New Era in Anti-Drug Antibody Assays

Anti-Drug Antibody (ADA) assays such as ligand-based assays are critical to assess the clinical efficacy and safety of a biological drug. ADA assays rely on control reagents that mimic the ADA response to the biological drug being tested.

These positive controls typically consist of animal-derived (e.g., rabbits) pooled polyclonal antibodies (pAb) or human monoclonal antibody (mAb) reference panels against the target protein drug. For timely approval of a protein therapeutic, ADA assays should be developed and validated within 18 months of filing with the FDA. This can be a significant hurdle for many scientists in the industry. Rapid Novor is able to streamline, optimize the process of antibody discovery and minimize cost for anti-drug antibody development.

Furthermore, due to the finite and variable nature of animal pAb production, new batches still require validation and characterization prior to clinical testing. In contrast, human mAb reference panels can be tedious to generate because they must recapitulate as close as possible the ADA response, which is polyclonal. Solution for the Challenge Recombinant mAbs (rAbs) derived from the anti-drug pAb offer a solution to the aforementioned problems.

Using Rapid Novor’s REpAb® Antibody Discovery Platform, pAb sequences can be mined from the naturally occurring patient polyclonal ADA response. Such rAbs would be strictly defined and bear high fidelity. REpAb® could also be used to generate more precise animal-derived pAb ADA positive controls. With REpAb®’s technology, scientists can confidently rely on new and improved ADA positive controls to ease the characterization of ADA responses. You Will Learn How rAb panels derived with proteomics-informed data from anti-drug pAb preparations address current ADA assay shortcomings Learnings from Factor VII ADA responses as a case study Modeling new panels after 2015’s WHO-developed anti-erythropoietin mAb reference panel with ease Review of the role of rAb controls in biosimilar pre-clinical and clinical testing How Polyclonal Antibody Protein Sequencing breakthrough offers a better method to generate rAbs for ADA reference panels

Overview of how to gain direct access to the ADA response Review of how REpAb® complements your pipeline efforts Discussion of how the antibody-specific insights provided by our platform can strengthen characterization studies. Speaker Anthony Stajduhar Director of International Business Development at Rapid NovorAnthony Stajduhar, B.Eng. Director of International Business Development at Rapid Novor Anthony works with leading researchers in antibody discovery and diagnostic development to understand their needs and ensure that REpAp® polyclonal antibody sequencing technology complements existing approaches and/or provides a complete end-to-end solution. Anthony is dedicated to solving challenging technical problems in the biomedical field, while enriching the lives of humans around the world.