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Reproducible, MoA-Reflecting Reporter-Based Bioassays to Enable Drug Development of Biosimilars and Biobetters

Part # PS350

Abstract

Richard Moravec, Dun Li, Jennifer Wilkinson, Frank Fan and Mei Cong
Promega Corporation, 2800 Woods Hollow Rd, Madison, WI 53711

IL-2 and IL-15 are still clinically important cytokines as researchers look to improve potency, patient tolerance, and response by developing new molecules with sustained and targeted activities. We have developed luciferase reporter bioassays which individually can be used for the quantitation of a variety of cytokines and growth factors including IL-2, IL-6, IL-12, IL-15, IL-17, IL-23, TNFα, TGFβ, VEGF, and RANKL using respective mechanism of action pathways. The bioassay format is based on thaw-and-use cells, eliminating the need to establish and pre-culture cytokine responsive cell lines which provides the benefits of convenience, reproducibility, and transferability. We demonstrate these assays measure cytokine response and inhibition with blocking drugs or potency changes from stressed samples. In summary, these reporter-based bioassays provide valuable tools for the development, stability testing, and potency determination in the manufacture of cytokine biosimilars and biobetters.

Printed in USA.