Peptide Mapping: A Quality by Design (QbD) Approach
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چکیده
Peptide mapping is a widely used technique for the characterization of proteins. This Application Note demonstrates a robust LC method and design space for peptide mapping using a Quality by Design (QbD) approach. A therapeutic monoclonal antibody (mAb) was employed as the model protein in the current peptide mapping study. Fusion QbD software’s multivariate design and analysis capabilities, which are aligned with a QbD approach, in combination with its OpenLAB CDS experiment automation capabilities, provided a detailed understanding of the critical method parameter (CMP) effects on the various critical method attributes (CMAs) included in the study. This knowledge was translated directly into a robust final peptide mapping method with maximum number of peaks and good separation in far less method development time.
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Peptide Mapping: A Quality by Design (QbD) Approach
Peptide mapping is a widely used technique for the characterization of proteins. This Application Note demonstrates a robust LC method and design space for peptide mapping using a Quality by Design (QbD) approach. A therapeutic monoclonal antibody (mAb) was employed as the model protein in the current peptide mapping study. Fusion QbD software’s multivariate design and analysis capabilities, wh...
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