抗体药物开发暨工艺技术论坛---ATBP2018邀请函

近年来, 抗体药物及基于抗体的治疗药物已经逐步成为最重要的生物制品并且进入到黄金发展时期. 据粗略估计, 截止至2017年末, 美国药品监管单位已经批准上市了超过70种抗体药物. 与此同时, 生物制药作为国家新型战略产业之一,越来越多制药公司开始建立, 布局生物制品部门及产品管线.  同时在2015年国家食品药品监督管理局也相继发布了'关于生物类似药研发与评价技术指导原则' 进一步推动了生物医药行业的快速发展. 第二届抗体药物开发暨工艺技术论坛 , 将邀请60-70位在国内外有影响力的专家, 着重讨论 抗体及治疗性生物制品开发, 分析与工艺开发技术 .

The Antibody and Antibody-based Therapeutics have entered the center stage of drug discovery. Roughly, as of end of 2017, over 70 antibody therapeutics have been approved. Not only in Western Countries, there have been also considerable biologics R&D, manufacturing and commercial activities in Asia. In 2015, the China FDA also received the country's first biosimilar guidelines to establish the basic principles for development and technical evaluation of biosimilars towards the adoption of a more concrete and well-defined regulatory pathway. In return, the 2018 Antibody-based Therapeutics and BioProduction Forum is to build up and facilitate the communication and partnerships to accelerate Biologics R&D, Characterization and Production .

主办单位：

迪易咨询 Deliver Life Sciences

战略合作单位：

烟台迈百瑞国际生物医药有限公司

澳斯康生物制药（海门）有限公司

支持 单位：

美中药协费城协会 (SAPA-GP)

美中生物技术与制药协会 (SABPA)

抗体药物产品开发

抗体药物产品开发及行业发展趋势

抗体偶联药物研发, 分析及工艺技术

双特异性抗体, 创新及类似抗体药物开发

高通量技术及创新平台在抗体药物研发及工程中的应用

生物制品表征及分析技术

- Recent Trends and Development for Antibody Therapeutics

- The Development of Antibody Therapeutics in China

- Antibody-Drug Conjugates Development and Production

- Bispecific Antibodies and Similar/Novel Antibody Therapeutics

- Innovative Platform for Antibody Discovery and Engineering

- Biological Characterization Strategies

生物工艺开发

生物工艺开发创新技术

快速, 低成本临床试验样品制备策略

质量控制, cGMP生产及外包策略

生物制剂, 蛋白聚集及稳定性试验

细胞株及细胞培养工艺开发

连续工艺, 质量源于设计,过程分析技术与一次性系统

- Innovation in Biologics Manufacturing

- Integrated Strategies for Rapid Clinical Material Production

- Quality Control, cGMP Manufacturing and Externalization

- Biologics Formulation, Aggregation and Stability Studies

- Cell Culture Engineering and Downstream Processing

- Continuous Processing, QbD/PAT and Single-use Systems