Conversion of a Potency Assay from Cell-Based Binding to AlphaLISA
Summary: A relative potency assay was based upon inhibition of a mAb binding to a cell-surface expressed antigen on viable cells and assessed via flow cytometry. The assay produced data that were variable and insufficiently accurate. To address the assay’s shortcomings, a new relative potency assay with similar molecular underpinnings was developed, based upon an AlphaLISA platform. The resulting assay was not only significantly more accurate and less variable than the original FACS assay, it was also overwhelmingly easier and faster to execute.