Informa

Well Characterized Biologicals & Biological Assays
-生物制剂与生物试验的特性评估年会-
日期:2018年10月24-26日
地点:美国马里兰州罗克维尔,Hilton Washington DC/Rockville Hotel & Executive Meeting Center

透过特性评估策略与CMC生物试验发展的最佳化,确保CMC的成功并加速产品的上市

从个案研究、与法规机构干部交换意见、未来展望得到实际建议,以及可以加速生物计画的新兴技术

Choose your language
Chinese
Japanese
Korean
English

Cross-Fertilize Ideas and Discuss Common Challenges with CMC, Analytical, and Biological Assay Colleagues

Track 1: Modality Specific Characterization & Strategies for Diverse Products
  • Analytical Methods for ADCs, Bispecifics and Fusion Proteins
  • New Modalities
  • Protein Characterization & Product Comparability
  • Biosimilar Comparability & Interchangeability
  • Stability Studies
  • Specification Setting
Track 2: Areas & Applications of Characterization
  • Host Cell Proteins
  • Process and Product Variants and Impurities
  • Higher Order Structure
  • Upstream and PAT
  • Breakthrough Therapy Designation
  • Immunogenicity
Track 3: Improving Biological Assay Development and Validation for Platform and Emerging Modalities
  • Are the Guidelines Aspirational?
  • Lifecycle Approaches and Strategies for Bioassay Development
  • Applying DOE and QbD to Bioassay Development
  • Developing Bioassays for Biosimilars 
  • Bioassay Development for Complex Molecules & Cell Therapies
  • Monitoring Performance, Controls, and Reference Management Programs for Bioassays
  • CMC Biological Assay Case Studies
  • Potency Assays - Automation, Statistics, and Critical Reagents

More attendees, additional speakers, more posters, extra networking!

Learn about regulatory expectations from the source by meeting with multiple FDA reviewers
  • FDA Town Hall with Alfred Del Grosso & Lokesh Bhattacharyya from CBER
    • You'll have the opportunity to ask your burning regulatory questions directly to the regulators in an engaging town hall format! More regulators to be announced soon!

  • FDA Keynotes Presentations
    • Lokesh Bhattacharyya -CBER
    • Alfred Del Grosso - CBER
    • Arulvathani Arudchandran - CDER
    • Wojciech Jankowski - CBER
Networking events to round out the learning experience
  • Luncheon roundtables: No PowerPoint slides here! Join interactive discussions around your challenges, roadblocks, ideas, and solutions to the biggest issues in characterization and bioassay development.
  • Poster and Exhibit Hall: Drive your development and manufacturing efforts forward by meeting the experts behind today's leading technologies and products in the poster and exhibit hall!
  • Multiple networking breaks and seated luncheons, an evening reception in the exhibit hall, and an event app!
3 Pre-Conference Workshops
  • Technology for Analytical Characterization: Formulation and Common Challenges
    • HDX-MS
    • Advancing CE-SDS Technology
    • IM-MS for Characterization of Charge Variants and more!

  • Statistical Analysis, Views and Practical Concepts to Build Understanding and Improve Biological Assay Development - A Modular Approach

  • Taking it to Another Level: Phase Appropriate Validation of Bioassays

海报发表


会期中将在展示会大厅内设置发表海报的空间,可在此展示最新的研究成果。请于2018年10月5日 (五)之前提交海报摘要。

推荐参加的对象


请勿错过这个能够与监管机关主管直接会面谈话的宝贵机会。会期中将分享富含未公开信息的研究发表,将能够带回需多成果。此外,实用建议和产业案例,对于以下部门的研究及技术人员、经理、研究单位负责人、总监等专业人士亦相当有助益。

  • 分析法研究开发
  • CMC
  • 蛋白质分析化学
  • 生物试验开发与技术革新
  • 药物法规的问题及品质保证/管理
  • 制程开发
  • 产品开发
  • 技术部门业务/制造科学
  • 制剂制造
  • 临床供应链采购
  • 生物分析
  • 生物制剂的开发与技术
  • 统计
  • 特性评估

地点

Hilton Washington DC/Rockville Hotel & Executive Meeting Center

Venue Address:

1750 Rockville Pike

Rockville, MD 20852 

Phone: (301) 468-1100

Visit the Hotel Website