Antibodies To A Derivatized Protein

Overcoming Free Drug and Matrix Effects in Detecting Antibodies to a Derivatized Protein

Authors: Valerie Stratico, MS, Ana T. Menendez, PhD, and Gwendolyn Wise-Blackman, PhD

Summary: Anti-drug antibodies can cause a variety of adverse clinical reactions; therefore, it is critical to develop immunoassays with increased sensitivity designed to detect those antibodies against therapeutic proteins. Many methods to derivatize proteins are being implemented to increase their half-life. However, the presence of the drug itself in the sample can obstruct the signal during immunogenicity testing and lead to dangerous false negatives. Matrix effects can also interfere with immunogenicity analysis. This presentation describes development procedures chosen to reduce this effect on Protein Z and discusses validation results.