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:: Volume 5, Issue 2 (Summer 2008) ::
Sci J Iran Blood Transfus Organ 2008, 5(2): 81-88 Back to browse issues page
Purification of intravenous immunoglobulin (IVIG) from fraction II paste
A. Aghaie , A.A. Pourfathollah , S.Z. Bathaie , S.M. Moazzeni , H. Khorsand Mohammad Pour
Abstract:   (22451 Views)

  Abstract

 Background and Objectives

 Intravenous immunoglobulin (IVIG) preparations are used in several disorders including primary and secondary immunodeficiencies, autoimmune and systemic inflammatory diseases it is also applied in effective therapy of infectious diseases. IVIG is currently the most widely used plasma component in the world . The addition of multiple steps to the manufacturing process of IVIG lowers the yield of IgG and raises the manufacturing costs. Therefore, manufacturers attempt to employ a cost effective method with respect to safety and quality of the product. In this study we proposed a method which not only reduced the manufacturing steps but also raised product safety by the treatment of pasteurization as a virus inactivation method.

 

 Materials and Methods

 For this experimental study, the fraction II paste (rich in IgG) was obtained from fresh frozen plasma (FFP) by the modified cold ethanol fractionation method (Cohn’s method). For further purification, filtration was used to remove impurities. Before performing virus inactivation by pasteurization, protein solution was diafiltered and then the stabilizer was added. Pasteurized solution was diafiltered again and final product was prepared after sterile filtration.

 

 Results

 The quality control results of the finished product obtained by the proposed method revealed that the purity was 100% (determined by cellulose acetate electrophoresis) and the polymer amount was less than 1% (evaluated by HPLC chromatography). The secondary and tertiary structures of IgG molecule were also examined by circular dichroism spectroscopy technique and were then compared to the commercial IVIG products bringing about approximately similar and satisfactory results. The yield calculated for the initial amount of IgG of plasma was 39.1% as measured by nephelometery.

 

 Conclusions

 The high purity of the finished product confirmed that the proposed purification process was satisfactory in despite of fewer steps when compared to the current methods. Indeed, the cost- effective preparation together with quatily and safety are taken into account in the proposed method. If the complementary experiments are carried out, the proposed method can escalate at the industry scale.

 

 Key words : Plasma, Purification, Intravenous immunoglobulin, Cohn fraction II

 

Keywords: Plasma, Purification, Intravenous immunoglobulin, Cohn fraction II
Full-Text [PDF 303 kb]   (2767 Downloads)    
Type of Study: Research | Subject: Imunology
Published: 2014/08/17
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Aghaie A, Pourfathollah A, Bathaie S, Moazzeni S, Khorsand Mohammad Pour H. Purification of intravenous immunoglobulin (IVIG) from fraction II paste . Sci J Iran Blood Transfus Organ 2008; 5 (2) :81-88
URL: http://bloodjournal.ir/article-1-235-en.html


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Creative Commons License This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Volume 5, Issue 2 (Summer 2008) Back to browse issues page
فصلنامه پژوهشی خون Scientific Journal of Iran Blood Transfus Organ
The Scientific Journal of Iranian Blood Transfusion Organization - Copyright 2006 by IBTO
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