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.
Paula Urquhart, PhD
Paula Urquhart is a Bioassay Method Development Scientist at Covance Laboratories, Harrogate UK. Paula joined Covance 3.5 years ago, transferring from an academic research background. She has been focused on the optimization, qualification, and
validation of bioassays for several bioassay markers including interleukin receptors, anti-VEGF, and checkpoint modulators.
Jane Lamerdin, PhD
Eurofins Pharma Discovery Services
Dr. Jane Lamerdin oversees the development of novel cell-based assays for discovery, bioassays for lot release, and neutralizing antibody applications at Eurofins Pharma Discovery Services. Jane has over 18 years of experience in developing cell-based
assays to support drug discovery, particularly in the oncology and inflammation therapeutic areas, as well as high-throughput systems biology research.