Talecris purification process, here's a tidbit I found. It's hard to imagine that tweaking chromatography, as they apparently have done, could lead to more than something like doubling (or likely much less) of supply. Unless that is, traditional methods are horribly inefficient, which I doubt is the case. Nevertheless, we have stumbled onto another question. If we can determine how inefficient traditional methods are, then we will know the upper limit for increases in yield from human plasma.
Int Immunopharmacol. 2006 Apr;6(4):517-22. Epub 2005 Dec 13.
IGIV: contents, properties, and methods of industrial production--evolving closer to a more physiologic product.
Martin TD.
Genesis Medical Marketing Consultants, LLC, 30192 Highway M, Sedalia, MO 65301, USA.
Is the process the product? Immune globulin intravenous (IGIV) is not manufactured, but is purified (fractionated) from human plasma. Machines can only damage what Mother Nature makes; they cannot improve it. Therefore, fractionators of biologic molecules must strive to ensure what is taken from a human body is exactly the same when it is returned to the human body for optimal tolerability and safety. The processes of purification have the potential to adversely affect the product. Four primary purification processes exist for commercial IGIV. The Cohn-Oncley process is 1940s technology, which has been modified through the decades, but the basic process remains unchanged. The Kistler-Nitschmann process was developed in the 1950s by the Central Laboratory of the Swiss Red Cross (ZLB, today known as ZLB-Behring, a subsidiary of CSL Limited). Various attempts have been made to utilize chromatography as the sole separation technology without much success. Most recently, Bayer HealthCare (Talecris Biotherapeutics acquired the contributed assets of the worldwide plasma business of Bayer Biological Products and became operational April 1, 2005; all plasma-based products, including Gamunex, Prolastin, the hyperimmune line (Fraction II), Plasbumin (Bayer Albumin), Koate DVI, and Thrombate III were included) introduced a new product into the United States and Canada that utilizes caprylate and chromatography for high purity, better yields, and integration of safety and efficacy. This is the first new IGIV purification technology in over 20 years.
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Note on caprylate from the Gamunex website:
The Gamunex® production process uses caprylate, a plant-derived, naturally occurring fatty acid. The caprylate purification process treats the fragile immunoglobulins much more gently to better preserve their effectiveness.
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