Development and Certification of a Standard Sample for Determining Anti-D Antibody Contents in Human Immunoglobulin Preparations

Materials for the development and certification of a standard sample for anti-D antibody contents in human immunoglobulin drugs are presented. Preparation of the negative component of the standard sample from blood plasma of Rh-positive group IV(AB) donors without anti-D antibodies; the positive com...

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Bibliographic Details
Published in:Pharmaceutical chemistry journal 2020-06, Vol.54 (3), p.325-328
Main Authors: Kornilova, O. G., Nechaev, A. V., Khusnatdinova, E. A., Yakovlev, A. K., Olefir, Yu. V.
Format: Article
Language:English
Subjects:
Antibodies
Biological products
Medicine
Organic Chemistry
Pharmacology/Toxicology
Pharmacy
Viral antibodies
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Summary:Materials for the development and certification of a standard sample for anti-D antibody contents in human immunoglobulin drugs are presented. Preparation of the negative component of the standard sample from blood plasma of Rh-positive group IV(AB) donors without anti-D antibodies; the positive component, from blood plasma of Rh-negative group IV(AB) donors is justified. The immunoglobulin should be concentrated to produce a solution with protein contents in the range 48 – 51 mg/mL and anti-D antibody titer 1:8. Flow cytofluorimetry is shown to allow standardization of the preparation of the standard sample positive component.
ISSN:0091-150X
1573-9031
DOI:10.1007/s11094-020-02199-7