publication . Article . Part of book or chapter of book . 2019

Reference materials used for specific safety evaluation of human immunoglobulin and human albumin products: features of development, certification and application

Olga G. Kornilova; Maxim A. Krivykh; Rauza A. Volkova; Igor V. Borisevich;
Open Access
  • Published: 02 Apr 2019
  • Publisher: Ural Research Institute of Metrology (UNIIM)
Abstract
Human immunoglobulin and human albumin products can negatively affect patients’ health. The residual content of haemagglutinins, anti-D antibodies, prekallikrein activator, as well as the level of anticomplementary activity, are controlled during both production and testing for compliance with normative documentation. Methods for their quantitative evaluation are based on the effects of erythrocytes hemolysis or agglutination and on the amidolytic product properties of cascade reactions. These methods require the obligatory use of reference materials (RMs). The development of RMs, acting as the carrier of the quantitative characteristics of the human immunoglobu...
Subjects
free text keywords: quality control, human immunoglobulin products, human albumin products, specific safety, anticomplementary activity, anti-a and anti-b haemagglutinins, anti-d antibodies, prekallikrein activator, reference materials, hemagglutination methods, complement fixation test, chromogenic assay, Human immunoglobulin, Qualitative composition, Hemagglutinin, Human albumin, Human immunoglobulins, Prekallikrein Activator, Chemistry, Chromatography, Complement fixation test, Hemagglutination, Antibody, biology.protein, biology, Hemolysis, medicine.disease, medicine, Agglutination (biology), Certification, lcsh:Technology, lcsh:T
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