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 Bevacizumab. 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 Bevacizumab. For an Avastin Biosimilar, if the protein is correctly folded and glycosylated, the ′fingerprint′ will match that of Bevacizumab. 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 Bevacizumab.
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For research use only. Not for use in diagnostic procedures.
Frontiers in pharmacology, 4, 103-103 (2013-08-24)
Antibody arrays were developed to probe a monoclonal antibody's three-dimensional structure (3-D structure). Peptides with overlapping regions were designed to cover the whole mAb light chain and heavy chain, respectively, and used to generate polyclonal antibodies after the conjugation of
Biosimilar mAb in-process Sample Higher Order Structure Analysis with Protein Conformational Array ELISA.
Michael Davies, Gan Wang, Jian Gong, Guofeng Fu and Xing Wang
The elucidation of antibody higher order structure (HOS) is critical in therapeutic antibody development. Since HOS determines the protein bioactivity and chemo-physical properties, this knowledge can help to ensure that the safety and efficacy attributes are not compromised. Protein conformational
Remsima (infliximab) was recently approved as the world's first biosimilar monoclonal antibody (mAb) in both the European Union and Korea. To achieve this, extensive physicochemical characterization of Remsima in relation to Remicade was conducted in order to demonstrate the highly
Monoclonal antibodies (mAbs) lead biologics growth, predicted $125 billion worldwide sales by 2020, emphasizing their therapeutic significance.
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