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:
- Simponi Binding Assays
- Simponi Bioassays
- Simponi Physicochemical and Structural Analyses
- Biosafety Testing for 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.