Terapeutyczne przeciwciała monoklonalne i białka fuzyjne zawierające ich elementy
Therapeutic monoclonal antibodies and fusion proteins containing their elements. The fact that monoclonal antibody (Mab) can target a specific antigen among millions of potential antigens has tremendous therapeutic value. Until recently, two major limitations associated with Mabs hindered their commercial use: an inability to produce large quantities of antibody and the immunogenicity of the nonhuman component. Monoclonal antibody therapies have overcome their early hurdles and are now booming business area. Therapeutic monoclonal anibodies are the second wave of biotech products following recombinant proteins. To date 17 Mabs are approved by the FDA, 9 of them also by the EMEA. The first Mab therapies were overshadowed by disappointments of mousederived antibodies whose immunogenicity caused serious side-effects. Now, safer and more effective chimeric, humanized and fully-human antibodies are broadly reaching the market. Chimeric antibodies include Rituxan/MabThera (rituximab) and Remicade (infliximab). Humanized antibodies such as Avastin (bevacizumab) and Herceptin (trastuzumab), Synagis (palivizumab), Erbitux (cetuximab) are followed by the first fully human antibody Humira (adalimumab). Their main areas of therapeutic indications are: modulation of immune system activity, anticancer therapy, cardiovascular diseases and infectious diseases. Mabs are now the most common products in drug pipelines which currently comprises 132 Mabs in development with 16 approval candidates in the near future.