SAFC Pharma's St. Louis HPAPI Conjugates Facility Receives SafeBridge Certification

SAFC Pharma (St. Louis, MO) has received certification by SafeBridge Consultants, Inc., for the safe handling of potent drug substances of its highly potent active pharmaceutical ingredient (HPAPI) conjugation suite, located in St. Louis, MO. The suite was designed to support the entire drug development pipeline, from early-stage clinical supplies to kilogram quantities, and expandable to commercial-scale.

The SafeBridge program assessment, recognized as the most widely accepted industry benchmark for handling highly potent pharmaceuticals, focuses on four primary areas: management; hazard identification and evaluation; hazard controls; and communication, education, and training.

The SafeBridge certification of the St. Louis HPAPI suite adds to SAFC investments totaling $75 million during the past 18 months to expand its HPAPI capacity. Those include a $4.5 million project to add a cGMP pilot plant and kilo-laboratory capacity at the Madison, WI, facility, completed in early 2008; a $29 million investment to expand bacterial and fungal fermentation derived HPAPI capacity at Jerusalem, Israel, due for completion in early 2010; and a $30 million investment to build a new commercial-scale HPAPI facility at Madison, WI, expected to be completed by year-end 2009.