Development and Qualification of a Characterisation Panel to Assess the Biological Activity of Golimumab (Simponi®)

Alexander Knorre, PhD, Head of Bioassay Department, Eurofins BioPharma Product Testing Munich GmbH, AlexanderKnorre@eurofins.com

WHO, US FDA, and EU guidelines request the use of a variety of analytical methods for therapeutic monoclonal antibody biosimilar characterisation and comparison with reference products. In order to support clients with accelerating their biosimilar development programmes, Eurofins BioPharma Product Testing Munich has set up and qualified a characterisation panel for the biological activity of Golimumab (Simponi®) using the bioassay experience and expertise of its Potency Bioassay Team, which has provided cGMP bioassay testing and bioassay development services for more than 30 years.

Golimumab (Simponi®) is a fully human monoclonal IgG1 antibody that inhibits binding of TNFα to its receptor TNFR. The characterisation panel addresses Fab functional activity using a cell based potency assay and Fab binding by a SPR binding assay to soluble TNFα as well as by a FACS binding assay to membranous TNFα. An ADCC and a CDC assay are available for characterisation of the Fc function of this therapeutic antibody. These cell based assays are supplemented by a panel of Biacore SPR binding kinetic assays for binding to FcγRI/CD64, FcγRIIA131R/CD32A, FcγRIIIA158V/CD16A, FcRn and binding to complement C1q ELISA/C1q SPR assay. The Biacore SPR assays are qualified as kinetic assays, and the cell-based assays are set up as potency assays. As these methods are used both for data generation for Quality Target Product Profile (QTPP) and for clone selection, the assays can be ordered in any combination as either GMP or non-GxP service.

This assay panel can serve as a platform for other anti TNFα therapeutic monoclonal antibodies. Furthermore, the Characterisation Team has experience with the following Biacore SPR Fcγ receptor characterisation assays, which are established for therapeutic antibody innovator molecules and can be also set up for biosimilars: Binding to FcγRIIIA158F (CD16A), FcγRIIIB (CD16B), FcγRIIA131H (CD32A) and FcγRIIB/C (CD32B/C).

In addition, the Bioassay and Characterisation Assay teams of Eurofins Munich work on a variety of client specific innovator molecule bioassays using a diverse range of bioassay types (cell-based, ELISA, SPR, in vivo) and have experience with biosimilar molecules like Enbrel (Etanercept), Remicade (Infliximab), Humira (Adalimumab), Avastin (Bevacizumab), and Rituxan (Rituximab).

For more information,visit www.eurofins.com/biosimilars