GTC Biotherapeutics, Inc. (GTC, Framingham, MA) has entered into an extended agreement with PharmAthene, Inc. (Annapolis, MD) under which GTC will provide continuing process development and clinical supply manufacturing services for PharmAthene’s Protexia program.
GTC Biotherapeutics, Inc. (GTC, Framingham, MA) has entered into an extended agreement with PharmAthene, Inc. (Annapolis, MD) under which GTC will provide continuing process development and clinical supply manufacturing services for PharmAthene’s Protexia program. The manufacturing work is planned to conclude in the third quarter of 2008. Protexia is a recombinant form of human butyrylcholinesterase (rBChE) produced in the milk of transgenic goats, which is being developed by PharmAthene as a pre- and post-exposure therapy for victims of a chemical nerve agent attack.
Although the use of human plasma derived butyrylcholinesterase (BChE) to protect against nerve agent toxicity is well documented, a major limitation hindering its commercial development has been the inability to produce commercial quantities because of a limited availability of appropriate blood supplies, low levels of the protein in plasma, and low production yields using traditional biotechnology methods. Protexia overcomes these limitations by enabling substantially larger production yields than are possible using other expression systems or through purification of the native protein from human plasma. Transgenic production and manufacturing is estimated to be capable of supplying sufficient rBChE to make Protexia available for use by the military and civilian populations.
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