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| Monoclone Selection and Monoclonal Verification of Engineering Cell Lines |
Yi-fan JIANG( ),Jing DONG,Jing-shuang WEI |
| New Drug Research and Development Company Limited, North China Pharmaceutical Corporation, State Key Laboratory of Antibody Drug Development, Shijiazhuang 050015, China |
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Abstract The monoclonality of recombinant cell lines is one of the important factors to ensure the quality of the product, so it has received more and more attention. Currently, some drug regulatory agencies require the application organization to demonstrate the monoclonality of the cells via appropriate experimental. The process and common methods (such as limiting dilution cloning, ClonePix, and fluorescent-activated cell sorting) for the clone selection of engineering cell lines for production were introduced.How to ensure the monoclonal of engineering cell, and the significance of engineering monoclonal in the production of the biological drug were discussed.
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Received: 11 October 2018
Published: 08 May 2019
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Corresponding Authors:
Yi-fan JIANG
E-mail: jyifan@126.com
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