THE MONOCLONAL ANTI-D IMMUNOGLOBULIN FOR PROPHYLAXIS OF HEMOLYTIC-DISEASE OF THE NEWBORN

Stable human-mouse heterohybridoma producing human monoclonal anti-D I gG1 has been derived by fusing Epstein-Barr virus (EBV) transformed hu man immune lymphocytes with mouse myeloma. The absence of EBV DNA in h eterhybridoma was demonstrated by the polimerase chain reaction. The a ntibody was purified by affinity chromatography on protein A Sepharose and tested for sterility, pyrogenicity and toxicity according to the Pharmacopoiea XI and the ability to clear from circulation RhoD-positi ve red cells. The time of clearance of sensitized RBC was about 3 hrs. Since it is believed to be an association between the rate of RBC cle arance by anti-D and the ability of the antibody to suppress the immun ization, the monoclonal immunoglobulin may prove suitable for immunopr ophylaxis of RhD hemolytic disease.