About this webinar
In this webinar, participants will learn about current challenges and considerations for bioanalysis for cell and gene therapy (CGT)-based therapeutic products, with a focus on the impact of pre-existing anti-drug antibodies (ADA) on the development and interpretation of ligand-binding (or cell-based) ADA assays. First, the presenter will provide an overview of pre-existing antibodies: why they might be present in patient samples, how they can impact drug safety, how they can impact quantitation of drug in patient samples, and how they can impact the interpretation of standard ADA assay results. Next, the presenter will provide a brief review of the literature on pre-existing antibodies and immunogenicity assessments (with a focus on AAPS white papers), describing three potential approaches for assessing immunogenicity in patient samples when faced with a population with high frequency of pre-existing antibodies. Finally, the majority of the webinar will focus on case examples from the literature highlighting the impact of pre-existing antibodies (PEAs) on ADA assessments for CGT products: (1) PEAs and CRISPR/Cas9 therapeutic components; (2) PEAs and AAVs (adeno-associated viruses); and (3) PEAs and PEG polymer. The webinar will conclude with time for Q & A from participants, and a series of thoughtful questions for participants in terms of how the community might approach the complexities associated with ADA development and implementation for cell and gene therapies currently in development as well as on the horizon.
- Describe how high prevalence of pre-existing antibodies to a therapeutic component can potentially influence both safety and bioanalysis.
- Identify three approaches from the literature to the analysis of immunogenicity data from patients in populations with high levels of pre-existing antibodies.
- Provide at least 2 examples of cell & gene therapy product types that have the potential for high prevalence of pre-existing antibodies against one of the therapeutic components and explain the etiology of these pre-existing antibodies.
- Describe at least 3 examples of assay types that can be used to characterize ADAs against different CGT therapeutic components (such as assays to detect ADAs against PEG, AAVs, and CRISPR system components).