重组人表皮生长因子原液车间工艺设计.docVIP

PAGE PAGE 27 重组人表皮生长因子原液车间工艺设计 摘 要 人表皮生长因子（hEGF）是一个小分子多肽，含有53个氨基酸，PI为4.6并且分子量约为6000Da。hEGF中通常有三对二硫键，所以对极端因素具有抗性。hEGF还有很多其他生物学功能，例如能够促进皮肤的生长、治疗各种创伤以及眼角膜的损伤都有很好的效果。EGF在化妆品行业的应用也很广泛，因为它可以起到美白去皱抗皮肤老化的作用。在20世纪80年代前，还没有对hEGF进行大规模工业化生产，主要生物提取，因此其纯度很低并且成本很高，20世纪80年代后科学家通过基因工程改造大肠杆菌、酵母菌等菌种，实现了hEGF工业化生产。因此，该设计的生产过程使用大肠杆菌作为宿主细菌，应用高密度发酵技术，并通过蛋白质纯化和其他技术大规模生产rhEGF储备液。 该设计结合了中国重组蛋白药物的实际情况。在查阅了许多文件和标准后，完成了工艺流程图和车间设计，计算了物料和热平衡，并进行了关键设备的设计和选择。 关键词：重组人表皮生长因子；高密度发酵工艺；车间设计 Process design of recombinant human epidermal growth factor stock solution workshop Abstract Human epidermal growth factor (hEGF) is a small molecular peptide composed of 53 amino acids, with a molecular weight of about 6000 Daltons and an isoelectric point of about 4.6. There are three pairs of disulfide bonds in the molecule, so it is physical, chemical, and acidic The factors are relatively stable. hEGF has a wide range of biological effects and can strongly promote the growth of various epidermal tissues. It has been used in medicine to treat burns, ulcers, various types of trauma, and corneal injuries. EGF can also promote the metabolism of normal epidermal cells. Adding it to beauty skin care products can achieve whitening, anti-wrinkle, and anti-aging effects. Before the 1980s, the source of hEGF was mainly through tissue and body fluid extraction. Due to the extremely small content of hEGF, the extraction cost was high and the purity of the product was low, which limited the application of hEGF. Since the 1980s, with the development of genetic engineering technology, people have achieved success in the production of hEGF through genetic recombination technology, using E. coli, yeast, etc., which has laid the foundation for the industrial production of genetically recombinant human epidermal growth factor. Therefore, the production process in this design uses E. coli as the host strain, applies high-density fermentation technology, and produces rhEGF stock solution on a large scale through protein puri