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Reston, VA


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FDA Presentations

Preview Past FDA Speaker Presentations

Top Ten List of Analytical Inadequacies in IND and BLA Submissions
Alfred Del Grosso
Team Leader, Analytical Chemistry

Regulatory Perspective on Comparability Assessments of Biotechnology Products
Audrey Jia, M.D., Ph.D.
Division of Monoclonal Antibodies

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Well Characterized Biologicals


Novel Characterization Strategies and Regulatory Guidance to Ensure CMC Success

November 09-10, 2015 · Hyatt Regency Reston · Reston, VA

Event Overview

Event Overview

IBC's 19th Annual Well Characterized Biologicals meeting provides the regulatory guidance and analytical characterization strategies you need to ensure accurate CMC submissions.

For nearly two decades, this case-study driven event has led the industry by consistently providing the latest updates on the most novel bioanalytical methods for sound characterization of biologics.

With over 15 regulatory speakers, key insights on analytical method development and characterization strategies, and critical information on biosimilars, this year's event is a can't-miss.

Start planning your team's trip to this year's meeting and take advantage of this rare opportunity to meet and learn from multiple regulators, industry experts and leading national researchers who provide the guidance and lessons learned you need to improve your protein characterization efforts.

"An Incredible gathering of industry professionals sharing their unique and effective strategies for purification and characterization of Biotherapeutics." - Peter Jordan, Scilucent LLC

Who Should Attend

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
  • Bioassay Development
  • Regulatory Affairs and QA/QC
  • Process Development
  • Product Development
  • Technical Operations/Manufacturing Sciences
  • Drug Product Manufacturing
  • Clinical Supply Chain Procurement

"Well organized conference, wide variety of topics covered by the speakers." - Suranjana Haldar, Dr. Reddy's Lab LTD

Co-Located With: IBC's 16th Annual
Immunogenicity for Biotherapeutics

As the longest and most comprehensive event on predicting and de-risking immune responses from creation to product, this year's event takes a deep-dive into critical issues for understanding and managing immunogenicity from concept to product.

Charles River