earlier this year; a $29 million investment to expand bacterial and fungal fermentation-derived HPAPI capacity in Jerusalem, due for completion in 2009; and a $30 million investment to build a commercial-scale HPAPI facility at Madison, due to be completed by year-end 2009.