Defining PQAs Linked to Color Change in Biotherapeutics During Process Development

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Webinar Date/Time: Tue, Aug 15, 2023 11:00 AM EDT

Tackle complex characterization challenges for protein therapeutics with novel workflows. Learn about the link between AGE formation and color change in final drug products and how to develop assays for rapid monitoring and tracking of these PTMs.

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Event Overview:

Because a product quality attribute (PQA) may impact efficacy and safety, the color of a protein therapeutic under process development, and any changes to that color require close monitoring. Establishing multi-attribute methodology (MAM) to track the cause of color change facilitates efficiency in this monitoring by enabling rapid hot spot analysis for the continued development of the drug. This webinar discusses the use of a LC-MS workflow for detailed peptide mapping of PTMs to:

  • Define potential PQAs associated with color change
  • Investigate the link between color change and advanced glycan end products (AGEs)
  • Characterize and localize AGEs linked to color change
  • Establish a MAM to quantitatively track AGEs

Key Learning Objectives:

  • Learn how to establish potential CQAs through in-depth characterization.
  • Discover the benefits of electron activated dissociation mass spectrometry for characterizing labile PTMs.
  • Develop and implement novel workflows to respond to new challenges.

Who Should Attend:

  • Biopharma Scientists, QC scientists, Process Control scientist, Analytical development labs, Cell Line development scientists, Early development


Andrew D. Mahan, PhD
Associate Director
Mass Spec Group Leader
Cell Engineering and Analytical Sciences
Janssen Research

Dr Andrew D. Mahan is enthusiastic and passionate about mass spectrometry and its role in bringing new medicines to patients. His mission focuses on the continuous improvement of mass spectrometry and in the flawless execution of analytical methods to support the organizations and teams he is a part of. Dr Andrew D. Mahan received his PhD in analytical chemistry from Drexel University and is currently the Associate Director and Mass Spec Group Leader of Cell Engineering and Analytical Sciences at Janssen Research in Spring House, PA, USA. There, he is focused on the analytical support of the cell line development group, applying mass spectrometry to solve problems and understand protein

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