病毒风险降低策略研讨会

WORKSHOP ON VIRUS RISK MITIGATION STRATEGIES

会议主题

质量控制检测与生物制药病毒清除的重要性The  Importance of QC Testing and Virus Clearance for Biopharmaceutical Products

会议背景

生物制药产品需要保证无病毒和避免污染，近年来生物制药领域已经掌握并改进了已知病毒的污染率及检测方法，但仍面临新病毒所带来的挑战。本次研讨会将为生物医药领域提供一个互动交流机会，共同探讨病原体污染的风险降低策略，以及哺乳动物、鸟类和昆虫细胞源生物制品和血浆来源医药制品的病毒安全性质控检测方法。

主办单位：《中国生物工程杂志》China Biotechnology

            《病毒学报》Chinese Journal of Virology

支持单位：中国生物工程学会Chinese Society of Biotechnology

                 中国微生物学会  Chinese Society for Microbiology

会议时间：2014年10月21日下午14:00-17:00   Oct.21,2014 pm 14:00-17:00

会议地点：中国疾病预防控制中心病毒病预防控制所（北京市西城区迎新街100号）

                  National Institute for Viral Disease Control and Prevention, Chinese Centre for Disease Control and Prevention (100 Ying Xin Jie,Xicheng Qu,Beijing ,China)

会议内容

· 单克隆抗体生产中的病毒安全性  Virus safety consideration on MAbs production

· 生物制药产品的风险降低策略  Risk mitigation strategies for biopharmaceutical products

· 基于哺乳动物、鸟类和昆虫细胞系统所生产的产品的病毒风险  Virus risks for products produced in mammalian, avian and insect based cell systems

· 质量控制检测和病毒/朊病毒清除两种方法对于病毒/朊病毒风险降低的作用  What contribution to virus/prion risk reduction can be expected from effective sourcing, QC testing and virus/prion removal?

· 什么样的病毒质控检测可用于确保无病毒，以及该方法的局限性  What QC virus tests are available for ensure the absence of viruses and what are the limitations of such methodologies?

· 利用PCR方法检测病毒安全性  Use of  PCR testing for virus safety

· 将病原体出现的风险降到最低  Minimizing the risk from emerging pathogens

会议日程

14:00-14:05   主办单位致辞

14:05-14:15 病毒生物安全挑战与考虑   Virus safety consideration & challenges in China  报告人：武贵珍研究员，中国疾病预防控制中心病毒病预防控制所专家Professor WU Guizhen,  National Institute for Viral Disease Control and Prevention, Chinese Centre for Disease Control and Prevention

14:20-14:35 病毒生物安全与风险控制  Virus safety & risk control in China  韩俊研究员，中国疾病预防控制中心病毒病预防控制所专家  Professor HAN Jun,  National Institute for Viral Disease Control and Prevention, Chinese Centre for Disease Control and Prevention

14:35-14:55   Virus Risk Mitigation Importance & Strategies 报告人：Dr. Andy Bailey

14:55-15:10   茶歇

15:10-15:40   Virus clearance study; General concept, procedure and related regulations 报告人：Dr Ralf Klein

15:40-16:10   Cell banking and cell bank characterization (including Tumorigenicity and Oncogenicity testing)；General concept, procedure and related regulations 报告人：Dr Andy Bailey

16:10-16:30   Hot topic in pathogen safety testing and Case study for contamination case  报告人：Dr Ralf Klein and Dr Andy Bailey

16:30-17:00   讨论

会务咨询：

张宏翔研究员（中国生物工程学会，《中国生物工程杂志》），电话：13901251295，信箱：zhanghx@mail.las.ac.cn

王玉梅编审（中国疾病预防控制中心病毒病预防控制所，中国微生物学会，《病毒学报》），电话：8610-63537998，13521772305，信箱：wangyumei@bdxb.net.cn

Charles MY Lim，电话：18601672682，信箱：charlesmylim@gmail.com 

关于报告人

Dr Andy Bailey Dr Ralf Klein

Dr Andy Bailey（Austria）is an experienced  virologist/TSE expert, originally from Q-One Biotech (Glasgow) and actively involved in pathogen safety of biopharmaceuticals for almost 20 years.

· PhD at University of Glasgow followed by serving  9 years at the MRC Virology Unit in Glasgow

• Since 1995 Director of Virus Validation Services at Q-One Biotech, a leading company involved in virus and Prion bio safety testing of biopharmaceuticals

• Since 2000 Manager of the Pathogen Safety Group of Baxter Healthcare in Vienna, Austria

• Since 2005, CEO and founder of ViruSure in Vienna, Austria

• Andy is a well known expert recognized as invited speaker at expert workshops, including the MHA and EMEA (UK), FDA (USA), PEI (Germany), AFFSAPS (France) and JMHLW (Japan)

Dr. Ralf Klein（Germany）has been actively involved in pathogen safety of biopharmaceuticals for over 15 years.

• PhD at University of Heidelberg working on Hepatitis B Virus and Liver Cancer

• Since 1992 Research Scientist at Institute for Applied Tumour Virology at the German Cancer Research Centre in Heidelberg – patent on p53 ELISA

• Since 1993 Director PCR-Department at Diagnostic Laboratory Prof. Seelig, Karlsruhe, Germany

• Since 1997 Study Director Virus Validation Studies at BioReliance GmbH, Heidelberg, Germany

• Since 2000 Area Manager at BioReliance (later acquired by Invitrogen, by Avista and finally Sigma) for: Germany, Austria, Switzerland, Eastern Europe and India

• Since 2005 Head of European Sales at Newlab BioQuality GmbH (later  acquired  by Charles River Laboratories)

• Since 2009 Manager Business Development at ViruSure