In recent years, with the rapid iteration of biomedical technology, personalized treatment methods such as targeted drugs, immunotherapy, and gene therapy have become the main directions of biopharmaceutical innovation. Domestic companies have also advanced or transformed into the biopharmaceutical sector, and the biopharmaceutical market has become increasingly hot. Among them, the genetic editing baby incident has been listed in the "National" magazine's negative events in the 20th scientific breakthrough in 2018, but from the patent dispute a year ago, to the end of the year, the genetic editing company Editas human genetic editing clinical trial was approved by the FDA It can be seen that the development of gene editing technology is highly anticipated. Two major technologies PK As far as drug research and development is concerned, the most frequently used gene editing technology is the preparation of animal models. Since the homology of the immune checkpoint gene of the common mouse to the corresponding human gene is only about 60%, the antibody generally acting on the human protein does not recognize the protein in the mouse, and therefore it is impossible to use the ordinary mouse for the antibody drug. For the evaluation of drug efficacy, it is necessary to use a certain technology to convert the mouse gene as a gene target into a homologous gene of adult, that is, a humanized mouse to study a targeted drug, and let the mouse express human protein or antibody for use. Develop new treatments and drugs. Therefore, some industry experts expect that the demand for humanized animal models will continue to increase in 2019. At present, animal model gene editing technology can be divided into two categories: ES cell targeting technology and CRISPR/Cas9 technology. Among them, ES targeting is to carry out DNA homologous recombination in mouse embryonic stem cells (ES cells), re-injecting ES cells into the blastocyst cavity to form chimeric embryos, and developing chimeric mice in pseudopregnant mice. The chimeric mouse is then mated with wild type mice to transfer genetic information in the ES cells to the offspring mice. The advantage is that it is accurate and basically free of off-target, can carry out various complex genetic modification, is the industry gold standard; the disadvantage is inefficient, time-consuming, laborious, costly, and only applicable to mice. In recent years, some companies have made improvements. Han Lanqing, the chairman of Saiye Biotechnology, told reporters that the current version of the ES target improved TurboKnockout technology has shortened the construction cycle from one year to half a year and almost the same as CRISPR, and the cost has also decreased. At present, the most popular and widely used CRISPR/Cas9 system is composed of Cas9 protein and guide RNA. Cas9 contains two active sites, RuvC at the amino terminus and HNH at the middle of the protein, which play a role in crRNA maturation and double-strand DNA splicing, causing DNA double-strand breaks. When the DNA is broken and a DNA fragment homologous to the damaged DNA is present in the nucleus, the foreign DNA fragment can be introduced at the destination site by homologous-mediated double-stranded DNA repair, thereby achieving the effect of fragment knocking or editing. The advantages are efficient, fast, simple, inexpensive, and can be used in different species; the disadvantage is that there is always an unpredictable and uncontrollable off-target risk, and it is not suitable for complex genetic modification projects. For CRISPR technology, some researchers have pointed out that the current off-target problem can not be completely avoided. “Although off-target prediction and a certain degree of prevention can be performed through genome-wide off-target risk calculations, scientific research with very high rigor is still to answer the question of off-target.†In addition, the researchers also reminded that there are still intellectual property disputes at CRISPR, which may adversely affect the subsequent commercialization of the research. Can the resource pool reduce costs? The patented patent technology requires an authorization fee, while the ES target is relatively high in both time cost and cost. Therefore, how to obtain high-quality animal model services at a lower cost has become a concern of many research institutions. Han Lanqing believes that it is a good consideration to build a resource library from a professional gene knockout model animal commercial technology platform or related machine to make part of the service product. “The continuously optimized cryopreservation technology can further improve the recovery rate and birth rate of sperm and embryos in animals, and has ideal stability, which provides stable technical support for the construction of gene knockout mouse resource pool.†According to the reporter At present, many domestic model animal suppliers are building their own resource pools. For researchers, the same strains, the cost of custom animal models is also significantly higher than the purchase of commercial institutions, especially in the study of Me-too, Me-better drugs. In addition to domestic suppliers, overseas model animal customization and breeding service businesses are also targeting the Chinese market. Han Lanqing revealed that the strategic cooperation between Saiye Biotechnology and Taconic Biosciences will be officially launched on January 1, 2019. “There will be a comprehensive model of animal customization and reproduction for the global life sciences and pharmaceutical industry in the form of alliances. One-stop service. The industry can provide services to European and American institutions more conveniently through Taconic. Taconic can introduce more than 4,000 lines to researchers in China and Asia Pacific through the industry." It is conceivable that with the output of more high-quality animal models, the pace of accelerated biomedical research in China will be more stable and bring more new biopharmaceuticals to the world. 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