Research progress of therapeutic monoclonal antibodies and key technologies of antibody industry Antibodies, as effector molecules of the body's immune response, can recognize, neutralize, or eliminate disease-causing antigens. The "variable region" (Fab) of an antibody can specifically bind antigen or target cells; the "constant region" (Fc) of an antibody mediates a variety of cell-effect functions (CDC, ADCC, etc.). In addition, the binding of the Fc end to FcRn makes the half-life of antibody molecules in the body up to ten to twenty days. The molecular structure and biological functions of the above antibodies ensure their medicinal efficacy as therapeutic eggs. By the end of 2012, a total of more than 30 kinds of therapeutic antibodies had been put on sale in the European and American markets (see Figure 1). The above antibody drugs have achieved great success in the treatment of immune diseases [1] and cancer [2]. Judging from the research and development line of antibody drugs, more than three hundred monoclonal antibodies have entered the clinical research stage [3]. The success rate of antibody drug development (20%) is much higher than that of traditional small molecule chemical drugs (11%) [4]. Therefore, antibody drugs have become, and will continue to be the main direction of the development of the pharmaceutical industry in the future [5]. 1 Development process of antibody technology The therapeutic application of antibodies in clinics began in 1888 when Emile Roux used "polyclonal antibodies" to cure patients with diphtheria. In 1897, Paul Ehrlichs proposed the "magic bullet" (magic bullet) hypothesis: the use of antibodies for "targeted therapy." Immunizing animals with antigens can quickly obtain "antisera" containing polyclonal antibodies. However, since polyclonal antibodies are essentially mixtures of monoclonal antibodies directed against different epitopes of the antigen, their quality is not uniform, and due to the limitations of the preparation route of immunized animals, the clinical application of polyclonal antibodies is rare; last century In the 1970s, using mouse B-lymphoid hybridoma cells, it was possible to obtain "monoclonal antibodies" against a single epitope. The latter have more cloned antibodies with high specificity, good uniformity, and low cost. They are clinical applications of antibody technology. Bring a breakthrough [6]. In the 1980s, American Gentech applied for the first patent on the preparation of "recombinant antibody" ("Cabilly patent" patent), that is, the use of DNA recombination technology to introduce antibody heavy chain and light chain DNA into host cells at the same time. Synthesis and secretion of biologically active monoclonal antibodies. Since then, the production of therapeutic antibodies has really entered the stage of industrialization. In addition, genetically engineered antibodies can cut, splice, and assemble antibody molecules at the genetic level, conferring new biological activity on antibody molecules, and have more application prospects than "polyclonal antibodies" and "hybridoma monoclonal antibodies". 1.2 Development process of antibody drugs In 1986, the "murine monoclonal antibody" OKT3TM (muromonab) produced using hybridoma technology became the first therapeutic monoclonal antibody on the market. However, due to the serious immunogenicity (human anti-mouse anti) of mouse monoclonal antibody. The clinical application of antibody drugs in the first ten years on the market is not widespread. Since then, the "chimeric antibody" technology retains the murine Fab and replaces the murine Fc end with a human Fc segment, which partially reduces the immunogenicity of the murine antibody. "CDR grafting technology" can also replace part of the variable region sequence with human sequences to further reduce the immunogenicity of chimeric antibodies. Antibody drugs using this technology are called "humanized antibodies. Due to the successful reduction of the immunogenicity of recombinant antibodies, many chimeric antibodies and humanized antibodies that were launched in the late 1990s have been widely used in clinical practice. Leather Sectional Sofa,Synthetic Leather Sofas,Office Sectional Sofa,Sythetic Leather Sofa Set Kaifeng Lanwei Smart Home Co., Ltd , https://www.sofa-recliner.com