生物制药对医药厂房和设备仪器要求很高.PPT

Products of Biotechnology Main Contents Introduction The characteristics of the biotech products Techniques used to produce biotechnologic products The pharmaceutical concerns of biotech drug Products of Biotechnology The future of the biotech products Introduction The term biotechnology emcompasses any technique that uses living organisms in the production or modification of products. 生物技术或称生物工程（biotechnology),是应用生物体（包括微生物，动物细胞，植物细胞）或其组成部分（细胞器和酶），在最适条件下，生产有价值的产物或进行有益过程的技术。 Introduction Biotechnology has established itself as a mainstay in pharmaceutical research and development, and new products will enter the market at an increasing pace in the future. As of 2003, it was estimated that more than 370 biotechnology products were being developed by 144 companies and the National Cancer institute. 我国生物技术药物的发展 相比之下，截至目前，我国只有２０个生物技术药品投入市场，十余种生物技术新药正处于临床试验阶段，另有４０多种基因工程药物处于研发阶段。 与发达国家相比，我国生物技术实验室技术差距不大，但在产业化方面与世界的差距正在逐渐加大：当世界有２０多种畅销生物药时，我国能生产１０种；而现在世界上有１４０多种时，我国却只能生产２０多种。 生物技术药物的发展 通常，一个新药的开发生产，有55%的工时用于研发，10%用于销售，19%用于生产还有其它。 一个基因工程新药的开发费用平均需要1-3亿美元，并随新药开发难度的增加而增加(目前有的还高达6亿美元)。显然，雄厚的资金是生物制药开发成功的必要保障。 另外，生物制药对医药厂房和设备仪器要求很高，且属于一次性投入，这又需一大笔资金。 Introduction More than one-third of biotechnologic drugs in clinical trials are being tested for treatment of cancer; 29 products are under development for HIV infection, AIDS, and AIDS-related diseases. And 19 other biotechnologic drugs are in development for autoimmune diseases. They are all lifesavings! 表 已上市的部分常见生物技术药物 表 已上市的部分常见生物技术药物 Introduction The common forms of biotech drugs 1. Peptides or proteins (Human recombinants or monoclonal Antibodies) 2. Genes (DNA, RNA,siRNA) The characteristics of the biotech products 1．Biotech products are usually protein-based drugs 2．Mimic endogenous components with higher efficiency and lower side effects compare with small molecule drugs; 3．Intrinsic instability, multifaceted metabolic properties, and limited gastrointestinal absorption; Usually injections available 4．The biological