Abstract 831: Reproducible, mechanism of action-reflecting reporter based bioassays to enable drug development of biosimilars and biobetters

Abstract

Abstract The demand for biosimilars and bioassays for biosimilars are increasing as the patent cliff approaches for many blockbuster biologics. Recently, the expanded approval of Actemra (Tocilizumab) to treat CAR T-cell-induced cytokine release syndrome (CRS) demonstrated the role of anti-IL-6 blocking drugs as critical for the treatment of serious diseases such as cancer and autoimmune diseases. Here we describe a portfolio of luciferase reporter-based bioassays to support the development and potency determination of biosimilar drugs targeting cytokines such as IL-2, IL-6, IL-12, IL-15, IL-12/23, IL-17, VEGF, RANK, Epo, IFNs, etc. The availability of quantitative, functional bioassays in Thaw-and-Use format provides the benefit of convenience, reproducibility, and transferability. We demonstrate these assays are able to measure relative potency for antibody biologics and detect potency changes for stressed antibody samples. In summary, the reporter-based bioassay portfolio for biosimilars provides a valuable tool for the development, stability testing, and potency determination in manufacture of biosimilars and biobetters. Citation Format: Richard L. Somberg, Rich Moravec, Dun Li, Aileen Paguio, Mei Cong. Reproducible, mechanism of action-reflecting reporter based bioassays to enable drug development of biosimilars and biobetters [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2018; 2018 Apr 14-18; Chicago, IL. Philadelphia (PA): AACR; Cancer Res 2018;78(13 Suppl):Abstract nr 831.