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. Register for our webinar to find out more about The New Era of Ani-Drug Antibody assays.
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. REpAp® 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