The determination of similarity for biosimilars is not only based on the assessment of the degree to which pharmacokinetic and efficacy parameters are equivalent, but also of the relative immunogenicity profiles of the innovator and biosimilar. Somru BioScience offers high quality, sensitive and robust off-the- shelf ELISA kits for the measurement of anti-drug antibodies (i.e. both anti-innovator and anti-biosimilar) in biological matrices. Our assays are designed to minimize the effect of different biological matrices on the performance of the assay while maintaining appropriate levels of sensitivity. In addition to ELISA kits, we also provide specialized reagents (e.g. cell lines, positive controls etc.) and protocols to support the development of cell-based neutralizing antibody assays.
All of our kits have been developed with the long term specific immunogenicity validation guidelines in mind. Our kits are easily adaptable to meet global regulatory guidelines on bioanalytical method validation (e.g. the FDA’s Guidance for Industry: Assay Development and Validation for Immunogenicity Testing of Therapeutic Protein Products, Guideline on Immunogenicity assessment of biotechnology-derived therapeutic proteins).
Our scientists have extensive experience and expertise in developing immunoassays in various platforms for the assessment of immunogenicity. In addition to our off-the- shelf immunoassays, we can develop custom assays to meet you need. Please contact us at firstname.lastname@example.org to inquire about your custom assay development need.