BioOutsource offers a comprehensive range of services to support the biological evaluation of Humira including characterisation, comparability and biosimilarity. 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.
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.
Humira (Adalimumab) is a fully humanised 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.
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 provides cutting edge methodologies using a range of novel cell lines allowing end to end support for Humira biosimilar manufacturers. We have extensive experience, working with over 10 different Humira biosimilar products across the clinical phases:
- Biosafety Testing for monoclonal antibodies
- Humira Binding Assays
- Humira Bioassays
- Humira Physicochemical Assays
Contact our experts to discuss your Humira biosimilar testing needs.