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 Palivizumab. 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 only a limited number of the antibodies respond. The result is a histogram which can be likened to a ‘fingerprint′ for correctly folded Palivizumab. For a Synagis Biosimilar, if the protein is correctly folded and glycosylated, the ‘fingerprint′ will match that of Palivizumab. 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 Palivizumab.
Application
For research use only. Not for use in diagnostic procedures.
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