METHOD FOR IDENTIFICATION AND ABSOLUTE QUANTIFICATION OF PRODUCT-RELATED IMPURITIES IN A PROTEIN USING HIGH-RESOLUTION MASS SPECTROMETRY

METHOD FOR IDENTIFICATION AND ABSOLUTE QUANTIFICATION OF PRODUCT-RELATED IMPURITIES IN A PROTEIN USING HIGH-RESOLUTION MASS SPECTROMETRY

The present invention discloses a method for the identification and absolute quantification of peptide based impurities in a protein/antibody composition using high resolution mass spectrometry. The method utilizes synthetic peptides for plotting a standard calibration curve which is, in turn, used...

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Bibliographische Detailangaben
Hauptverfasser: SHRINEWAR, Vishal Balu, SETTY, Rakesh Komarla Sathyanarayana, JAYARAMAN, Murali, BHARATI, Avinash, CHANDINI, Sakthi Deivanayagam
Format: Patent
Sprache:eng
Schlagworte:
INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES
MEASURING
PHYSICS
TESTING
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Beschreibung
Zusammenfassung:The present invention discloses a method for the identification and absolute quantification of peptide based impurities in a protein/antibody composition using high resolution mass spectrometry. The method utilizes synthetic peptides for plotting a standard calibration curve which is, in turn, used for the absolute quantification of the impurities. In particular, the method is utilized for quantification of signal peptide remnants in heterogeneous unpurified or partially purified protein samples, comprising a complex mixture of proteins, with high sensitivity using unlabeled synthetic peptides.