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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
FDA/CBER

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

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Well Characterized Biologicals

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Ensure CMC Success through Novel Characterization Strategies and Regulatory Guidance

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

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Alternative Language Options:

  • Japanese
  • Korean
  • Taiwanese
  • Chinese
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Sponsors

Sponsors

Confirmed Sponsors

Updated: June 3, 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.

fortebio

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.

Bronze Sponsor
SCIEX

SCIEX helps to improve the world we live in by enabling scientists and laboratory analysts to find answers to the complex analytical challenges they face. The company's global leadership and world-class service and support in the capillary electrophoresis and liquid chromatography-mass spectrometry industry have made it a trusted partner to thousands of the scientists and lab analysts worldwide who are focused on basic research, drug discovery and development, food and environmental testing, forensics and clinical research.

Technology Workshop Sponsors
Bruker Daltonics Caprion Pharmaceuticals, Inc. Unchained Labs
Supporting Sponsor
Antitope
Charles River