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:: Volume 19, Issue 4 (winter 2022) ::
Sci J Iran Blood Transfus Organ 2022, 19(4): 284-291 Back to browse issues page
Improvement of anticomplementary activity assay for the quality control of immunoglobulin product: an Iranian pilot scale study
S. Mohammadi Bidhendi , M. Bagheri , H. Khorsand Mohammadpour , S. Banazadeh , A.A. Pourfathollah , P. Kokhaei , A. Aghaie *
Keywords: Key words: Immunoglobulin, Quality Control, Plasma
Full-Text [PDF 379 kb]   (630 Downloads)     |   Abstract (HTML)  (841 Views)
Type of Study: Research | Subject: Blood Transfusion
Published: 2022/12/31
Full-Text:   (634 Views)
    References:
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  4. Krivykh MA, Kornilova OG, Bunyatyan ND,   Kudasheva  ÉY.   Optimization   of   the   Conditions for Assay of the Anti-Complement Activity of Human    Immunoglobulin Preparations for Intravenous Administration. Pharmaceutical Chemistry Journal 2015; 49(7): 473-6.












 
 


Sci J Iran Blood Transfus Organ 2022;19 (4): 284-291
 
Original Article
 
Improvement of anticomplementary activity assay for
the quality control of immunoglobulin product:
an Iranian pilot scale study

Mohammadi Bidhendi S.1, Bagheri M.1, Khorsand Mohammadpour H.2, Banazadeh S.3,
Pourfathollah A.A.4, Kokhaie P.5, Aghaie A.2

1Semnan University of Medical Sciences, Semnan, Iran
2Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran
3Fardavar Companies Group, Tehran, Iran
4Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran
5Karolinska University Hospital Solna, Stockholm, Sweden

Abstract
Background and Objectives
One of the side effects of immunoglobulin administration is the activation of the complement system related to the high concentration of aggregates/large polymers in the production process. Measuring anticomplementary activity (ACA) is important in pharmaceutical quality control and is a criterion of spontaneous activation of complement system in immunoglobulin products prepared from human plasma.

Materials and Methods
In this experimental study, ACA was established based on the European Pharmacopoeia (EP) and ACA was measured and compared in two immunoglobulin products obtained by two modified Cohn's methods A or B. The measurement is based on the ability of immunoglobulin for binding to complement and prevent the lysis of sensitized sheep red blood cells (SRBC). Therefore, immunoglobulin was incubated with guinea pig complement and then the remaining complement was titrated by CH50 method and expressed as a percentage.

Results
ACA values in two products in the two methods of A and B and in two consecutive days and eight times each day were determined to be 0.486 ± 0.08 and 0.466 ± 0.07 CH50/mg protein, respectively; compared to commercial IVIG (Biotest Company) that was 0.486 ± 0.07. ACA activity was measured as less than ≤ 1 CH50 ⁄mg IgG, which was in accordance with the requirements of the pharmacopoeia.

Conclusions 
Quantitative and qualitative immunoglobulin measurements are as valuable as research and development in plasma purification processes. With the launch of the ACA test, ACA analysis has become possible during the production process as well as in the validation stages of immunoglobulin products.

Key words: Immunoglobulin, Quality Control, Plasma


Received: 22 Aug 2022
Accepted:  1 Nov 2022


Correspondence: Aghaie A., PhD of Immunology. Associate Professor of Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine.
P.O.Box: 14665-1157, Tehran, Iran. Tel: (+9821) 82052183; Fax: (+9821) 88601599
E-mail: aghaie.a@gmail.com
 
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Mohammadi Bidhendi S, Bagheri M, Khorsand Mohammadpour H, Banazadeh S, Pourfathollah A, Kokhaei P et al . Improvement of anticomplementary activity assay for the quality control of immunoglobulin product: an Iranian pilot scale study. Sci J Iran Blood Transfus Organ 2022; 19 (4) :284-291
URL: http://bloodjournal.ir/article-1-1460-en.html
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Volume 19, Issue 4 (winter 2022) 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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