Lonza and LFB Enter Manufacturing Agreement
Lonza and LFB announced the signing of an agreement to manufacture 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 program. Lonza, with its successful regulatory track record, will also support LFB in its regulatory submissions by providing appropriate documentation. Financial details of the agreement are not being disclosed.
The monoclonal anti-RhD antibody is used in case of rhesus incompatibility between a mother and her fetus. RhD-negative women who carry a RhD-positive fetus may produce antibodies to fetal 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 phase II efficacy trial in the second half of 2009.
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Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous
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Topic world Antibodies
Antibodies are specialized molecules of our immune system that can specifically recognize and neutralize pathogens or foreign substances. Antibody research in biotech and pharma has recognized this natural defense potential and is working intensively to make it therapeutically useful. From monoclonal antibodies used against cancer or autoimmune diseases to antibody-drug conjugates that specifically transport drugs to disease cells - the possibilities are enormous