Prof. Wu Wutong
Dr. Huang Fengjie
College of Life Science and Technology, China Pharmaceutical University
Nanjing, China, 210009
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About the Authors:
Prof. Wu Wutong: Dr. Wu is Professor of Biochemistry and Molecular Biology, and Dean of the School of Biopharmaceutics (Pharmaceutical Sciences). He is advisor of Ph.D. degree candidates at the College of life science and technology, China Pharmaceutical University. He has been teaching and researching biotechnology and biopharmaceutics for more than 40 years. Dr. Wu has published over 300 papers and 14 special books and monographs, researched more than 10 new biological drugs (examples: Elastase, FDP, Recombinant asparaginase B and sHRF). Major concurrent jobs at the national level: Vice-Chairman of Special Committee of Biotechnology of the State Pharmaceutical Administration of China; Council Member of the National Gradentials Committee of Degree; Council Member of the Committee for Evaluating New Drugs in China; Editor in Chief of "Pharmaceutical Biotechnology"; Chairman of Jiangsu Province Society of Biochemistry and Molecular Biology. Honours: National Specialist of Brilliant Contribution of the Scientific and Technological Community; National Model Teacher; National Advanced Medical Worker of Science and Technology.
Dr. Huang Fengjie: College of life science and technology, China Pharmaceutical University. Education: She holds a Doctor of Biochemical Pharmacy Biochemical Pharmacy degree, China Pharmaceutical University; Master of Veterinary Medicine, Huazhong Agricultural University; B.Sc of Animal Husbandry, Huazhong Agricultural University. She teaches Microbiology and Biopharmaceutical Science at the college. Her major research activities focus on the areas of isolation and purification of natural products, drug action mechanism, and the pre-clinical study of new biological products. Dr. Huang was involved in various research projects funded by the China Hi-Tech Research and Development Program (863 Program) and National Natural Science Foundation of China. She is also the principal researcher for the pre-clinical study on the new drug sHRF. Dr. Huang has published more than 10 research papers in both Chinese and English journals, which include the Clinical and Experimental Pharmacology and Physiology, Journal of Pharmacy and Pharmacology and World Journal of Gastroenterology.
In this chapter, we discuss the technology systems associated with the Chinese biopharmaceutical industry and its development. Upstream biopharmaceutical technology in China has developed quickly. The gap in basic technology and laboratory research and development between China and developed countries is narrowing, with China behind approximately 5 years, while the gap in industrialization and commercialization is approximately 10-15 years wider, and not closing as rapidly.
The technology platform for research and development of protein-engineered drugs has been established in China for some time. This has played a pivotal role in the production of mutant IL-2 and tumor necrosis factor-_. As a result, China has achieved many successes in human genome research, transgenic animal research and industrialization, transgenic plant research, recombinant gene vaccine research. Important technological progress in the near future will be seen in the following: the fermentation technology of active ingredients of Chinese herbal medicines, manufacturing technology innovation of antibiotics, development of novel vaccines and diagnostic reagents, bioengineering manufacturing technology of amino acids, vitamins, organic acids, and steroid hormones, and the development technology of blood substitutes.
Analysis of the top 100 biopharmaceutical enterprises in terms of profits suggests that the total value of output and sales revenues of the Chinese biopharmaceutical industry is increasing faster than those of its other pharmaceutical industries. These indices show more than 15% annual growth for the Chinese biopharmaceutical industry. However, large-scale enterprises share 50% of production and sales, while 66% of Chinese biopharmaceutical enterprises remain small scale, suggesting that the overall scale of Chinese biopharmaceutical enterprises is small and the industrial structure is not well organized.
Large-scale manufacturing technologies adopted at Chinese biopharmaceutical enterprises involve primarily large-scale culture of animal, plant, and microbial cells, and separation and purification engineering of biochemical active substances. Accessory industrial equipment, such as large fermenters, air-compressors, high-speed centrifuges, and crater filter pressing devices can be made in China. However, high-grade bioreactors cannot be manufactured in China. Only medium- and low-grade technology products can be manufactured. In addition, most of these imitate foreign products. This indicates that large-scale production technology at Chinese biopharmaceutical enterprises is still lagging and requires improvement.