基因工程制药的优点 √大量生产过去难以获得的生理活性蛋白和多肽 (如胰岛素/细胞因子/疫菌抗原等) √发现、挖掘更多的内源性生理活性物质 √改造内源生理活性物质 √避免了血源性传染,克服了产品安全性问题 √创造自然界完全不存在的全新物质
微生物与生化药学教研室 基因工程制药的优点 ✓ 大量生产过去难以获得的生理活性蛋白和多肽 （如胰岛素/细胞因子/疫苗抗原等） ✓ 发现、挖掘更多的内源性生理活性物质 ✓ 改造内源生理活性物质 ✓ 避免了血源性传染，克服了产品安全性问题 ✓ 创造自然界完全不存在的全新物质
基因工程药物分类 基因工程治疗药物 cytokine:千扰素,白细胞介素,cFs,生长因子 hormone:胰岛素,生长激素,心钠素 enzyme:t-PA,尿激酶原,链激酶,葡激酶等 基因工程抗体和疫苗: antibody Vaccine 基因工程诊断试剂HIV诊断试剂盒 基因治疗药物:腺病毒P53
微生物与生化药学教研室 基因工程治疗药物 cytokine：干扰素，白细胞介素，CFS，生长因子 hormone：胰岛素，生长激素，心钠素 enzyme：t-PA，尿激酶原，链激酶，葡激酶等 基因工程抗体和疫苗： antibody vaccine 基因工程诊断试剂:HIV诊断试剂盒 基因治疗药物：腺病毒P53 基因工程药物分类
Some recombinant proteins used in clinical treatment Protein Clinical utility Coagulant factors Haemophilia A and B DNase i Cystic fibrosis Erythropoietin Anaemia in chronic renal disease Glucocerebrosidase Gaucher disease Growth hormone Nanism hypophyseal Insulin Diabetes Alpha interferon Some leukaemias, Kaposi's sarcoma hepatitis b and c Gamma-1b interferon Chronic granulomatous disease Interleukin-2,-3 and -4 Immunotherapy of cancer Tissue-type plasminogen activator Acute myocardial infarction, massive pulmonary embolism Antibodies for cellular immunotherapy Neoplasic processes Vaccines Influenza, hepatitis a and b Monoclonal antibodies Lupus, rheumatoid arthritis
微生物与生化药学教研室 Some recombinant proteins used in clinical treatment Protein Clinical utility Coagulant factors Haemophilia A and B DNase I Cystic fibrosis Erythropoietin Anaemia in chronic renal disease Glucocerebrosidase Gaucher disease Growth hormone Nanism hypophyseal Insulin Diabetes Alpha interferon Some leukaemias, Kaposi's sarcoma, hepatitis B and C Gamma-1b interferon Chronic granulomatous disease Interleukin-2, -3 and -4 Immunotherapy of cancer Tissue-type plasminogen activator Acute myocardial infarction, massive pulmonary embolism Antibodies for cellular immunotherapy Neoplasic processes Vaccines Influenza, hepatitis A and B Monoclonal antibodies Lupus, rheumatoid arthritis
Discovery (2-10 years) Preclinical (lab& animal) testing Phase 1(20-30 hea thy volunteers check for safety, dosage Phase ll(100-300 patient volunteers check for efficacy, side effects) Phase Ill(1000-1500 patient volunteers check long-run drug use FDA review approval Postmarketing testing 10121416 Ye Biotech drug discovery process
微生物与生化药学教研室 Biotech drug discovery process
二、基因工程制药基本环节
微生物与生化药学教研室 二、基因工程制药基本环节