کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
2542729 1122734 2006 6 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
IGIV: Contents, properties, and methods of industrial production—evolving closer to a more physiologic product
موضوعات مرتبط
علوم زیستی و بیوفناوری ایمنی شناسی و میکروب شناسی ایمونولوژی
پیش نمایش صفحه اول مقاله
IGIV: Contents, properties, and methods of industrial production—evolving closer to a more physiologic product
چکیده انگلیسی

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.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: International Immunopharmacology - Volume 6, Issue 4, April 2006, Pages 517–522
نویسندگان
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