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0605 | 抗体药物工艺开验证到商业化生产

时间: 05 月 23 日 08:30 - 10:00
内容介绍:

分会场主持人

朱向阳 博士

华奥泰生物医药有限公司总经理


随着越来越多的生物大分子药品结束三期临床试验,进入市场报批,大家对大分子的生产工艺开发和放大以及工艺验证,GMP生产,质量控制和法规的相关规定,都需要一个比较完整的理解。我们这个section主要是提供这样一种机会给大家,让大家从法规工艺验证以及新上

市的产品实例对这个过程有一个更深的认识。


抗体药物临床III期到BDL审批过程中工艺监管要点

讲者已邀请


生物制药生产工艺开发到商业化生产变革中的关键性因素

Raphael GRAETER

勃林格殷格翰工艺验证及质量负责人


“拓益”-国内首家上市PD-1单抗上市报批过程中工艺验证经验分享

冯辉 博士

君实生物首席运营官


日程嘉宾
2019 DIA中国年会/ 2019 DIA China Annual Meeting
朱向阳
华奥泰生物医药有限公司总经理
华奥泰生物制药公司,华博生物医药技术有限公司(华海制药)总经理朱向阳博士是拥有16年生物制药研发和工艺开发方面的专家。在单抗筛选和鉴定,双靶点抗体的工程改造,细胞株的建立,工艺开发, 技术转移, 中试厂房的设计和建设等领域拥有丰富经验。目前,朱向阳负责华海制药的全球生物制药研发。 加入华海制药之前,曾长期在勃林格殷格翰(BI)的不同领域和地点工作,领导和参与了30多个单抗或双靶点抗体项目的研究,其中包括目前临床二期和三期的项目。朱向阳是单抗rasankizumab的发明人和项目负责人 朱向阳在BI期间,还参与了多个生物产品的工艺开发,中试厂房的设计和建设。朱向阳获得伊利诺伊大学免疫学博士学位。朱向阳是“国家千人”特聘专家
2019 DIA中国年会/ 2019 DIA China Annual Meeting
Raphael Graeter
勃林格殷格翰工艺验证及质量负责人
Raphael Graeter is the Head of Process Validation at Boehringer Ingelheim Biopharmaceuticals (China) Ltd.in Shanghai, China. His responsibilities include establishing validation strategies, management, and guiding Boehringer Ingelheim’s direction for validation activities. Before moving to China, he was employed at Boehringer Ingelheim’s biggest mammalian production site in Germany, where he worked on several biopharmaceutical manufacturing processes as the Validation Manager. Initially, Raphael developed his validation, aseptic- and process operational skills at one of the word leading companies in their field, Vetter Pharma, being in charge of managing the production. He shared his knowledge with ambitious students at IHK Ulm, where he besides his professional career, worked as a free-lance lecturer for biotechnology. As graduate from University of Applied Sciences, Raphael holds a degree in pharmaceutical biotechnology. When not hard at work, doing process validation, he enjoys home brewing and traveling the East Asia region with visiting Chinas beautiful country sites.