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October 9, 2019
11 am to 12 pm EDT
Establishing Qualified Bioassays for Checkpoint Receptors to Implement in QC Lot Release: Case Studies on PD-1 and SIRPα  



Webinar Description:

Regulation of immune responses is tightly controlled through a balance of co-stimulatory and inhibitory checkpoint receptors, which is often exploited by many cancer cell types. Therapeutics that block inhibitory receptors or activate immuno-stimulatory checkpoint receptors have proved to be powerful agents to restore anti-tumor immune responses. However, developing drugs targeting these checkpoint proteins has proved to be quite challenging, as cell-based assays that are used to screen for functional drugs often involve the use of human primary cells, and have long, complicated protocols. These assays frequently require use of multiple types of cells in the assay and the variability of primary cells make them difficult for implementation in routine testing for lot release.

Eurofins DiscoverX’s PathHunter cell-based assays measure receptor activation and signaling for co-stimulatory receptors and inhibitory checkpoint receptors. These homogeneous bioassays are based on the native biology of the relevant receptors, and use convenient thaw-and-use cryopreserved cells to deliver excellent accuracy, precision, and reproducibility. Furthermore, these robust assays lend themselves well to use in lead optimization, potency determination & stability testing of the drugs. These assays are also highly scalable and suitable for automation.

In this webinar, we will present qualification studies of bioassays developed for drugs targeting 2 clinically important immunotherapy targets: the PD-1/PD-L1 and SIRPa/CD47 signaling axes. Case study on PathHunter PD-1 Signaling Bioassay will include data from a recent independent qualification study completed by BioOutsource (part of Sartorius Stedim). The second case study will describe the qualification of the PathHunter SIRPα Signaling Bioassay, which is the first and only commercially-available bioassay for potency and stability testing of biologics targeting the SIRPa-CD47 signaling axis.

Learning Objectives

  • Establishing parameters to qualify and validate bioassay for potency testing
  • Case study on qualification/validation of PathHunter PD-1 Signaling Bioassay for implementation in QC lot release
  • Case study on development and qualification of PathHunter SIRPα Signaling Bioassay that quantifies an early step in the activation cascade of SIRPα signaling.


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Laura McAleer, PhD, Senior Scientist
R&D and BioAnalytical Technical Development
Sartorius Stedim BioOutsource Limited

Laura McAleer joined Sartorius Stedim Biooutsource in 2014 as a Technical Development Scientist. She holds a joint honours degree in Immunology and Microbiology, and a PhD in Molecular Parasitology at the Strathclyde Institute of Pharmacy and Biomedical Sciences. Laura’s background in immunology has provided extensive experience for her current role in developing and qualifying Bioassays and ELISAs for use in the characterisation of monoclonal antibodies.

Laura McAleer image

Jane Lamerdin, PhD
Director R&D
Eurofins DiscoverX

Dr. Jane Lamerdin oversees the development of novel cell-based assays for discovery, bioassays for lot release, and neutralizing antibody applications at Eurofins DiscoverX. 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.


Cost: No Cost!