BioPharmaSpec provides a complete solution for Etanercept/ Enbrel comparability, biosimilarity and characterization studies.
Etanercept (trade name Enbrel) is a recombinant protein made by fusing the TNF-receptor and the constant region of the IgG1 antibody. It is a large biopharmaceutical with a molecular weight of 150 kDa that, similar to Humira, Simponi and Remicade, inhibits tumor necrosis factor alpha (TNFα). TNFα is central to the inflammatory response and plays a major role in inflammatory/ autoimmune diseases such as arthritis, plaque psoriasis and ankylosing spondylitis. Etanercept is therefore used to treat certain inflammatory diseases.
Biosimilar Characterization Considerations
The guidelines state that Etanercept/ Enbrel comparability and characterization should include determination of physicochemical and structural properties, purity, impurities and quantity in line with ICH Topic Q6B:
Structural Characterization
Physicochemical Characterization
Functional Testing by Custom Biologics
- Caspase 3/Apoptosis Assay
- NFkB Reporter Assay
- TNFα Neutralization Assay
- Antibody-Dependent Cell Cytotoxicity (ADCC) Reporter Bioassay
- Complement-Dependent Cytotoxicity (CDC) Assay
- Proliferation Assays
- Binding Assays
- ELISA
- BLI
Product Specific Technical Considerations
Particular attention should be paid to the Post Translational Modifications (PTMs) including:
- Disulfide bridges (particularly in the TNFα region)
- C-terminal Lysine
- Glycosylation (in particular, levels of galactosylation, fucosylation and sialylation, N-glycosylation site profiling and occupancy and O-glycosylation structure and site occupancy).
- Deamidation
- Oxidation
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BioPharmaSpec scientists have provided data to support many biosimilar development programs for our global client base. Contact our scientists now to understand how we can use our protein characterization methods to accelerate the development of your molecule.