Enbrel (etanercept)

Enbrel (Etanercept) is a fusion protein consisting of human IgG1 Fc Region, genetically fused to a soluble portion of the Tumour Necrosis Factor Receptor p75 and is used for the treatment of severe rheumatoid arthritis, ankylosing spondylitis and Crohn’s disease amongst others.

Target Antigen: TNF-Alpha

TNF-Alpha is a potent pro-inflammatory cytokine involved in a number of different diseases playing an integral role in autoimmune diseases. TNF-Alpha is first generated as a 26 kDa membrane bound protein on activated macrophages and lymphocytes, before undergoing enzymatic cleavage to yield a soluble form. Two different classes of biological drug products that target TNF-Alpha have been approved; TNF-Alpha monoclonal antibodies (Infiximab and Adalimumab) and a soluble TNF-Alpha receptor (Etanercept). Each product class can bind to both the soluble and membrane-bound forms of TNF-Alpha.

Characterization of Etanercept Innovator and Biosimilar Products

Enbrel (etanercept) exerts it’s biological function in a number of different manners. The soluble receptor component of Enbrel allows the fusion protein to neutralize TNF-Alpha by binding with high affinity to the soluble form of TNF-Alpha preventing it’s binding to TNF-Alpha receptors. A range of binding and cell based potency methods can be employed to characterize Enbrels TNF-Alpha receptor-related functions. Enbrel can also bind to membrane bound TNF-Alpha (mTNF) and the Enbrel Fc region is capable of mediating both Complement Dependent Cytotoxicity (CDC) and Antibody Dependent Cellular Cytoxicity (ADCC) in vitro using cell lines constructed to express membrane bound TNF-Alpha as the target cell.

BioOutsource offers a comprehensive range of integrated services to support the biological evaluation of Enbrel including characterization and comparability. Our off-the-shelf binding assays and bioassays include binding measurements for TNF-Alpha and the Fc-Receptors, C1q binding as well as the Enbrel Complement Dependent Cytotoxicity assay (CDC assay) and Enbrel Antibody Dependent Cellular Cytotoxicity assay (ADCC assay). A number of different potency assays are also available.

BioOutsource provides end to end support for Enbrel biosimilar manufacture and has extensive experience in the performance of binding and bioassays to support both the characterization of Enbrel drug substance and drug product as well as performing extensive comparability studies to support clinical applications. In addition, we provide generic testing and development services for all monoclonal antibodies and fusion proteins:

Contact our experts to discuss your Enbrel biosimilar testing needs.

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