Humira (Adalimumab) is a fully humanized monoclonal antibody and has been approved for the treatment of severe rheumatoid arthritis, ankylosing spondylitis and Crohn’s disease, amongst others. Humira possesses a wide range of distinct biological activities, mirroring the biology of TNF-alpha and it’s ability to function as both a ligand and as a receptor.
Target Antigen: TNF-Alpha
TNF-Alpha is a potent pro-inflammatory cytokine that plays an integral role in a number of different autoimmune diseases. TNF-Alpha molecules are homotrimers and exist either as membrane-bound TNF-alpha on cell surfaces (mTNF-alpha) or as free molecules in solution (sTNF-Alpha), following cleavage of the membrane-bound form by the TNF-alpha converting enzyme (TACE). 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 Adalimumab Innovator and Biosimilar Products
The Fab-related binding function of Humira (Adalimumab) 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, Humira mediates a range of additional biological responses including 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 Humira including characterization, 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 Humira Complement Dependent Cytotoxicity assay (CDC assay) and Humira Antibody Dependent Cellular Cytotoxicity assay (ADCC assay). A number of different potency assays are also available reflecting the diverse mechanisms of action of Humira as well as a range of platform methods to assess physicochemical properties and structural attributes.
BioOutsource has extensive experience working with over 15 different Humira biosimilar products across the clinical phases. In Addition, we also provide a range of generic testing and development services for monoclonal antibodies:
- Humira Binding Assays
- Humira Bioassays
- Humira Physicochemical and Structural Analyses
- Cell Bank Manufacturing
- Biosafety Testing for Monoclonal Antibodies
Contact our experts to discuss your Humira biosimilar testing needs.