Potential approaches to prevent uncommon hemolytic side effects of AB0 antibodies in plasma derivatives.
Since hemolytic reactions in patients after administration of plasma derivatives like immunoglobulins or coagulation factor preparations have been described, titers of anti-A and anti-B-antibodies have to be below defined levels for batch release of these plasma-derived therapeutic products according to the European Pharmacopoeia. We have summarized clinical relevance of AB0 antibodies in plasma derivatives and related legal issues in the European Union, United States of America, and Japan. We have also discussed potential approaches for the prevention of hemolytic side effects with feasible steps in preparation of plasma derivatives, viz., (1) selection of donors, (2) exclusion of "dangerous donors", (3) optimizing ratio of the types of plasma, (4) removal of antibodies, (5) production of blood-group-specific plasma derivatives, (6) rejection of batches of plasma derivatives with high titers of antibodies, and (7) crossmatching before administration. For harmonization of standards for anti-A and anti-B in plasma-derived therapeutics the regulators and manufacturers will have to realistically deal with complex clinical, practical, and economic issues.
Buchta
Christoph
C
Department Transfusion Medicine, University Clinic for Blood Group Serology and Transfusion Medicine, Medical University of Vienna, Waehringer Guertel 18-20, A-1090 Vienna, Austria. christoph.buchta@meduniwien.ac.at
Macher
Maria
M
Höcker
Paul
P
D000017:ABO Blood-Group System; D000418:Albumins / Q000737:chemistry; D000743:Anemia, Hemolytic / Q000276:immunology* / Q000517:prevention & control*; D001771:Blood Banks; D001787:Blood Group Incompatibility / Q000097:blood*; D001788:Blood Grouping and Crossmatching; D005062:European Union; D005169:Factor VIII / Q000276:immunology; D006801:Humans; D007136:Immunoglobulins / Q000737:chemistry*; D016756:Immunoglobulins, Intravenous / Q000008:administration & dosage / Q000009:adverse effects*; D007518:Isoantibodies / Q000737:chemistry; D007564:Japan; D010949:Plasma / Q000276:immunology*; D013997:Time Factors; D014481:United States
D000017:ABO Blood-Group System; D000418:Albumins; D007136:Immunoglobulins; D016756:Immunoglobulins, Intravenous; D007518:Isoantibodies; D005169:Factor VIII