Plasma half-lives and bioavailability of human monoclonal Rh D antibodies BRAD-3 and BRAD-5 following intramuscular injection into Rh D-negative volunteers.
Two human MoAbs, BRAD-3 (an IgG3 anti-D) and BRAD-5 (an IgG1 anti-D), were produced from Epstein-Barr virus (EBV)-transformed B lymphoblastoid cell lines grown in hollow fibre bioreactors. Six Rh D-negative male volunteers were injected intramuscularly with anti-D; two received BRAD-3 (approx. 1500 micrograms, 2600 IU), two were given BRAD-5 (300 micrograms, 2000 IU), and two had polyclonal anti-D immunoglobulin (500 IU, approx. 100 micrograms anti-D). Levels of anti-D in plasma samples taken up to 42 days later were measured by a sensitive AutoAnalyser method. The half life of BRAD-5 (mean 22.2 days) was greater, and that of BRAD-3 (mean 10.2 days) less than that of polyclonal anti-D (mean 15.6 days). The bioavailability (plasma uptake) of the MoAbs (mean 33.9%) was less than that of the polyclonal anti-D (mean 60.3%). BRAD-3 and BRAD-5 may be suitable for use in antenatal and post-natal prophylaxis against Rh D haemolytic disease of the newborn.
Goodrick
J
J
South Western Regional Transfusion Centre, Bristol, UK.
Kumpel
B
B
Pamphilon
D
D
Fraser
I
I
Chapman
G
G
Dawes
B
B
Anstee
D
D
D000911:Antibodies, Monoclonal / Q000008:administration & dosage / Q000493:pharmacokinetics*; D001682:Biological Availability; D006207:Half-Life; D006801:Humans; D007074:Immunoglobulin G / Q000276:immunology; D007273:Injections, Intramuscular; D008297:Male; D012016:Reference Values; D012204:Rh-Hr Blood-Group System / Q000276:immunology*
D000911:Antibodies, Monoclonal; D007074:Immunoglobulin G; D012204:Rh-Hr Blood-Group System; C026410:Rho(D) antigen