Remicade (infliximab) is a chimeric monoclonal antibody and has been approved for the treatment of severe rheumatoid arthritis, ankylosing spondylitis and moderate to severe Crohn’s disease, amongst others. The antibody constitutes approximately 75% human and 25% murine protein, consisting of murine variable regions with a human Fc-Gamma-1 isotype.
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, following cleavage of this membrane bound form by the TNF-Alpha converting enzyme (TACE), as free molecules in solution (sTNF-Alpha). 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 Infliximab Innovator and Biosimilar Products
The Fab-related binding function of Remicade (Infliximab) allows the antibody to bind to both soluble and membrane TNF-Alpha with high affinity preventing activation of the TNF receptors on TNF-Alpha sensitive cells. Following binding to mTNF-Alpha, Remicade mediates a range of additional biological responses including reverse signaling which results in apoptosis and cytokine suppression, Complement Dependent Cytotoxicity (CDC) and Antibody Dependent Cellular Cytoxicity (ADCC).
BioOutsource offers a comprehensive range of integrated services to support the biological, physicochemical and structural evaluation of Remicade 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 Remicade Complement Dependent Cytotoxicity assay (CDC assay) and Remicade Antibody Dependent Cellular Cytotoxicity assay (ADCC assay). A number of different potency assays are also available reflecting the diverse mechanisms of action of Remicade. In addition, BioOutsource offer a range of platform methods to assess the physicochemical properties and structural attributes of Remicade innovator and biosimilar products.
We have extensive experience, working with approximately 25 different anti-TNF-alpha therapeutic biosimilar products across the clinical phases. In addition, BioOutsource offer a range of testing and development services to support monoclonal antibody manufacture:
- Remicade Binding Assays
- Remicade Bioassays
- Remicade Physicochemical and Structural Analyses
- Cell Bank Manufacturing
- Biosafety Testing for monoclonal antibodies
Contact our experts to discuss your Remicade biosimilar testing needs.