BiologicsProcessDevelopmentandManufacturingOpportunitiesandChallenges
发布时间 :2013-11-07  阅读次数 :2047
 

报告题目:Biologics Process Development and Manufacturing Opportunities and Challenges

报 告  人:Dr. Weichang Zhou

2013年被选为美国化学学会(ACS)终身会士(ACS Fellow)

2002年被选为美国医学与生物工程院(AIMBE)院士(Fellow)

报告时间:11月11日,上午10:30

报告地点:闵行校区生物药学楼2#116

联 系  人:钟建江    021-34206968

简介:

周伟昌博士于1989年获得德国汉诺威大学化学工程专业博士学位。 1989至1994年期间先后在德国化工技术与生物工程协会研究院,瑞士苏黎世联邦理工大学生物技术研究院和美国明尼苏达大学生化工程领域做博士后研究工作。在美国生物制药行业从事了20多年治疗性蛋白,单抗和病毒疫苗生产工艺的开发和大规模产业化方面的管理工作,同时直接参与十多种生物制药的研发,申报和大规模生产。先后担任美国默克公司研发部生物工艺部门发酵和细胞培养部副总监,美国PDL生物制药公司工艺科学和工程部高级总监,美国健赞公司(赛诺菲公司的一部分)商用细胞培养工艺开发部高级总监。于2012年12月回国加入药明康德,担任生物制药和生物工艺开发副总裁。

摘要:

Biologics which are large molecule biopharmaceuticals produced by living cells include recombinant DNA-derived proteins and monoclonal antibodies. They are increasingly used to treat a broad range of diseases, especially in the fields of rheumatology and oncology, as well as cardiology, dermatology, gastroenterology and neurology. Global sales of biologics reached US$125 billion dollars in 2012, among which sales of monoclonal antibodies and antibody fusion proteins were US$65 billion dollars.  However, only a few biologics drugs are currently available in China, despite the increasing demand from Chinese patients. The total biologics sales in China were less than 3% of the global sales in 2012.  Therefore, opportunities and challenges are different for biologics process development and manufacturing globally and in China.  Nonetheless, there are increasing needs for speed, improved productivity and quality, low costs and flexibility.  Beyond accelerated timeline and process intensification for higher productivities, many efforts nowadays focus on development and design of flexible and cost effective processes and manufacturing facilities using small-sized and disposable bioreactors.