Model essay on biopharmaceutical technology-analysis of biopharmaceutical technology
China library classification number R473.6 document identification number A1672-3783 (2011) 04-0344-02.
Modern biopharmaceutical technology is a high-tech closely combined with the pharmaceutical industry, which constantly provides new products and new dosage forms for the pharmaceutical industry, creating a brand-new road for the pharmaceutical industry, changing the face of the biopharmaceutical industry and providing the most promising way to solve human medical problems. This paper analyzes several biopharmaceutical technologies and their prospects.
Keywords biopharmaceutical technology
Brief introduction of biopharmaceutical technology
1 genetic engineering technology: hormones and various active factors are important substances that regulate human physiological metabolism and function, with strong activity and obvious clinical effect. However, these substances are very rare in nature, so it is difficult to extract them from human bodies and animals, and their sources are limited, which can not meet the clinical needs. However, modern biopharmaceutical technology provides cheap and efficient drugs for clinic. Insulin is a hormone drug for treating diabetes, which is usually extracted from animals. Its resources are scarce and expensive. After human or animal insulin synthesis genes are isolated by genetic engineering, they are transplanted into microbial cells to realize gene expression. The recombinant microorganism obtained by genetic engineering is called genetically engineered bacteria, which can produce 10g insulin in 200L fermentation irrigation, which is equivalent to the yield extracted from 450kg pancreas. Human growth hormone (HGH) is a protein hormone secreted by the anterior pituitary gland. It is composed of 19 1 amino acids with a molecular weight of 22000D d. In the past, human growth hormone could only be isolated and purified from the anterior pituitary gland, and its application was severely limited. At present, it can be obtained by genetic engineering technology and animal cell technology. Like human growth hormone, it can be used to treat dwarfism caused by HGH secretion disorder in the anterior pituitary, promote the recovery of traumatic tissues such as burns and fractures, and also improve the symptoms of senile renal atrophy and treat gastric ulcer.
Enzyme and cell immobilization technology: microbial transformation and enzyme catalysis technology have long been widely used in pharmaceutical industry. The combination of enzyme and immobilization technology makes up for the deficiency of enzyme, and has made remarkable progress in pharmaceutical industry, such as the production of 6-APA by Escherichia coli phthalate, hydrocortisone by ploughshare, glucose poisoning by lactic acid bacteria transforming sucrose, etc. The former BeohringerNannhein company in West Germany has made great progress in the immobilization of penicillin phthalase. They produced microsphere immobilized enzyme by polyacrylamide gel embedding method, and its surface activity was 100- 150 U/g, and 1 kg immobilized enzyme could produce 500kg6-APA, which could be continuously reacted for 300 times. They used the immobilized enzyme of the second generation engineering bacteria, the conversion rate reached 85%-90%, and the reaction times reached 900 times. Some people use immobilized enzyme to keep activity for more than 100 days. Immobilized cells, especially microbial cells, have been widely studied and applied in the synthesis of antibiotics, hormones, amino acids and other drugs. Many optically active compounds can be obtained by separating ibuprofen with immobilized enzyme membrane reactor. In vitro experiments show that the activity of its S- isomer is 100 times higher than that of its R- isomer. In recent years, the artificial kidney composed of various fixation systems can be transformed repeatedly in vivo, and the clinical effect is remarkable.
Cell Engineering and Monoclonal Antibodies: Plant cell engineering culture technology is of great significance to open up new drug resources, industrialize the production of microbial raw materials and protect the ecological balance of nature. In the clinical application of traditional Chinese medicine, there are thousands of Chinese herbal medicines, 89% of which are from plants. At first, wild resources were collected by hand. Finally, due to the limited wild resources, continuous development and utilization, it is difficult to meet the needs. Many precious medicinal materials, such as Gastrodia elata, Ginseng, Angelica sinensis, Huang Mao, etc., have adopted plant cells and large-scale culture technology, and contain more effective components than natural plants. For example, the content of ginsenoside in cultured ginseng cells is 5.7 times that of natural plants. The content of QIO in cultured tobacco cells is 65438 06.30 times higher than that in natural plants. Therefore, plant cell engineering will create a new generation of traditional Chinese medicine preparations for the benefit of mankind. Animal cell culture technology is mainly based on plant microorganisms, so it is difficult to produce protein drugs and realize industrialization and commercialization. The parent company in Velko, England, produced interferon A in an 8 cubic meter culture tank. As a typical example of industrialized animal cell culture, it was called "super-large-scale" animal cell culture and achieved success. 1975, British scientists produced hybridomas through the fusion of lymphocytes and bone marrow cells. After in vitro culture and isolation, some asexual cell lines can be obtained, which can secrete immunologically uniform antibodies. This antibody is a monoclonal antibody, which has shown great vitality in the world. In the medical field, because of its strong specificity and convenient operation, more and more monoclonal antibodies have replaced traditional antiserum for clinical diagnosis. After the United States approved the first monoclonal antibody diagnostic reagent in 198 1,1984 approved 37 kinds, and FDA approved 55 kinds in 1985. By the end of 1987, the United States had approved more than 100 monoclonal antibody diagnostic reagents, mainly because monoclonal antibodies have high specificity in binding with corresponding antigens. Some people tried to use antibodies against tumor antigens as carriers of anti-tumor drugs, so that anti-tumor drugs could selectively kill tumor cells without harming normal cells. This targeted drug consisting of monoclonal antibodies and anticancer drugs is called "biological missile".
Second, the application prospect of biotechnology
1 Increase R&D investment and establish an efficient R&D product line. Most small and medium-sized biomedical enterprises in China lack a perfect independent research and development system, and the efficiency of new product research and development is low. This is related to the serious shortage of R&D investment in domestic biomedical industry. At present, the proportion of R&D investment in sales revenue of most domestic biomedical enterprises is less than 65,438+00%, or even less than 2%, which is far lower than that of similar foreign enterprises. Insufficient investment in R&D often leads to poor follow-up product development. Domestic biomedical enterprises need to increase investment in R&D, establish or improve an efficient general technology platform from upstream construction, pilot scale-up, clinical research to final production, and provide a steady stream of new products for enterprise development. A few domestic enterprises, such as Shenyang Sansheng, spend 10% of their sales revenue on R&D every year. The company has developed a series of products such as interferon, IL-2, EPO and recombinant human thrombopoietin, with good operating performance.
The development of drugs expressed in mammalian cells is a great opportunity for the development of biomedicine in China. Most of the world's leading varieties adopt the technical platform of mammalian cell culture. At present, especially monoclonal antibody drugs have become an important development direction of biomedicine. In China, most leading products cannot be localized, often not because of patent restrictions, but because the technology platform is basically not mastered in China. It is expected that in the next few years, domestic enterprises that can really solve the important technical platform of efficient expression and large-scale culture of mammalian cells will get rich profit returns.
3. Choose suitable industrialization projects. The development of pharmaceutical products is risky. Even if the product is successfully developed, only about 3 out of every 10 new drugs can earn more than their R&D expenses, while the income of the other 7 new drugs is not enough to compensate their R&D expenses. Like other chemicals, most biomedical products have low profitability or even losses. Therefore, before the biomedical R&D project is established, it must be comprehensively demonstrated from both scientific and market aspects to reduce the risk of project R&D and marketing failure.
Biomedical industry is a promising industry. With the development of biomedicine such as "human genome", more and more biogenic drugs will be developed and put into production, and the biomedical industry will flourish.
refer to
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