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Well Characterized Biologicals


Ensure CMC Success through Novel Characterization Strategies and Regulatory Guidance

November 03-04, 2016 · The Westin Arlington Gateway · Arlington, VA

Event Overview

Event Overview

The leading case study-driven conference for understanding today's characterization strategies and regulatory guidelines to accelerate biologic and biosimilar approval

Well Characterized Biologicals is the industry's most trusted and longest running event to gain the regulatory guidance and analytical characterization strategies you need to ensure accurate CMC submissions.

Mark your calendar to join us at this year's 20th Annual meeting, held November 3-4, 2016 at the The Westin Arlington Gateway in Arlington, VA.

Call for Speakers
Submit Your Proposal by May 27

We are looking for presentations in the following topic areas:

  • Testing Impacts of Protein Variants on Immunogenicity
  • Assay Development Strategies for Vaccines and Other Therapeutics
  • Analytical Methods for Protein Therapeutics
  • Analytical Methods and Characterization Strategies
  • Analytical Strategies for Diverse Products
  • Identifying and Controlling Variants and Impurities
  • Demonstrating Comparability for Biosimilars and Biobetters
  • Extrapolation of Indications with Biosimilar Approvals
  • Interchangeability and Labeling Concerns

Submit Proposal