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Denovo Biolabs is developing Immunogenicity kits for Pharmaceuticals and Biotechnology companies in accordance with specific EMA and FDA guidelines.

A standard immunogenicity assessment testing strategy is principally composed of two methods; a binding assay which detects the binding antibodies and a cell based method which detects the antibodies that neutralises the biological activity of the recombinant protein drug (neutralising anti-drug antibodies). Additional assays are also required to determine the antibody type in any given samples that are found to be positive. The basic binding anti-drug antibody assay and basic neutralising anti-drug antibody assay methods requires various adaptations, depending upon the number of individual samples that require assessment, to allow sample analysis to be performed in the tiered manner required by the regulators (reference: Guidance for Industry : Assay Development for Immunogenicity Testing of Therapeutic Proteins).

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