Development of a Reference Standard for the Determination of Human Immunoglobulin Anticomplementary Activity

Results of studies devoted to determination of the anticomplementary activity of human immunoglobulin preparations in various formulations were presented. The optimal conditions for developing a positive control, i.e., a reference standard of human immunoglobulin that can be used for determining the...

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Published inPharmaceutical chemistry journal Vol. 49; no. 6; pp. 398 - 400
Main Authors Krivykh, M. A., Kornilova, O. G., Bunyatyan, N. D., Kudasheva, É. Yu, Runova, O. B., Malkova, V. I., Ustinnikova, O. B.
Format Journal Article
LanguageEnglish
Published New York Springer US 01.09.2015
Springer
Subjects
Immunoglobulins
Medicine
Organic Chemistry
Pharmacology/Toxicology
Pharmacy
reference standard
standardization
human immunoglobulin
anticomplementary activity
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Summary:Results of studies devoted to determination of the anticomplementary activity of human immunoglobulin preparations in various formulations were presented. The optimal conditions for developing a positive control, i.e., a reference standard of human immunoglobulin that can be used for determining the anticomplementary activity, were defined. The first domestic reference sample of human immunoglobulin was developed. This standard is intended to be used for quality assessment of human immunoglobulin preparations for intravenous administration in terms of an anticomplementary activity parameter. Use of the proposed reference standard of human immunoglobulin for determination of anticomplementary activity will improve the evaluation accuracy of commercial human immunoglobulin preparations for intravenous administration.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-015-1292-y