Received September 9, 2013
The prophylaxis of the hemolytic disease of the newborn – a mandatory procedure in obstetrics – requires significant amounts of plasma-derived polyclonal anti-D immunoglobulin. Despite numerous attempts, the proper technology for mass production of effective monoclonal anti-D is still not available. LFB Biotechnologies is currently performing clinical trials with recombinant anti-D antibody that has low fucose content and is expressed in the cells of rat myeloma YB2/0. It was shown that this drug is well tolerated, accelerates fast clearance of D+ red blood cells, and can inhibit anti-D immune response in Rhesus-negative volunteers.
KEY WORDS: anti-D monoclonal antibodies, Roledumab, glycosylation, alloimmunization, clinical trials