Prolytix

Learn how a custom ADA assay was designed, incorporating acid dissociation with the ACE method to overcome drug interference using other standardized formats.

Having a robust immunogenicity assay for accurate evaluation of ADA in animal models is important for enabling effective decision-making during development. Learn how a robust anti-drug antibody assay was developed and was capable of detection at the requisite sensitivity and enabled meaningful interpretation of PK data obtained from the preclinical animal model.

Learn the unique considerations for use of ADA assays in early development, pre-clinical and clinical settings, as well as how to generate high-quality methods at each stage to support successful development and regulatory approval of safe and effective biotherapeutic drugs.