PURIFICATION OF INTRAVENOUS IMMUNOGLOBULIN (IVIG) FROM FRACTION II PASTE

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AGHAEI AFSANEH; POURFATH ELAH A.A.; BATHAEI S.Z.; MOAZENI S.M.; KHORSAND MOHAMMADPOUR H.

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Journal: The Scientific Journal of Iranian Blood Transfusion Year:2008 | Volume:5 | Issue:2 (19) Page(s): 81-88

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Title

PURIFICATION OF INTRAVENOUS IMMUNOGLOBULIN (IVIG) FROM FRACTION II PASTE

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Keywords

PLASMAQ3

PURIFICATIONQ4

INTRAVENOUS IMMUNOGLOBULINQ4

COHN FRACTION IIQ4

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 costeffective 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.

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APA: Copy

AGHAEI, AFSANEH, POURFATH ELAH, A.A., BATHAEI, S.Z., MOAZENI, S.M., & KHORSAND MOHAMMADPOUR, H.. (2008). PURIFICATION OF INTRAVENOUS IMMUNOGLOBULIN (IVIG) FROM FRACTION II PASTE. THE SCIENTIFIC JOURNAL OF IRANIAN BLOOD TRANSFUSION ORGANIZATION (KHOON), 5(2 (19)), 81-88. SID. https://sid.ir/paper/78539/en

Vancouver: Copy

AGHAEI AFSANEH, POURFATH ELAH A.A., BATHAEI S.Z., MOAZENI S.M., KHORSAND MOHAMMADPOUR H.. PURIFICATION OF INTRAVENOUS IMMUNOGLOBULIN (IVIG) FROM FRACTION II PASTE. THE SCIENTIFIC JOURNAL OF IRANIAN BLOOD TRANSFUSION ORGANIZATION (KHOON)[Internet]. 2008;5(2 (19)):81-88. Available from: https://sid.ir/paper/78539/en

IEEE: Copy

AFSANEH AGHAEI, A.A. POURFATH ELAH, S.Z. BATHAEI, S.M. MOAZENI, and H. KHORSAND MOHAMMADPOUR, “PURIFICATION OF INTRAVENOUS IMMUNOGLOBULIN (IVIG) FROM FRACTION II PASTE,” THE SCIENTIFIC JOURNAL OF IRANIAN BLOOD TRANSFUSION ORGANIZATION (KHOON), vol. 5, no. 2 (19), pp. 81–88, 2008, [Online]. Available: https://sid.ir/paper/78539/en

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