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64153 - Workshop Session I: Nuts and Bolts of Bioassays

‐ Apr 18, 2023 11:45am

Bioassays are one of the more complex assays used to support therapeutic product development.  As such, the practical elements of bioassays (the “nuts and bolts”) can also be complex.   These elements can range from the critical reagents selected for use in the bioassay (e.g.-cell line(s), recombinant proteins, serum) to assay formats (e.g.-dual cell-based cytotoxicity assays, single cell-based reporter gene assays, non cell-based binding assays), to the data analysis model selected (e.g.-4 -parameter logistic curve fit, 5-parameter curve fit).  The sustainability of these “nuts and bolts” is vital to establishing and maintaining bioassays over the lifecycle of a therapeutic product. This session will focus on different practical elements of bioassays and their impact on establishing desired method performance.


Alexandre Briguet, F. Hoffmann-La Roche AG

From Research to Market: The Evolving Assay Strategy of a Bi-Specific Antibody

Nancy Sajjadi, Sajjadi Consulting

A Tale of Two Readouts

Paul Faya and Wendy Walton, Eli Lilly and Company

Calculating Non-constant Relative Potency

Kevin Whang, Genentech, a Member of the Roche Group

Surface Plasmon Resonance: Reagent Screening for Product Quality Assessments and Assay Development