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论文编号：	9717
作者编号：	2120152865
上传时间：	2017/12/9 11:17:35
中文题目：	S公司生物工程原料药开发项目的技术风险管理研究
英文题目：	Research on the Technology Risk Management of Bio Pharmaceutical Raw Material Development Project of S Company
指导老师：	戚安邦
中文关键字：	生物工程制药;乳腺生物反应器;项目风险管理;项目技术风险
英文关键字：	Biological engineering pharmacy;Mammary gland bioreactor;Project risk management;Project technological risk
中文摘要：	随着现代生物技术的飞速发展，生物制药产业越来越受到国际的普遍重视，世界各国都加大了对生物制药领域的产业投资，而生物技术的发展也带来了生物工程原料药市场的大举扩张。乳腺生物反应器制药是生产医药及功能性重组蛋白的新型方法，也是生物工程制药领域的重大突破，它将为制药行业带来新的机遇，具有巨大的经济和社会效益。由于高科技创新项目具有高风险的特点，特别是技术开发风险是所有项目风险中的重要因素，对研发项目的技术风险把控更是整个项目周期的重中之重，因而项目的技术风险评价和防范显得尤为重要。 本论文以S公司生物工程原料药开发项目为研究背景，综合运用项目管理、风险管理等多学科理论知识，就项目开发过程中的技术风险问题及影响因素进行系统综合分析。通过定性分析与定量研究相结合的方式，建立了技术风险因素指标体系、技术风险度量模型和技术风险应对方法。并在此基础上构建了企业生物工程原料药开发项目的技术风险预警、监控系统及运行方式，以对技术风险发生的全过程进行监督和控制，从而及时将威胁转化为机会，以减少和避免由于风险发生而给项目整体所带来的损失。本论文的研究成果，能够强化企业抗风险能力，提升企业的竞争优势，对丰富和完善企业生物工程原料药开发项目的技术风险管理研究有重要的理论价值和实践意义。
英文摘要：	With the rapid development of modern biotechnology, more and more attention has been paid to the biopharmaceutical industry, and all countries in the world have increased their investment in the field of biopharmaceutical industry.The development of biotechnology and biological engineering has also brought a massive expansion of raw materials market. Mammary gland bioreactor is a new carrier for producing medicine and functional recombinant protein. This method is also a major breakthrough in the field of bio engineering and pharmaceuticals, which will bring new opportunities for the pharmaceutical industry and have enormous economic and social benefits. The high risk of the high-tech innovation projects, which is an important factor in all project risks, makes the technical risk control for the overall project lifecycle more critical. Therefore, the technical risk assessment and prevention of the project is particularly important. This thesis takes the bio pharmaceutical raw material development project of S Company as the study case and have a systematic analysis of technical risk and its influencing factors in the process of project development through the comprehensive use of project management, risk management and other multidisciplinary theoretical knowledge. Index system of technical risk factors, technology risk measurement model and its countermeasures were established by combining the qualitative analysis with quantitative research. On this basis, the technical risk early warning system，technical risk monitoring system and its operation mode of the bio engineering raw material development project were constructed to supervise and control the whole process. In this way, threats can be translated into opportunities in a timely manner to reduce and avoid losses to the project as a result of the technical risk. The results of the research are helpful to strengthen the enterprise's ability to resist risks, promote its competitive advantage and have important theoretical value and practical significance to enrich and perfect the technical risk management of the bio engineering raw material development project.
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