Quantitation of a PEGylated protein in monkey serum by UHPLC-HRMS using a surrogate disulfide-containing peptide: A new approach to bioanalysis and in vivo stability evaluation of disulfide-rich protein therapeutics
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- 作者：Naiyu Zhenga ; naiyu.zheng@bms.com" class="auth_mail" title="E-mail the corresponding author ; Jianing Zenga ; jianing.zeng@bms.com" class="auth_mail" title="E-mail the corresponding author ; Amy Manneya ; Lakenya Williamsa ; Anne-Franç ; oise Aubrya ; Kimberly Voroninb ; Adela Buzescua ; Yan J. Zhanga ; Alban Allentoffb ; Carrie Xuc ; Hongwu Shend ; 1 ; William Warnerd ; Mark E. Arnolda
- 关键词：UHPLC-HRMS ; PEGylated protein ; Disulfide-containing peptide ; Protein quantitation ; In vivo stability ; Methionine oxidation
- 刊名：Analytica Chimica Acta
- 出版年：2016
- 出版时间：15 April 2016
- 年：2016
- 卷：916
- 期：Complete
- 页码：42-51
- 全文大小：888 K
文摘
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A novel UHPLC-HRMS was developed to quantify a PEGylated protein in serum.
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Two tryptic peptides were sensitively detected by HRMS with single ion monitoring.
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Quantitation of one disulfide-containing peptide allows in vivo stability evaluation.
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The assay was successfully applied to a non-clinical study for stability evaluation.
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The method is applicable to disulfide rich-protein drugs not suited for SRM detection.