IGIV: Contents, properties, and methods of industrial production - evolving closer to a more physiologic product
IGIV: Contents, properties, and methods of industrial production - evolving closer to a more physiologic product
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DOI：
10.1016/j.intimp.2005.11.005
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发表时间：
2006-04-01
影响因子：
5.6
通讯作者：
Martin, TD
中科院分区：
文献类型：
--
作者：
Martin, TD
过程就是产品吗？静脉注射免疫球蛋白 (IGIV) 不是制造的，而是从人血浆中纯化（分馏）的。机器只能破坏大自然的创造；他们无法改进它。因此，生物分子分馏者必须努力确保从人体取出的物质返回人体时完全相同，以获得最佳的耐受性和安全性。纯化过程有可能对产品产生不利影响。商业 IGIV 存在四种主要纯化工艺。 Cohn-Oncley工艺是20世纪40年代的技术，几十年来一直在改进，但基本工艺保持不变。 Kistler-Nitschmann 工艺由瑞士红十字会中央实验室（ZLB，现称为 ZLB-Behring，CSL Limited 的子公司）于 20 世纪 50 年代开发。人们已经进行了各种尝试来利用色谱法作为唯一的分离技术，但没有取得太大成功。最近，拜耳医药保健（Talecris Biotherapeutics 收购了拜耳生物制品公司全球血浆业务的出资资产，并于 2005 年 4 月 1 日开始运营；所有基于血浆的产品，包括 Gamunex (R)、Prolastin (R)、超免疫系列（Fraction II）、Plasbumin (R)（拜耳白蛋白）、Koate (R) DVI 和 Thrombate III (R)）推出了一款新产品进入美国和加拿大，利用辛酸盐和色谱法获得高纯度、更高的收率以及安全性和有效性的结合。这是 20 多年来首个新的 IGIV 纯化技术。 (c) 2005 Elsevier B.V. 保留所有权利。
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 (R), Prolastin (R), the hyperimmune line (Fraction II), Plasbumin (R) (Bayer Albumin), Koate (R) DVI, and Thrombate III (R) 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. (c) 2005 Elsevier B.V. All rights reserved.