Bioanalysis Zone

Development of neutralizing antibody assays to support clinical safety assessment: when is a cell-based assay required and what challenges can you expect?

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It is important to detect anti-drug neutralizing antibodies (NAbs) generated against a therapeutic protein in order to have a complete efficacy and safety profile for the therapeutic drug in vivo. In vitro cell-based assays provide a physiological system for NAb detection, however, they are complex to develop and use in a regulatory setting. As neutralization assays should reflect the mechanism of action (MoA) of the therapeutic drug products, the MoA, for some, is reflected by a series of events that are interdependent, while for others the MoA relies on the displacement of the receptor–ligand interaction primarily. In such cases, non-cell-based competitive ligand binding assays can be proposed as alternative approaches for NAb detection.
This webinar will discuss the key parameters and readouts to consider for the development of cell-based neutralizing assays.

What will you learn?

  • When to use a binding assay to evaluate whether the ADAs detected are neutralizing.
  • When a cell-based approach is required to demonstrate neutralization.
  • Important parameters to consider when developing a cell-based assay.
  • Similarities and differences when comparing to potency neutralizing assays, which could reduce the assay development timeline.
  • Available readouts for cell-based assays and how to select the right one.

Who may this interest?

  • Bioanalytical scientists
  • Managers considering whether a cell-based assay should be included in their program
  • Key decision makers for clinical outsourcing of bioanalytical programs
  • R&D scientists working on cell-based and ligand binding assays
  • Bioanalytical scientists working on immunogenicity assays

Speaker


Danielle Salha

Danielle Salha, PhD
Director, Ligand Binding Assays
Altasciences

 

 

Dr Salha joined Altasciences (QC, Canada) in September 2017 as Director, Ligand Binding Assays. Dr Salha leads a team of 30 scientists, Quality Control Auditors and analysts dedicated to method development, assay validation and sample analysis to support clinical and preclinical PK, PD and immunogenicity studies.

Prior to joining Altasciences, Dr Salha was a Study Director at Charles River Laboratories (QC, Canada), where she supported preclinical and clinical immunogenicity studies. Prior to that, she worked at Sanofi Pasteur (PA, USA) for over 14 years, supporting different functions and departments across the spectrum of product development, from discovery to Phase II clinical development, holding positions of increasing responsibility. In her last position at Sanofi Pasteur, Dr Salha led the Bioanalytical Department to develop and validate in vitro potency assays to support clinical Phase I and II product release, including vaccines and monoclonal antibodies.

Dr Salha has authored or co-authored over 10 peer-reviewed publications and has four patent applications. She has presented numerous posters and presentations in the bioanalytical and R&D domain at several international conferences.

Dr Salha received her Bachelor of Science at the Université de Montréal (QC, Canada) and her PhD from the Department of Immunology and Microbiology at McGill University (QC, Canada). Her thesis focused on the characterization of T-cell immune responses to SIV vaccine candidates in cynomolgus macaques, comparing fast progressors and long-term-survivors.

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