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Stability of European Anti‐D Immunoglobulin Preparations
Author(s) -
Suomela Hannu
Publication year - 1991
Publication title -
vox sanguinis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.68
H-Index - 83
eISSN - 1423-0410
pISSN - 0042-9007
DOI - 10.1111/j.1423-0410.1991.tb00877.x
Subject(s) - chemistry , plasmin , incubation , chromatography , antibody , lysozyme , enzyme , plasminogen activator , prekallikrein , albumin , thermolabile , biochemistry , microbiology and biotechnology , immunology , endocrinology , kallikrein , biology
. The stability of 18 batches of anti‐D immunoglobulin preparations from 7 European manufacturers was studied over 28‐day incubation at +37°C and 3‐year storage at +4°C. The mean loss of activity after 28 days at +37°C was 12.3 ± 8.2%, and after 3 years at +4°C 15.2 ± 9.5%. The correlation coefficient of the loss of activity between these two storages was r = 0.61, p < 0.05 indicating that short‐term incubation can be used to evaluate the shelf life stability of anti‐D activity. In general, measurements of IgG fragments or activities of plasmin, plasminogen, or prekallikrein activator were not valuable in predicting the stability of anti‐D activity due to the fact that the preparation of each manufacturer has its own unique pattern of enzymes and inhibitors. The anti‐D immunoglobulin preparations contained up to at least 7 plasma proteins in addition to IgG. All preparations contained factor B, most of them α 2 ‐macroglobulin, α 1 ‐antitrypsin, albumin, and α 2 ‐HS glycoprotein. α‐Lysozyme was present in 7, and ceruloplasmin in 2 preparations. Neither purity nor impurity correlated with stability.