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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


Ensure CMC Success through Novel Characterization Strategies and Regulatory Guidance

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



Confirmed Exhibitors

Updated: July 15, 2015

AbD Serotec, a Bio-Rad Company

Bruker Corporation

Charles River

EMD Millipore

Eurofins Lancaster Laboratories, Inc.

KBI Biopharma, Inc.

KCAS Bioanalytical & Biomarker Services

Pall ForteBio LLC



SQI Diagnostics, Inc.

Thermo Fisher Scientific

Unchained Labs

Charles River