Lonza is to carry out the GMP manufacture of a monoclonal anti-RhD antibody in development by LFB for treating rhesus incompatibility. Under the terms of the agreement, LFB has transferred its process for the antibody to Lonza, which will provide services for the Phase III program and also regulatory submission support.
The antibody is scheduled to start in Phase II trials during the second half of 2009; plasma-derived therapies are the only currently available treatments for the condition, according to LFB.
RhD haemolytic disease of the newborn is caused by maternal production of antibodies against the Rhesus D antigens on her baby's red blood cells. Of the various fetal-maternal alloimmunizations possible, RhD haemolytic disease of the newborn is the most common, LFB claims. In these cases the mother is anti-RhD but carries an RhD-positive child. Treatment to prevent the maternal production of antibodies against the fetal antigens involves injecting the mother with specific immunoglobulins.