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Manufacturing Process


The manufacture of protein therapeutics is remarkably complex. Unlike standard pharmaceuticals, which utilize readily available chemicals as starting material and measure production cycles in hours or days, therapeutic proteins take months to produce, are derived from the plasma portion of human blood or created through biotechnology, and involve hundreds of specialized scientists and manufacturing engineers.

Because human plasma, the starting material of plasma-derived products, continues to be a finite resource, Talecris utilizes advanced technologies to make optimum use of this precious material. Talecris' primary manufacturing facility in Clayton, NC, USA, employs state-of-the-art processes for reliable, safe production of biological products. Through recent investments totaling more than $250 million, Talecris is dedicated to keeping the Clayton facility at the cutting edge of protein therapeutics production.

Innovations in Process Analytical Technology (PAT): "At a time when controversy still surrounds the application of process analytical technologies and advanced control to biopharmaceutical manufacturing, the therapeutic protein manufacturer Talecris Biotherapeutics is making great strides in improving the analysis and control of its processes. In this article, Talecris' PAT team summarizes best practices and recent examples of success."  Read "Making the Difficult Look Easy: PAT at Talecris" (PDF).
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