Simponi (golimumab)

Simponi (golimumab) is a fully human sequence derived IgG1 monoclonal antibody and is approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.

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 molecules are homotrimers and exist either as membrane-bound TNF-alpha on the cell surface (mTNF-Alpha) or, as free molecules in solution (sTNF-Alpha), following cleavage from the membrane by the TNF-Alpha converting enzyme (TACE).

Characterization of Golimumab Innovator and Biosimilar Products

Simponi (golimumab) is a fully human sequence derived IgG1 monoclonal antibody and is approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and ulcerative colitis.  The Fab-region of Simponi allows the antibody to form stable complexes with both soluble and transmembrane TNF-alpha.  As a result, several mechanisms of action are proposed including the prevention of activation of TNF receptors on TNF-alpha sensitive cells, direct action as a result of mAb binding and effector function by binding cell-associated TNF-alpha and recruitment of effector molecules.

BioOutsource has extensive experience in the development, optimization, and validation of a wide range of different types of binding assays and immunoassays for Simponi to support the biopharmaceutical industry.  Our off-the-shelf methodologies include assays to evaluate the interaction between the mAb and TNF-alpha, as well as functional activities associated with the primary mechanism of action of Simponi for a range of therapeutic uses. In addition, we also offer a range of platform methods to assess the physicochemical properties and structural attributes of Golimumab innovator and biosimilar products.

BioOutsource also offer a range of testing and development services to support the manufacture of NBE monoclonal antibodies:

Our research and development scientists continue to develop new assays for Simponi (golimumab) biosimilars. If you require a method that is not listed then please contact our scientist to discuss your requirements.

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