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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. bloodj 2022; 19 (4) :284-291
URL: http://bloodjournal.ir/article-1-1460-en.html
URL: http://bloodjournal.ir/article-1-1460-en.html
S. Mohammadi Bidhendi 
, M. Bagheri , H. Khorsand Mohammadpour , S. Banazadeh , A.A. Pourfathollah 
, P. Kokhaei , A. Aghaie *
, M. Bagheri , H. Khorsand Mohammadpour , S. Banazadeh , A.A. Pourfathollah , P. Kokhaei , A. Aghaie *
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| Abstract (HTML) (1615 Views)
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
Full-Text: (958 Views)
References:
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- European Pharmacopeia: Human normal immunoglobulin for intravenous administration. Strasbourg Cedex, France: European Pharmacopeia 6.3; 2009. p. 4166-8.
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- Krivykh M, Kornilova O, Bunyatyan N, 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.
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- 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.
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Sci J Iran Blood Transfus Organ 2022;19 (4): 284-291 |
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Original Article
|
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
Type of Study: Research |
Subject:
Blood Transfusion
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