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The Critical Role of Forced Degradation in Method Development, Manufacturability, and CMC Strategy

Summary:​​ Join us to discover the critical role of forced degradation conditions in method development, manufacturability, aggregation, and other essential quality attributes. This session will delve into the analysis of an IgG1 antibody subjected to various forced degradation pathways, utilizing advanced techniques such as SV-AUC, SEC-MALS, and DLS. Gain valuable insights into sedimentation coefficients, molecular weight, polydispersity, and particle size analysis, and understand how these factors help optimize the CMC strategy of your monoclonal antibody therapeutics.

KEY LEARNING OBJECTIVES

  • Understand the importance of forced degradation studies in the development and quality assessment of biotherapeutics.
  • Learn how advanced techniques help to understand and evaluate stability and critical quality attributes.
  • Explore how data from forced degradation studies inform method development and manufacturability decisions.
Click Here To Register for the Webinar

FEATURED SPEAKER

Brent Kennedy headshot

BRENT KENNEDY
Manager
Biologics Analytical Services
Catalent

Brent Kennedy has over 24 years of expertise in biophysical and biochemical analytics. He leads a team of scientists focused on the characterization of monoclonal antibodies (mAbs) and antibody-drug conjugates (ADCs). Brent holds a BA in Cell Biology from the University of Northern Colorado and is highly skilled in advanced characterization techniques such as SEC-MALS and SV-AUC technologies.