Well Characterized Biologics & Biological Assays
地点:美国马里兰州,Rockville,Hilton Washington DC/Rockville Hotel & Executive Meeting Center


Well Characterized Biologics & Biological Assays中,可学习制作CMC核准申请文件所需的规范遵守指南及分析性表徵分析策略,本学会拥有优异成绩并获得众多业界人士信赖。

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

Well Characterized Biologicals Track
  • Regulatory Perspectives on Common Pitfalls in Your Analytical and CMC Studies
  • Product Characterization Case Studies on ADCs, Bispecifics, Fusion Proteins
  • Characterization of Vaccines, Combination Products, Complex Molecules
  • Biosimilar Characterization and Comparability
  • Analytical Strategies for Host Cell Proteins and Particulates
  • Higher Order Structure
  • Control of Product and Process Variants and Impurities
  • Emerging Analytical Technologies and Applications
Biological Assays Track
  • Automation of Bioassays and Other Emerging Technologies
  • Use of DoE Approaches in Bioassay Development
  • Regulatory Perspectives on Method Lifecycle Development for Bioassays
  • Method Bridging and Method Tech Transfer for Bioassays
  • QbD and Continuous Method Verification for Bioassays
  • How to Maintain a State of Method Control for Legacy Bioassays
  • Monitoring Stability of Reference Standards for Potency Assays
  • Bioassay Development for Biosimilars
  • Bioassay Case Studies for ADCs, Bispecifics, Cell therapies, and DNA/RNA Therapeutics
Event Highlights
  • Multiple FDA and Regulatory Speakers and Perspectives
  • Case Studies with Practical Advice You Can Apply in Your CMC Programs
  • Hear New Data and Lessons Learned in a Vibrant, Information-Sharing Environment
  • Shared Poster Sessions and Networking Breaks for Both Tracks
  • Exhibit Hall Showcasing the Latest Analytical and Bioassay Technologies and Services
  • Evening Cocktail Reception for Meeting New Colleagues and Potential Collaborators
  • Two In-depth Pre-Conference Workshops for More Personalized Learning

New for 2017! Two In-Depth Pre-Conference Workshops

An Introduction to Bioassay Development

This workshops focuses on the role of Bioassays in the CMC process and product characterization lifecycle and covers topics including:

  • Strategies for the design, development, and validation of biological assays for a variety of different molecules, including complex, non-platform modalities.
  • The role of automation, new technologies, and statistics in the bioassay development and validation process.
  • Latest regulatory expectations and steps you can take to ensure your biological assay will meet the ever-higher industry standards.
Mass Spectrometry and Other Analytical Technology to Enable Protein and Molecule Characterization

This multi-speaker workshop will begin with an introduction to an array of analytical technologies currently used. Attendees will then hear a diverse range of case studies and unpublished data discussing these relevant and useful analytical technologies for characterization.

Topics covered include:

  • Using QC Friendly Mass Spectrometry to Quantitate the Critical Charge Variant from a Minor Component in Combination
  • Applications of 2D NMR for Characterization of Monoclonal Anitbody Therapeutics
  • Mass Spec for Potency Testing of Adenovirus Vectors
  • Analytical Technologies for Formulation Development and Characterization of Proteins and Molecules










  •   分析法研究开发
  •   CMC
  •   蛋白质分析化学
  •   生物化验开发
  •   监管问题及品质保证/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



请于2017年9月27日(三)之前缴交海报发表摘要 (请于该期限之前缴交全额学会报名费及海报发表费用) 。摘要将刊载于学会数据上。截止日期过后仅于尚有空位时接受申请。

Hilton Washington DC/Rockville Hotel & Executive Meeting Center

Venue Address:

1750 Rockville Pike,
Rockville, MD 20852

Book Your Hotel Room Here

Phone: (301) 468-1100