Importance of vial shape and type on the reproducibility of size exclusion chromatography measurement of monoclonal antibodies
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- 作者：Marta Rodriguez-Allera ; Alessandra Cusumanob ; Beck Alainc ; Davy Guillarmea ; Szabolcs Feketea ; szabolcs.fekete@unige.ch" class="auth_mail" title="E-mail the corresponding author
- 关键词：Monoclonal antibody ; Protein biopharmaceuticals ; Size exclusion chromatography ; Vial ; Insert ; Injection precision
- 刊名：Journal of Chromatography B, Analytical Technologies in the Biomedical and Life Sciences
- 出版年：2016
- 出版时间：1 October 2016
- 年：2016
- 卷：1032
- 期：Complete
- 页码：131-138
- 全文大小：1556 K
文摘
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Phenomenon behind poor injection repeatability of biopharmaceuticals was investigated.
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Adsorption could be minimized with an adequate vial insert model.
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The most critical inserts possessing the narrowest conical shape at the bottom.
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Two-steps type adsorption process occurred in sample vials.