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| The Lasted Development of Large Scale Cell Culture Technology for Commercial Antibody Manufacture |
| LIU Bo-ning |
| New Drug Reaserch and Development Center, North China Pharmaceutical Group Corporation and State Key Laboratory of Antibody drug Reaserch and Development, Shijiazhuang 050015, China |
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Abstract Large scale animal cell culture technology has leaped forward in the lasted years. The state-of-art of cell culture process development for commercial monoclonal antibody production, which is involved with medium optimization methodology and process development of fed batch/perfusion mode, was discussed in detail. Some methods and compositions used for improving recombinant yield and impact of cell culture process on critical quality attribute of recombinant antibody (such as: aggregate、degradation、glycosylation, charge heterogeneity)were summarized and illustrated by cases. Additional, some topic involved with cGMP manufacturing was addressed, including process characterization and validation. It can been forecasted that the omics research of animal cell and PAT (process analysis technology) will accelerate process development of large scale cell culture.
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Received: 07 April 2013
Published: 25 July 2013
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