Not available outside of the UK & Ireland.

Application

For research use only. Not for use in diagnostic procedures.

General description

A Protein Conformational Array (PCA) in a sandwich ELISA format where the plate is coated with a panel of antibodies raised against peptides derived from the full length protein sequence of Denosumab. Taken individually, each of these antibodies is strongly antigenic to the peptide sequence that was used in its production. However, when these peptides are incorporated into a full length correctly folded protein, the antigenicity of many of them is masked by the three dimensional structure of the protein and a basal level of epitopes are detected by this assay. The result is a histogram which can be likened to a ‘;fingerprint’; for correctly folded Denosumab. For an Denosumab Biosimilar, if the protein is correctly folded and modified, the ‘;fingerprint’; will match that of Denosumab. If it is not correctly folded, previously masked peptide sequences will be exposed and will be recognized by the antibody made to that exposed sequence. In this way, changes in the ‘;fingerprint’; generated by the ELISA will point out differences between the Biosimilar and authentic Denosumab.

Other Notes

ELISA kit contains 3 96-well microplates and all the components necessary to complete an ELISA test.