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Quantitative determination of activated coagulation factor XI as an impurity in therapeutic immunoglobulins from Chinese blood fractionation companies.
Genet Mol Res. 2013 Jul 24; 12(3):2556-61.GM

Abstract

Residual activated coagulation factor XI (FXIa) has been suggested to play an important role in thromboembolic events associated with the use of intravenous immunoglobulin (IVIG) lots. This study investigated the predominant plasma proteases in 42 IVIG lots from 4 Chinese manufacturers. In one-stage clotting assays, the procoagulant activities of factors II, VII, IX, X, XI, and XII were quantified. Non-activated partial thromboplastin time and a modified thrombin generation test served as global and FXIa-specific clotting assays, respectively. We found that coagulation factor clotting activities of the 42 IVIG lots were below the detection limit of the assays, except for the products of manufacturer B (lots of 2010), in which 0.030 to 0.032 IU/mL FXI:C were detected. The peak time of thrombin using a thrombin generation test was greater than 35 min, the relevant amount of FXIa was below 0.37 nM, and non-activated partial thromboplastin time was greater than 200 s. Consequently, the 42 IVIG lots showed non-significant procoagulant potential. Further study is required to determine whether a program for FXIa determination in IVIG products should be launched in China.

Authors+Show Affiliations

Institute of Blood Transfusion, Chinese Academy of Medical Sciences, Chengdu, Sichuan, China.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23315876

Citation

Ma, L, et al. "Quantitative Determination of Activated Coagulation Factor XI as an Impurity in Therapeutic Immunoglobulins From Chinese Blood Fractionation Companies." Genetics and Molecular Research : GMR, vol. 12, no. 3, 2013, pp. 2556-61.
Ma L, Sun P, Lin FZ, et al. Quantitative determination of activated coagulation factor XI as an impurity in therapeutic immunoglobulins from Chinese blood fractionation companies. Genet Mol Res. 2013;12(3):2556-61.
Ma, L., Sun, P., Lin, F. Z., Diao, G., & Li, C. Q. (2013). Quantitative determination of activated coagulation factor XI as an impurity in therapeutic immunoglobulins from Chinese blood fractionation companies. Genetics and Molecular Research : GMR, 12(3), 2556-61. https://doi.org/10.4238/2013.January.4.17
Ma L, et al. Quantitative Determination of Activated Coagulation Factor XI as an Impurity in Therapeutic Immunoglobulins From Chinese Blood Fractionation Companies. Genet Mol Res. 2013 Jul 24;12(3):2556-61. PubMed PMID: 23315876.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Quantitative determination of activated coagulation factor XI as an impurity in therapeutic immunoglobulins from Chinese blood fractionation companies. AU - Ma,L, AU - Sun,P, AU - Lin,F Z, AU - Diao,G, AU - Li,C Q, Y1 - 2013/07/24/ PY - 2013/1/15/entrez PY - 2013/1/15/pubmed PY - 2014/2/13/medline SP - 2556 EP - 61 JF - Genetics and molecular research : GMR JO - Genet Mol Res VL - 12 IS - 3 N2 - Residual activated coagulation factor XI (FXIa) has been suggested to play an important role in thromboembolic events associated with the use of intravenous immunoglobulin (IVIG) lots. This study investigated the predominant plasma proteases in 42 IVIG lots from 4 Chinese manufacturers. In one-stage clotting assays, the procoagulant activities of factors II, VII, IX, X, XI, and XII were quantified. Non-activated partial thromboplastin time and a modified thrombin generation test served as global and FXIa-specific clotting assays, respectively. We found that coagulation factor clotting activities of the 42 IVIG lots were below the detection limit of the assays, except for the products of manufacturer B (lots of 2010), in which 0.030 to 0.032 IU/mL FXI:C were detected. The peak time of thrombin using a thrombin generation test was greater than 35 min, the relevant amount of FXIa was below 0.37 nM, and non-activated partial thromboplastin time was greater than 200 s. Consequently, the 42 IVIG lots showed non-significant procoagulant potential. Further study is required to determine whether a program for FXIa determination in IVIG products should be launched in China. SN - 1676-5680 UR - https://www.unboundmedicine.com/medline/citation/23315876/Quantitative_determination_of_activated_coagulation_factor_XI_as_an_impurity_in_therapeutic_immunoglobulins_from_Chinese_blood_fractionation_companies_ L2 - http://www.geneticsmr.com/articles/2012 DB - PRIME DP - Unbound Medicine ER -