Assessing in vivo dynamics of multiple quality attributes from a therapeutic IgG4 monoclonal antibody circulating in cynomolgus monkey.
作者： Yinyin Li , Yu Huang , Janine Ferrant , Yelena Lyubarskaya , Yue (Emma) Zhang
DOI: 10.1080/19420862.2016.1167298
关键词: In vitro 、 Affinity chromatography 、 Biopharmaceutical 、 Quality (business) 、 Peptide sequence 、 Biology 、 Pharmacology 、 Monoclonal antibody 、 In vivo 、 Critical quality attributes
摘要: ABSTRACTCharacterization of biopharmaceutical proteins and assessment understanding the critical quality attributes (CQAs) is a significant part product development routinely performed in vitro. In contrast, systematic analysis vivo not as widespread, although metabolism clearance multiple variants therapeutic administered to non-human primates human subjects may have different impact on safety, efficacy exposure. The major hurdles such studies are usually sample availability technical capability. this study, we used affinity purification coupled with liquid chromatography mass spectrometric digested protein for consistent simultaneous detection full amino acid sequence IgG4 monoclonal antibody, MAB1. This methodology allowed us assess changes all sequence-related modifications MAB1 over duration preclinic...
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