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Bioengineering

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

Article DOI: 10.3791/58947-v • 10:50 min • May 1st, 2019
May 1st, 2019 •
1, 1, 1, 1, 1, 1, 1, 1
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

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요약
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

Purification Analytics Monoclonal Antibody Chinese Hamster Ovary Cells Automated Microbioreactor System Limited Samples Critical Quality Attributes Quality Parameters Software Conical Tubes Flow-through High Salt Wash Harvested Cell Culture Fluid Syringe Injection Port Sample Loop Saved Method Instrument Software Purified Protein Tris Base
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