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Patricia Van Arnum was executive editor of Pharmaceutical Technology.
SAFC, the custom manufacturing group of Sigma-Aldrich Corporation, announced at CPhI Worldwide that it will invest $16 million to expand its CGMP protein-purification capacity to meet increased market demand for therapeutic proteins from plant- and animal-sourced starting materials.
Paris (Oct, 3)-SAFC (St. Louis, MO, www.safcglobal.com), the custom manufacturing group of Sigma-Aldrich Corporation (St. Louis, MO, www.sigmaaldrich.com), announced at CPhI Worldwide that it will invest $16 million to expand its CGMP protein-purification capacity to meet increased market demand for therapeutic proteins from plant- and animal-sourced starting materials. The new operations will be part of a 400,000-ft2 manufacturing campus in St. Louis, Missouri. The expansion is slated to be completed by April 2007.
The new operations will feature separate plant and animal protein processing facilities to eliminate potential cross-contamination, said SAFC in release. A dedicated natural and recombinant (transgenic) plant protein facility will occupy 22,000 ft2 for upstream and downstream processing. A separate animal-sourced proteins facility will encompass more than 20,000 ft2 for upstream processing and be supported by an area that contains more than 300,000 ft2 of total capacity. Downstream purification of animal-derived products will take place in an adjacent 5,000 ft2 cleanroom suite.
“Recent successes in the transgenic plant market combined with advancements of several of our natural active pharmaceutical ingredients (APIs) derived from plants have provided impetus to expand our capacity,” said Frank Wicks, SAFC president. “We have several projects in late-stage clinical trials and commercial manufacturing and are expanding to meet growing customer demand.”
The expansion is the latest in a series of capacity and technology expansions by SAFC in 2006. These include: the acquisitions of a large-scale API manufacturing site in Arklow, Ireland and of Pharmorphix (Cambridge, UK), a solid-state research company; expansion of a high-potency manufacturing facility in Madison, Wisconsin; and work-shift extensions at SAFC's API manufacturing site in Gillingham, United Kingdom and medicinal chemistry and development facilities in Manchester, United Kingdom.