Immunogenicity Uses Affibody® Ligand
A Novel Immunogenicity Assay Using the Affibody® Ligand Can Overcome Inherent Control Challenges
Authors: Jayne A. Keifer, Kristen M. Mark, Gwendolyn M. Wise-Blackman, and Ana T. Menendez
Biopharmaceutical therapies have the potential to induce immune responses that can cause serious side effects or lead to a loss of therapeutic efficacy. At present, regulatory agencies place the burden of essential immune status monitoring on drug manufacturers. To offset the fact that these methods often lack positive human controls, this study investigated a method design using a synthetic molecule - the Affibody® technology - which functions by recognizing immunoglobulin presentation in serums and is capable of identification of immune status in a multitude of species. This technology has been validated in GMP conditions.