Methods for identifying and analyzing amino acid sequences of proteins

The disclosure provides methods for determining the biosimilarity of a test protein in relation to a target biologic in which the test protein is digested by two distinct proteases, the resultant digested peptide fragments are analyzed by column chromatography-tandem mass spectrometry to achieve 100...

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Hauptverfasser: LI LINGHUI, XIAO XIAOYAO
Format: Patent
Sprache:chi ; eng
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Zusammenfassung:The disclosure provides methods for determining the biosimilarity of a test protein in relation to a target biologic in which the test protein is digested by two distinct proteases, the resultant digested peptide fragments are analyzed by column chromatography-tandem mass spectrometry to achieve 100% of the amino acid sequence coverage and 100% amino acid sequence accuracy of the test protein. 本公开内容提供用于测定受试蛋白相对于靶标生物制品的生物相似性的方法,其中受试蛋白被两种不同的蛋白酶消化,得到的消化肽片段用柱色谱-串联质谱分析,以达到受试蛋白的100%的氨基酸序列覆盖度和100%的氨基酸序列精确性。