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October 25-27, 2017
Hilton Washington DC/Rockville Hotel & Executive Meeting Center,
Rockville, MD

Ensure CMC Success and Expedite Your Product’s Path to Market by Optimizing Protein Characterization Strategies and CMC Bioassay Development

Gain Practical Advice from Numerous Case Studies, Regulatory Perspectives, and Technology Applications to Accelerate Your Own Biologics Programs

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
  • Analytical Characterization Strategies for ADCs, Bispecifics, and Fusion Proteins
  • Case Studies of Protein Characterization and Product Comparability
  • Biosimilar Characterization and Comparability
  • Analytical Methods for Identification and Quantification of Host Cell Proteins
  • Strategies for Higher Order Structure
  • Methods for Identifying, Monitoring and Controlling Product and Process Variants and Impurities
  • Strategies for Stability Studies for Diverse Products
Biological Assays Track
  • QbD and DoE Approaches to Bioassay Development
  • Lifecycle Management of Bioassays and Assay Changes to Commercial Products
  • CMC Biological Assay Case Studies
  • Bioassay Development for Biosimilars and Complex Molecules
  • Method Bridging and Method Tech Transfer for Bioassays
  • Potency Assays: Automation, Statistics & Critical Reagents
  • Regulatory Perspectives on Method Lifecycle Development for Bioassays
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

Unsurpassed Networking Opportunities

Luncheon Roundtable Discussions

Taking place during the networking luncheon each day, our roundtable discussions are your chance to take a break from PowerPoint slides to discuss challenges, roadblocks, and solutions to the biggest issues in characterization, immunogenicity, and biosimilars in an interactive setting.

Poster and Exhibit Hall

Drive your development and manufacturing efforts forward by meeting the experts behind today’s leading technologies and products at the most comprehensive and relevant exhibit hall.

Networking Reception

Taking place in the exhibit hall, the Networking Reception is the place to meet, connect, and establish new relationships with the 200+ scientists and executives that attend year after year. 

Present a Scientific Poster

Highlight your company's latest research findings by presenting a scientific poster, which will be displayed in the Exhibit & Poster Hall during the event. The deadline to submit your poster is Wednesday, September 27, 2017.

Who Should Attend?

Send a team to capitalize on this unique opportunity to meet face-to-face with multiple regulators. Benefit from hearing unpublished data that will only be shared in person at this meeting. The practical advice and industry case studies at this event will benefit Scientists, Technicians, Managers, Lab Heads, Directors and other specialists in the following departments:

  • Analytical R&D     
  • CMC     
  • Protein Analytical Chemistry     
  • Biological Assays      
  • Bioassay Development and Innovation     
  • Regulatory Affairs and QA/QC     
  • Process Development     
  • Product Development     
  • Technical Operations/Manufacturing Sciences     
  • Drug Product Manufacturing     
  • Clinical Supply Chain Procurement     
  • Bioanalytics     
  • Biological Development and Technologies     
  • Statistics     
  • Characterization

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