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Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System
JoVE Journal
Bioengineering
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JoVE Journal Bioengineering
Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System

Purification and Analytics of a Monoclonal Antibody from Chinese Hamster Ovary Cells Using an Automated Microbioreactor System

DOI:
10.3791/58947-v

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10:50 min

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May 01, 2019

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, , , , , , ,
1Center for Drug Evaluation and Research, Office of Product Quality, Office of Biotechnology Products, Division of Biotechnology Review and Research II,U.S. Food and Drug Administration

Chapters

  • 00:04Title
  • 00:39Antibody Purification
  • 01:49Purified Antibody Concentration
  • 02:33N-Glycan Labeling and Isolation
  • 05:00Labeled N-Glycan Liquid Chromatography-Mass Spectrometry (LC-MS) Analysis
  • 06:17Charge Variant Sample Preparation
  • 07:38Charge Variant Chip Preparation
  • 08:31Results: Representative Purified Monoclonal Antibody Automated Microbioreactor System Analyses
  • 09:58Conclusion

Summary

Automatic Translation

Automatic Translation

A detailed protocol for the purification and subsequent analysis of a monoclonal antibody from harvested cell culture fluid (HCCF) of automated microbioreactors has been described. Use of analytics to determine critical quality attributes (CQAs) and maximizing limited sample volume to extract vital information is also presented.

Tags

Keywords: Monoclonal AntibodyChinese Hamster Ovary CellsAutomated Microbioreactor SystemPurificationAnalyticsCritical Quality AttributesN-glycan LabelingLiquid Chromatography Mass Spectrometry (LC-MS)

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