Implementing Novel Methods & Strategies for Characterizing Fc Effector Functions of Antibody Drug Conjugates

Time: 10:00 am
day: Day Two

Details:

  • ADCs with Fc effector functions pose challenges to CMC, including requirements for in-depth characterization and control which can be difficult to navigate in early development phases due to lack of in vivo and/or clinical data
  • Traditional methods of assessing Fc effector functions, such as reporter gene bioassays, can be over-sensitive to small changes in early process development due to Fcy receptor over overexpression in the model
  • Explore how more functionally-relevant assays using PBMCs and live cell imaging of target cells can help determine perceived level of contribution of Fc effector function towards MoA, and can lessen perceived safety risks over concerns with data generated with traditional assays

Speakers: