With the continuous development of monoclonal antibody technology and the emergence of new antibodies, monoclonal antibody drugs has become one of the fastest growing areas of in the pharmaceutical industry. Currently, a quarter of the biotechnology drugs under researching are monoclonal antibody drugs. At the same time, various derivatives of monoclonal antibodies are emerged, including antibody drug conjugate, small molecule antibody, bispecific antibodies, etc.
The Biopharmaceutical industry consists of biotechnology industry and pharmaceutical industry. It is now focusing on the development of monoclonal antibody cloning drugs, protein drugs, genes and nucleic acid drugs and so on. Good policy will promote the rapid development of this industry.
The Processes and Trends of the R&D of Monoclonal Antibodies
In general, a mAb enterprise needs advanced research and development platform to screen out ideal mAb drugs. It also needs efficient large-scale fermentation to express mAbs and the ability to isolate purified mAbs efficiently. Only such companies are possessed with core competence in mAb R&D and manufacturing.
Phage display technology has become the mainstream of human monoclonal antibody screening. With the further development of mAb humanization, phage display technology-centered (Amplify the entire antibody heavy chain variable region (VH) and light chain variable region (VL) genes with PCR technology, and clone them onto the phage vector and express on its shell surface in the form of fusion protein) large-scale monoclonal antibody screening platform has become increasingly critical.
The technology can not only obtain fully human antibody, but need no cell fusion as well. With short test cycle and simple processes, it is a significant breakthrough of human antibody preparation technology. At present, international mainstream monoclonal antibody manufacturers are using phage display technology in screening monoclonal antibodies.
Expressing the culture method is the key control of the yield and quality of mAbs. The expression method, reactor scale, expression system and expression quantity are all important indexes to judge the technical level of an enterprise.
Isolation and purification technology are the last key processes in the manufaturing of monoclonal antibodies. Ammonium sulfate precipitation, ion exchange chromatography, protein-sepharose affinity chromatography are commonly used to purify mAbs. As the yield of products will be reduced by 13% while per purification step is added, ensuring the purity while increasing the productivity is also an important way to measure the production level of an enterprise.
The Characteristics of the R&D of Monoclonal Antibodies
Monoclonal antibody R&D is characterized by high input, high price as well as high profits. Its R&D cycle can be as long as 10-15 years. Once open to the market, it can bring substantial profits to the manufacturer. The cost of arge-scale antibody production is about 200 US dollars/g, while the price is 5,000 US dollars/g, which is only 1/25 of the cost. In 2016, $25 billion-worth monoclonal antibody patent expired, following by the era of antibody drug generics.
The Trends of the R&D of Monoclonal Antibodies
The proportion of monoclonal antibody has been increasing, and the drug target of monoclonal antibody has been gradually diversified. In addition to the traditional cell surface antigens, common cytokines are included. Some monoclonal antibodies can even recognize multiple epitopes , and the structure of the monoclonal antibody is not limited to the complete monoclonal antibody. Combined with the growing of treatment programs like small molecules, it is increasingly valued by medical workers. Therefore, as a high-tech drug, the scientific and technological level of a monoclonal antibody enterprise determines its competitiveness, and also the therapeutic effects and market value of its drugs.