SAFC’s pharma business segment is expanding its cGMP protein purification capacity to meet increased market demand for therapeutic proteins from plant and animal sources. Upon completion in April of 2007, the natural and recombinant plant protein purification facility is expected to be one of the world’s largest therapeutic protein production sites, according to the company.
“Recent successes in the transgenic plant market combined with advancements of several of our natural active pharmaceutical ingredients derived from plants have provided impetus to expand our capacity, explains Frank Wicks, president. “We have several projects moving into late-stage clinical trials and commercial manufacturing and are expanding to meet growing customer demand.”
The new operations, part of a 400,000-sq-ft St. Louis, MO, manufacturing campus, will feature completely separate plant and animal protein processing facilities to eliminate potential cross-contamination. A dedicated natural and recombinant plant proteins facility will occupy 22,000 sq. ft. for its upstream and downstream processing operations. A separate animal-sourced proteins facility will encompass over 20,000 sq. ft. for upstream processing and be supported by an area that contains over 300,000 sq. ft. of total capacity. Downstream animal-sourced purification will take place in an adjacent 5,000-sq-ft cleanroom suite.
SAFC is working closely with numerous transgenic plant platform companies to develop commercial-scale processes for proteins previously available only from animal-sourced materials and for therapeutic proteins and Mabs. The company is also experiencing strong demand for cGMP proteins from animal-sourced materials for use in medical device applications and APIs.