報告題目:Biologics Process Development and Manufacturing Opportunities and Challenges
報 告 人❄️:Dr. Weichang Zhou
2013年被選為美國化學學會(ACS)終身會士(ACS Fellow)
2002年被選為美國醫學與生物工程院(AIMBE)院士(Fellow)
報告時間:11月11日,上午10:30
報告地點:閔行校區生物藥學樓2#116
聯 系 人:鐘建江 021-34206968
簡介:
周偉昌博士於1989年獲得德國漢諾威大學化學工程專業博士學位。 1989至1994年期間先後在德國化工技術與生物工程協會研究院,瑞士蘇黎世聯邦理工大學生物技術研究院和美國明尼蘇達大學生化工程領域做博士後研究工作🦹🏽♂️。在美國生物製藥行業從事了20多年治療性蛋白🌔,單抗和病毒疫苗生產工藝的開發和大規模產業化方面的管理工作⛹🏿♀️,同時直接參與十多種生物製藥的研發,申報和大規模生產。先後擔任美國默克公司研發部生物工藝部門發酵和細胞培養部副總監,美國PDL生物製藥公司工藝科學和工程部高級總監,美國健贊公司(賽諾菲公司的一部分)商用細胞培養工藝開發部高級總監。於2012年12月回國加入藥明康德,擔任生物製藥和生物工藝開發副總裁。
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.