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Advanced Characterization of Intact Biotherapeutics using CE-MS



  August 28, 2019

  8:00 a.m. PDT, 11:00 a.m. EDT, 16:00 BST, 17:00 CEST




Determining and assessing critical quality attributes (CQAs) during development of biotherapeutics not only aids in the understanding of the biotherapeutic but the process by which it is made. While small molecule CQAs are generally associated with purity, stability etc, biotherapeutics are considerably more complex and often the CQAs largely affect efficacy and safety. One key CQA is the assessment of the glycans associated with a biotherapeutic, whether in the intact form of the biologic or in a released form. ZipChip, a microfluidic CE system, is ideally suited to the breadth of applications for CQA assessment of therapeutics. Whether it is assessment of intact glycoforms of a biotherapeutic (including silyation), as seen in the work at BMS or small molecule pharmacokinetic analysis to determine a metabolic profile (University of Kentucky), ZipChip provides rapid assessment of the quality and fate of the therapeutic being assessed.

In both cases, ZipChip allows for rapid separation of these molecules for the fast determination and assessment of the CQA (or metabolite) of interest, including separation and mass spec determination of molecules not easily seen by other separation techniques.

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Key Learning Objectives

  • How CE-MS was used to advance characterization of biotherapeutics on intact level
  • How to get fast glycoform analysis of fusion proteins
  • About a microfluidic CE-MS system used for pharmacokinetic analysis to determine metabolic profile
  • How ZipChip was used for CQA assessment of therapeutics

Who Should Attend

  • MS practitioners
  • Researchers/ R&D Mangagers
  • Laboratory Managers/ Directors / Supervisors
  • Laboratory Technicians / Operators


Dr. Ekaterina (Kate) Deyanova,
Sr. Research Scientist,
Bristol-Myers Squibb
Zachary Kelley,
Research Assistant,
University of Kentucky


Ann Thayer,
Contributing Editor,
C&EN Media Group