Quality control of immunoglobulins for intravenous administration.
Since there is as yet no official European pharmacopoeia or monograph for intravenously administrable immunoglobulins (IVIGs) and the manufacturers of IVIGs use different ACA methods to test their products until today, the study group 'Blood Plasma Constituents' of the DGTI carried out a multicenter study with six IVIGs from five manufacturers. The results of this first multicenter study have not been analysed statistically, because the participants have decided to carry out a second multicenter study using a uniform ACA method.
Kotitschke
R
R
Biotest Pharma Ltd., Dreieich.
Harbauer
G
G
D000818:Animals; D000936:Antigen-Antibody Complex / Q000032:analysis; D003169:Complement Inactivator Proteins / Q000032:analysis; D006461:Hemolysis / Q000276:immunology; D006801:Humans; D007116:Immunization, Passive / Q000379:methods / Q000592:standards*; D007074:Immunoglobulin G / Q000276:immunology; D007262:Infusions, Intravenous; D011489:Protein Denaturation / Q000276:immunology; D011786:Quality Control; D051381:Rats
D000936:Antigen-Antibody Complex; D003169:Complement Inactivator Proteins; D007074:Immunoglobulin G; C012749:anticomplement