Dr. Li Guorong has more than 30 years of experience in biopharmaceutical and production profit assessment in the United states. At present,He is the Vice President of Sino-US joint venture Huaxing Biotechnology Company. Huaxing's PAT-based online dispensing process can meet the regulatory requirements for buffer QbD and validation.

Michael Li 学历和工作简历

1985, 美国夏威夷大学博士学位, 海洋生物药

1987-1990 Moana BioProducts, extracted and sold marine toxins to pharmaceutical companies for cancer and AIDS research

1988,美国化学学会夏威夷分会总裁

2010 &2011, Member of the Industrial Advisory Committee, Preparative Chromatography, USA, 美国层析产业筹备咨询委员会成员

11/2011 苏州工业园区“领军人才”

5/2012, Vaccine疫苗期刊邀请去编写疫苗下游纯化技术

30年蛋白药层析工艺开发经验, collaboration with 许多**生物制药公司如Amgen, Abbott, Chiron and Immunex 

文章发表

Li, M, 蔡月红, 杨瑛, “Effects of pumps on Protein Biological Activity”,弗戈流程工业,2014,10期,page 68-69 

Li, M., 蔡月红, “树立QbD理念, 应用PAT技术提高生物制药效率”, Vogel Process,弗戈流程工业, 2014,5期,page 52-54

Li, M. “A review of downstream bioprocessing of vaccine products”, Vaccine, (31), 2013, Pg 1264-1267

Li, M. “PAT-based In-Line Buffer Dilution in Downstream Bioprocessing, PharmaTech Supplement”,  October 2010

Li, M., Davis, W., cGMP Commercial Scale Oligonucleotide Synthesis and LC Purification, Chemistry Today (Chimica Oggi), page 50-56, March, 2010

Li, M., PAT-based in-line Buffer Preparation in Plasma Fractionation Process, IFPA, January 2011

Li, M., The Benefits of PAT-based Buffer Preparation in Production Scale Bioprocess, Recovery of Biologics, August, 2010

讲课

03/2015, 树立Quality by Design (QbD)理念, 应用Process Analytical Technology (PAT) 技术提高生物制药效率, 第五届中国仿制药峰会, Shanghai, China   

06/2013   中国医学装备协会生物工程装备技术专业委员会, 血制品纯化工艺, 贵阳血制品      

05/2013 弗戈制药工程, “应用PAT技术提高生产效率” Vogel Process, Beijing  

10/2012 用PAT-based技术去优化血制品, 华兰生物, 新乡, 诃南, 

9/2012 笫14期蛋白质分离纯化技术专题, 中国生物工程, 上海

08/2012   纯化蛋白药技术, 苏州科技学院, 化学与生物工程学院

03/2012   智能生物泵优化生物活性,Vaccine and monoclonal antibody conference, 北京

10/2011   蛋白大分子药物纯化工艺优化策略,多肽及蛋白质药物研发与技术创新发展研讨会, 北京