Rapid analytical tryptic mapping of a recombinant chimeric monoclonal antibody and method validation challenges

A rapid and reproducible analytical tryptic mapping method was developed as an identity test for a recombinant chimeric monoclonal antibody for lot release testing. The unfolding, reduction, carboxymethylation, trypsin digestion, and reversed-phase (RP) HPLC steps were optimized to provide a reprodu...

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Veröffentlicht in:	Journal of pharmaceutical and biomedical analysis 1997-12, Vol.16 (4), p.631-640
Hauptverfasser:	Kannan, K, Mulkerrin, M.G, Zhang, M, Gray, R, Steinharter, T, Sewerin, K, Baffi, R, Harris, R, Karunatilake, C
Format:	Artikel
Sprache:	eng
Schlagworte:	Analysis Antibodies, Monoclonal - analysis Biological and medical sciences Buffers Chromatography, High Pressure Liquid - methods General pharmacology Identity Medical sciences Method validation Monoclonal antibody Oxidation-Reduction Peptide Mapping Pharmacology. Drug treatments Recombinant Fusion Proteins - analysis Recombinant protein Reproducibility of Results Reversed-phase HPLC Tosylphenylalanyl Chloromethyl Ketone Trypsin Tryptic mapping
Online-Zugang:	Volltext
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