Sedimentation velocity analytical ultracentrifugation for characterization of therapeutic antibodies
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Sedimentation velocity analytical ultracentrifugation (SV-AUC) coupled with direct computational fitting of the observed concentration profiles (sedimentating boundary) have been developed and widely used for the characterization of macromolecules and nanoparticles in solution. In particular, size distribution analysis by SV-AUC has become a reliable and essential approach for the characterization of biopharmaceuticals including therapeutic antibodies. In this review, we describe the importance and advantages of SV-AUC for studying biopharmaceuticals, with an emphasis on strategies for sample preparation, data acquisition, and data analysis. Recent discoveries enabled by AUC with a fluorescence detection system and potential future applications are also discussed.
KeywordsAnalytical ultracentrifugation Sedimentation velocity Biopharmaceuticals Protein Aggregates Immunogenicity
This work was partly supported by the MEXT/JSPS Grants in Aid for Scientific Research (15 K14457, 17H03975) and by grant-in-aid from the Research on Development of New Drugs of AMED.
Compliance with ethical standards
Conflict of interest
Susumu Uchiyama declares that he has no conflicts of interest. Masanori Noda declares that he has no conflicts of interest. Elena Krayukhina declares that she has no conflicts of interest.
This article does not contain any studies with human participants or animals performed by any of the authors.
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