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  • 生物药研发与包装选择

    1970/01/01 - 1970/01/01 协会


    时间/地点:2018年8月31日 下午 (Aug 31 PM) / 沃森报告厅(Watson Auditorium )

    内容介绍:

           与传统小分子药物不同,生化药物大多不能口服,而必须通过注射直接进入体内。相较迅速发展的生化药物开发,与之相匹配的注射装置(预充注射器(pre-filled syringe),自注射 器(auto-injector),自注射笔(auto-pen),可穿戴装备(wearable device))却未引起药物公司在早期足够的重视,研发明显滞后,妨碍了政府机构和病人关于个性化医疗、自我用药(self- administration)和安全注射的诸方面要求。我们的论坛将讨集中关注生物制剂和药包材的匹配性,生物药的密闭性研究,论药械组合产品方面的诸多问题和解决方案,预充注射器/自动注射器的选择和挑战,预充注射器研发中的常见问题,冷链运输以及美国药典关于玻璃材质的筛选标准。

    会议日程:



    本场设置中英同声传译


    演讲嘉宾:

      罗建军

      Overall 19 years working experience in formulation, process development, and

       aseptic manufacturing support upon receiving Ph.D. in Chemical Engineering 

       from Dalhousie University.Subject matter expert in sterile drug development, provide solutions on formulation, lyophilization, container/closure selection including pre-filled syringe and vial, fill/finish, process development via QbD, scale-up operation, tech transfer and manufacturing support. Developed 50+ drug formulations for more than 60 customers. The formulation includes biological liquids and lyophilized powders for IV, IM or SC injections, dermal gels, and lipid-based emulsion/liposome forms. Performed tox batch production, engineering run, and aseptic manufacturing support for 50 customers.



      Paolo Mangiagalli

      Sr. Director, Head PFS/Primary container platform,Sanofi.  Previously Dr  

      Mangiagalli had worked as R&D director in BD for 6 years. Dr Mangiagalli

      graduated from Université de Caen Normandie with PhD degree in Physics.



      Ronald Forster

      先后就职于美国默沙东(Merck)和安进(Amgen)制药公司,领导与生物制剂相关的包

      材团队,进行了一系列包材和药械组合产品的技术和工艺开发以及适配性稳定性研究,成功

      开辟了安进全球运输冷链。首次在美国上市COP(Cyclic Olefin Copolymer,环烯烃共聚物)塑料瓶和注射装置。Rutgers大学化学材料和机械工程博士,Rutgers大学生物医学工程和陶瓷工程学院客座教授。



      李磊 (Lei Li)

      Lei Li, Ph.D., is currently Senior Advisor at Eli Lilly and Company. He has been with

      Eli Lilly since 2009 in packaging development with a focus on container closure

      system design, characterization, and qualification. He obtained a Ph.D. in Analytical Chemistry from West Virginia University and worked as an analytical scientist at GE Plastics prior to joining Lilly.



      闻再庆

      负责药物分析和制剂研究,具有18年以上生物制药开发经验;发表研究论文60余篇,三次

      荣获美国PDA学会Frederick D. Simon奖;前美国Amgen主任研究员(Principal

      Scientist)和物化分析实验室主管。负责多个产品开发,分析和产业化生产,以及工艺流程开发和药品生产过程中的事故分析和质量管理,获多次Amgen公司杰出科学,技术,质量,合作奖;美国密苏里大学细胞生物和生物物理学研究讲师;日本文部省资深访问学者(JSPS)(日本蛋白质研究所);英国格拉斯哥大学化学系物理化学博士;中国科学院北京化学所助理研究员(高分子物理);中国科学技术大学化学物理学士。



      陈瑞潼

      陈博士拥有25年工业界和8年学术界经验,是应用科学诸领域的行家。在默克工作21年期

      间,卓有成效地带领团队进行一系列的项目开发如制剂,工序,产品稳定性,包材,医疗设

      备,数学建模,其中包括两年的药品生产经验。现今在安进领导冷链运输团队,成功地开辟了安进全球运输冷链。先前陈博士学士毕业于台湾大学,博士毕业于北卡州立大学,担任过北卡州立大学助理教授,专注于高分子材料及膜方面的研究。发表同行评议文章45篇,拥有制剂方面的多项创收专利。



      Michael N. Eakins

      Michael was Vice-Chair of the USP Packaging, Storage and Distribution Expert

      Committee in the 2005-2010 and 2010-2015 cycles and is currently a member of

      the USP Packaging and Distribution Expert Committee for the 2015-2020 cycle. He is an active member of the Parenteral Drug Association, being the co-chair of the Glass Defects Task Force that revised Technical Report 43 and was a member of the Elastomers and Seals Defects Task Force responsible for Technical Report 76 published in 2016. He obtained his Ph.D. from London University and has contributed to over 60 publications and 8 USA patents.






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