Biosimilar Characterization Considerations
BioPharmaSpec provides a complete solution for Infliximab/ Remsima/ Inflectra/ Remicade comparability, biosimilarity and characterization studies.
Infliximab (trade names Remicade/ Remsima/ Inflectra) is a chimeric monoclonal antibody, meaning it is a combination of mouse and human antibody amino acid sequences. Similar to Enbrel and Humira, Infliximab targets tumor necrosis factor alpha (TNF-α) and is used to treat autoimmune diseases such as Crohn’s disease, ulcerative colitis, psoriasis, ankylosing spondylitis, and arthritis.
Remsima/ Inflectra became the first biosimilar monoclonal antibody to be approved by the EMA and FDA, with the notes from these regulatory submissions (i.e. comparability to Remicade in terms of safety, efficacy and quality) providing valuable guidance for other biosimilar developers.
The guidelines state that Infliximab/ Remsima/ Inflectra/ Remicade comparability and characterization studies should include determination of physicochemical and structural properties, purity, impurities and quantity in line with ICH Topic Q6B:
Functional Testing by Custom Biologics
- Cell Proliferation Assays
- TNFα Neutralization Assay
- Antibody-dependent cell cytotoxicity (ADCC) Reporter Bioassay
- Complement-dependent Cytotoxicity (CDC) Assays
- Binding Assays– TNFα, Fc-Receptors, C1q, FcRn
Product Specific Technical Considerations
Particular attention should be paid to the Post Translational Modifications (PTMs) including:
- Levels of Pyroglutamination
- Disulfide bridges
- Heavy chain C-terminal Lysine
- Glycosylation (in particular, levels of galactosylation and fucosylation)
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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.