Text / Chai Yan
    Monoclonal antibody (McAb) the earliest produced in the eighties of the 20th century, 1999 global monoclonal antibody drug market sales of only $1.2 billion, 2002 has reached 40 billion, in 2004 global sales of about $103 billion, in 2007 the market size has exceeded the $221 billion. Among the world's top selling biopharmaceutical 10, monoclonal antibody drugs accounted for 6 seats. Expected in 2010, global sales of monoclonal antibody drugs is expected to reach $30 billion. Monoclonal antibody market is one of the fastest growing and most profitable markets in the pharmaceutical industry.
    Monoclonal antibodies are produced in response to specific antigen specific antibody purification. It has high specificity, can accurately aim, target capture, specifically for the target reaction. Therefore, it is called "biological missile". At present, China's food and Drug Administration approved a total of 13 monoclonal antibody drug listing, 7 are imported drugs, 6 are China's R & D, including 3 national biological products, a class of new drugs, are anticancer drugs. In addition, 6 of the 3 products in the country is the source of the rat, 1 block and type, 2 individual monoclonal antibody.
    In the 1990s, when he was Secretary of State Science and Technology Commission for social development, deputy director of the division of Bai Xianhong has repeatedly led a delegation to visit Cuba, the Cuban biotechnology produced a profound impression. In 2000, Bai Xianhong introduced a new drug, which was developed by Cuba, to clone and humanized anti human epidermal growth factor receptor monoclonal antibody. At that time the company registered capital of 60 million yuan, the Cuban side of technology shares, and then in 2005, an additional funding.
To overcome the technical difficulties of human resources
    In the process of cooperative research and development, production of monoclonal antibody drugs, one hundred Thai face two major technical difficulties, one is the humanized antibody technology, the two is the size of the mammalian cell culture.
    Because the cell antibody in mice culture and extraction, so early monoclonal antibody drugs are murine McAbs, such drug specificity is very strong, but also often cause the body's immune response, side effects obvious. Therefore, the second generation of chimeric monoclonal antibody drug on the surface of the amino acid residues in the mouse antibody surface transformation, the degree of human source reached about 70%. Third generation of humanized monoclonal antibody to the degree of about 95%, making it more close to the human body's own antibodies. Nowadays, the fourth generation of the foreign countries have been the source of the technology.
    The difficulty of humanized technology is that it requires a lot of discipline integration, very complex and change any amino acid will affect the protein structure and activity, this not too many norms can be followed. Therefore, it is necessary to a great deal of practice and research. This is the core technology of monoclonal antibody drug research and development." He also pointed out that, from the safety, efficacy and price point of view, and to consider the cost of input, output time, technical level and other factors, the current source of antibodies have been able to basically meet the domestic market.
    Due to Cuba in the field of antibodies, vaccines and other areas of technical research leading, 100 Thai people in the source of technology through cooperation in 3 years will be a breakthrough. In 2002 hundreds of Thai students took out of sample test, began to enter the clinical.
Mammalian cell culture programs are subject to national attention
    From 2002 to 2005, took completed phase I clinical stage II nasopharyngeal carcinoma, to get a new drug certificate. Originally intended to get the same year GMP certification, officially put into operation, but only to the new plant construction delays more than a year, making it until the end of 2006 a full set of production equipment to debug, installation completed. Then, in 2008, one hundred Thai took more than 1 years of research on the scale of mammalian cell culture technology.
    "From the mammalian cell culture is a very big problem, as has been the a corn seed, but to cultivate a cornfield difficulty is very great, this is the key to the industrialization of the production of where." Bai Xianhong said. At present there are two main kinds of cell culture technology in the world, one is called "batch", one is called "flow" ". Batch technology needs large-scale biological reactor, the initial investment is very large, and irrigation technology through recycling, can reduce some of the initial cost.