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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



Confirmed Sponsors

Updated: May 15, 2015

Silver Sponsors
Charles River

Charles River, a global contract research organization, offers comprehensive biologics testing services including viral clearance studies; biosafety, impurity, and potency testing; cell banking and cell line characterization. Dedicated to reliability, we adhere to your timelines and proactively communicate the status of your testing from receipt to results delivery.


Pall ForteBio LLC is one of the world's leading providers of label-free, high-throughput and micro-volume analysis solutions for life sciences, biopharmaceutical research, development and manufacturing. The product portfolio includes instruments, software and biosensors that enable scientists to measure biomolecular interaction kinetics, affinity, and concentration for their medical and biological research.

Supporting Sponsor
Technology Workshop Sponsors
Bruker Daltonics Unchained Labs
Charles River