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W103 - Development and Optimization of a Bioassay to Replace a Phase I Method for Commercialization

‐ Apr 29, 2020 11:00am

Reporter gene assays that measure T-cell activation are generally faster, more consistent, and more robust than traditional cell killing assays while also reflecting a molecule’s mechanism of action. However, despite their advantages, procedures for reporter gene assays can be labor-intensive, resistant to automation, and challenging to fit neatly into an 8-hour workday. This talk describes the development and optimization of a more efficient cell-based reporter-gene potency assay to replace an analogous method used throughout Phase I clinical development of a T-cell recruiting bispecific antibody. Efficiency gains were made by evaluating alternative reporter gene cell lines, strategically optimizing individual procedure steps, and adding options for automation where possible. The new assay was shown to be comparable to the Phase I method and will be validated as the molecule’s commercial potency assay.


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