Lonza and LFB sign antibody-manufacturing agreement
Swiss pharmaceutical firm Lonza and LFB of France are to collaborate on the manufacture of a monoclonal anti-RhD antibody developed by LFB. Under this agreement, the process developed by LFB will be transferred to Lonza, which will provide GMP manufacturing services for supporting the phase III clinical programme.
Swiss pharmaceutical firm Lonza and LFB of France are to collaborate on the manufacture of a monoclonal anti-RhD antibody developed by LFB. Under this agreement, the process developed by LFB will be transferred to Lonza, which will provide GMP manufacturing services for supporting the phase III clinical programme.
Lonza will also support LFB in its regulatory submissions by providing appropriate documentation. Financial details of the agreement were not disclosed.
The monoclonal anti-RhD antibody is used in case of rhesus incompatibility between a mother and her foetus. RhD-negative women who carry an RhD-positive foetus may produce antibodies to foetal RhD antigens. This new compound will ensure guarantee of supply as in this indication only plasma-derived therapies are available. The antibody, which is currently in phase I, will enter a phase II efficacy trial in the second half of 2009.
LFB is a French biopharmaceutical group that manufactures medicinal products for the treatment of serious and often rare diseases in several major therapeutic fields, including hemostasis, immunology and intensive care.
