Bioanalysis Zone

Development and Validation of Cell-based Assays for the Detection of Neutralizing Antibodies Against Therapeutic Proteins

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In association with PPD, Bioanalysis Zone is pleased to present a webinar on ‘Development and Validation of Cell-based Assays for the Detection of Neutralizing Antibodies Against Therapeutic Proteins’. One major challenge in bioanalysis of large molecules is the potential for provoking an unwanted immune response. Neutralizing antibodies (NAbs), which bind to drug products and can potentially diminish or eliminate the associated biological activity, are an unintended and undesirable outcome of some drug products. The purpose of this webinar is to outline the basic steps involved in the development and validation of cell-based assays for the detection of NAbs to therapeutic proteins.

Topics covered:

This webinar covers the key steps in designing and testing a cell-based NAb assay:

  • Selecting a suitable cell line
  • Choosing the proper cellular response (endpoint method)
  • Selection of proper controls
  • Optimization of assay parameters
  • Validation
  • Transfer of assays to a contract research lab.

Who should watch?

Senior directors, directors, clinicians, principal scientists, principal investigators, managers, project/team leaders in:

  • Bioanalytical development
  • High-throughput/high-content screening operations
  • Drug discovery/validation
  • In vitro sciences
  • Pre-clinical development
  • Medicinal chemistry
  • Pharmacovigilance and safety testing
  • Global research and development
  • Business development.

Panelist’s biography

Pierre Jolicoeur, Ph.D.

Before joining PPD, Dr. Jolicoeur was associate director for ligand binding and cell-based assay services for another competitor CRO. He was responsible for coordinating all contracted work and managing the bioanalytical section. He also reviewed and approved all scientific, regulatory and operational aspects of cell-based assays for clinical and nonclinical studies. Dr. Jolicoeur’s experience also has included positions as manager for research and development and viral custom services as well as study director for preclinical services at Qbiogene, Inc.

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