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

Autor:	O. G. Kornilova, Yu. V. Olefir, A. V. Nechaev, E. A. Khusnatdinova, A. K. Yakovlev
Rok vydání:	2020
Předmět:	Pharmacology Standard sample Chromatography biology 010405 organic chemistry Chemistry Pharmacology toxicology Antibody titer 01 natural sciences 0104 chemical sciences Human immunoglobulin 010404 medicinal & biomolecular chemistry Drug Discovery Blood plasma Anti-d antibody biology.protein Antibody
Zdroj:	Pharmaceutical Chemistry Journal. 54:325-328
ISSN:	1573-9031 0091-150X
DOI:	10.1007/s11094-020-02199-7
Popis:	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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_________::32866116814b7bdb829586cf03d251d2 https://doi.org/10.1007/s11094-020-02199-7 Zobrazit plný text záznamu Plný text ve formátu PDF Plný text ve formátu HTML
Nepřihlášeným uživatelům se plný text nezobrazuje	K zobrazení výsledku je třeba se přihlásit.