From The Stage

Assay Design for Immunogenicity Testing: Cell-Based or Ligand Binding?

David Rusnak
Posted by David Rusnak / / Cell-Based Assays, Immunogenicity

Unlike small-molecule drugs, large molecule therapeutics face a high chance of detection by the immune system, and are therefore more apt to trigger alarms. The resulting immune responses can range from largely benign to life-threatening, which is why immunogenicity testing has become a critical requirement in the biologics development process. But, the development and implementation of such assays can be technically challenging, and this is causing differing industry opinions around the use of cell-based functional assays vs. non-cell-based competitive ligand binding assays for NAb detection. The Turning Tide Cell-based assays…