Engineered monoclonal antibodies constitute the most rapidly growing class of human therapeutics, with over 20-years history. Since introduction in 1986 of CD3-specific muromonab (OKT3, murine), adverse human anti-mouse antibody (HAMA) immune reaction against the animal protein was one of the major obstacles to overcome. Human monoclonals can be obtained using several molecular biology approaches, including transgenic mice (HuMab-Mouse, Xenomouse), phage display, human hybridomas or immortalized human B-lymphocytes. From strictly of murine source (-momab), chimeric constructs (-ximab), humanized (-zumab) to recently entirely human (-mumab), this class of biological response modifiers represents now established and growing market of pharmaceuticals. Antibody drugs are expensive: large expense of drug development and high cost of manufacturing is a limitation despite an impressively high success rate in regulatory approval, about 25%, as compared with approximately 11% success rate for small-molecule drugs. In general antibodies are safe and well tolerated, limitations include infusion reactions, immunosuppressive-like adverse effects. Approximately 500 monoclonal antibodies are pre-clinical, about 160 are in clinical development and over two dozens (including the in vivo diagnostic monoclonals) are approved for human use. These include unmodified IgG molecules, Fab fragments, radioimmunoconjugates, antibody-drug conjugates.

*The article refers to the Polish edition of the author’s book (copyright Stefan Ball):  Zumaby terapeutyczne przeciwciała monoklonalne Ed. Wydawnictwo Medyk, Warszawa (2007), 111 pp.

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