Toward best practices in data processing and analysis for intact biotherapeutics by MS in quantitative bioanalysis.
作者： John F Kellie , Jonathan R Kehler , Molly Z Karlinsey , Scott G Summerfield
关键词:
摘要: Aim: Typically, quantitation of biotherapeutics from biological matrices by LC–MS is based on a surrogate peptide approach to determine molecule concentration. Recent efforts have focused the intact protein molecules or larger mass subunits monoclonal antibodies. To date, there has been limited guidance for large quantitative bioanalysis. Methodology: Intact- and subunit-level analyses are performed at 12–25 kDa range with data presented. Results: Linearity, bias other metrics presented along recommendations made viability existing approaches. Conclusion: This communication intended start discussion around analysis processing, recognizing that published contributions will be required.
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