In the 21st century, biotechnology, together with information technology, will provide a powerful driving force for global economic development and "become the most important technology for the whole society and may change the future industrial and economic pattern." Antibody engineering technology has been continuously improved with the development of modern biotechnology, and is the main force in biotechnology industrialization, especially in the field of biotechnology pharmaceuticals. As of the end of 2000, there were 76 types of biotech drugs on the U.S. drug market, including 15 antibody drugs; among 369 biotech drugs in the clinical research stage, 70 were antibody drugs. Since my country implemented the "National High Technology Research and Development (863) Plan" in 1986, the research and development of biotechnology have made great progress, and the antibody engineering project has always received key support from the "863" plan and already has A certain scientific research foundation and good development momentum of industrialization have emerged. Development History of Antibody Engineering Antibodies have been used as preparations for disease prevention, diagnosis and treatment for hundreds of years. The early method of preparing antibodies was to immunize animals with a certain natural antigen through various ways. After the mature B cell clones are stimulated by the antigen, they secrete the antibodies into the serum and body fluids. In fact, the antibodies in the serum are a mixture of multiple monoclonal antibodies, so they are called polyclonal antibodies. Polyclonal antibodies are the first step in the purposeful use of antibodies by humans. The heterogeneity of polyclonal antibodies limits further research and application on the structure and function of antibodies. In 1975, Kohler and Milstein used B lymphocyte hybridoma technology to prepare homogeneous monoclonal antibodies for the first time. Hybridoma monoclonal antibodies are also called cell-engineered antibodies. The birth of hybridoma technology is considered to be the first qualitative leap in the development of antibody engineering and a milestone in the development of modern biotechnology. Monoclonal antibodies prepared using this technology are widely used in disease diagnosis, treatment and scientific research. This kind of monoclonal antibody is mostly secreted by hybridoma cells formed by cell fusion of mouse B cells and mouse myeloma cells. It is of mouse origin and will cause rejection of the body when entering the human body. The molecular weight of the complete antibody molecule is relatively large. The ability to penetrate blood vessels in the body is poor; the production cost is too high and is not suitable for large-scale industrial production. In the early 1980s, the research results on the structure and function of antibody genes were combined with recombinant DNA technology to produce genetically engineered antibody technology. Genetically engineered antibodies are antibody molecules whose genes are processed, modified and reassembled according to different needs, and then introduced into appropriate receptor cells for expression.
Compared with monoclonal antibodies, genetically engineered antibodies have the following advantages:
1. Through the modification of genetic engineering technology, the body's rejection response to antibodies can be reduced or even eliminated;
2. The molecular weight of genetically engineered antibodies is smaller, which can partially reduce the mouse origin of the antibodies and is more conducive to penetrating the blood vessel wall and entering the core of the lesion; 3. Prepare new antibodies according to treatment needs;
4. Various expression methods such as prokaryotic cells, eukaryotic cells and plants can be used to express antibody molecules in large quantities, greatly reducing production costs.