Accelerating Biologics & Biosimilars Development: Case Studies for Potency Bioassays

A quantitative and robust bioassay that is reflective of the MOA of the drug is a critical component of any development program. Our cell-based assay platform addresses these requirements and includes simple bioassays based on the native biology of the relevant receptors for potency determination & stability testing of biological drugs. These homogeneous assays employ convenient thaw-and-use cryopreserved cells to provide excellent accuracy, precision, and reproducibility. These assays are also highly scalable and suitable for automation. We will share examples from our PathHunter® cell-based assay platform with bioassay qualification data for representative biosimilar and immune-oncology targets, and a bridging study to replace a traditional bioassay for QC lot release.