Advances in mammalian cell line development technologies for recombinant protein production
From 2006 to 2011, an average of 15 novel recombinant protein therapeutics have been approved by US Food and Drug Administration (FDA) annually. In addition, the expiration of blockbuster biologics has also spurred the emergence of biosimilars. The increasing numbers of innovator biologic products a...
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sg-ntu-dr.10356-984842023-12-29T06:46:20Z Advances in mammalian cell line development technologies for recombinant protein production Lai, Tingfeng Yang, Yuansheng Ng, Say Kong School of Chemical and Biomedical Engineering DRNTU::Science::Medicine::Pharmacy::Pharmaceutical technology From 2006 to 2011, an average of 15 novel recombinant protein therapeutics have been approved by US Food and Drug Administration (FDA) annually. In addition, the expiration of blockbuster biologics has also spurred the emergence of biosimilars. The increasing numbers of innovator biologic products and biosimilars have thus fuelled the demand of production cell lines with high productivity. Currently, mammalian cell line development technologies used by most biopharmaceutical companies are based on either the methotrexate (MTX) amplification technology or the glutamine synthetase (GS) system. With both systems, the cell clones obtained are highly heterogeneous, as a result of random genome integration by the gene of interest and the gene amplification process. Consequently, large numbers of cell clones have to be screened to identify rare stable high producer cell clones. As such, the cell line development process typically requires 6 to 12 months and is a time, capital and labour intensive process. This article reviews established advances in protein expression and clone screening which are the core technologies in mammalian cell line development. Advancements in these component technologies are vital to improve the speed and efficiency of generating robust and highly productive cell line for large scale production of protein therapeutics. Published version 2014-01-10T01:16:36Z 2019-12-06T19:55:50Z 2014-01-10T01:16:36Z 2019-12-06T19:55:50Z 2013 2013 Journal Article Lai, T., Yang, Y., & Ng, S. K. (2013). Advances in mammalian cell line development technologies for recombinant protein production. Pharmaceuticals, 6(5), 579-603. 1424-8247 https://hdl.handle.net/10356/98484 http://hdl.handle.net/10220/18419 10.3390/ph6050579 24276168 en Pharmaceuticals © 2013 The Authors (published by MDPI). This paper was published in Pharmaceuticals and is made available as an electronic reprint (preprint) with permission of the authors. The paper can be found at the following official DOI: [http://dx.doi.org/10.3390/ph6050579]. One print or electronic copy may be made for personal use only. Systematic or multiple reproduction, distribution to multiple locations via electronic or other means, duplication of any material in this paper for a fee or for commercial purposes, or modification of the content of the paper is prohibited and is subject to penalties under law. application/pdf |
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DRNTU::Science::Medicine::Pharmacy::Pharmaceutical technology Lai, Tingfeng Yang, Yuansheng Ng, Say Kong Advances in mammalian cell line development technologies for recombinant protein production |
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From 2006 to 2011, an average of 15 novel recombinant protein therapeutics have been approved by US Food and Drug Administration (FDA) annually. In addition, the expiration of blockbuster biologics has also spurred the emergence of biosimilars. The increasing numbers of innovator biologic products and biosimilars have thus fuelled the demand of production cell lines with high productivity. Currently, mammalian cell line development technologies used by most biopharmaceutical companies are based on either the methotrexate (MTX) amplification technology or the glutamine synthetase (GS) system. With both systems, the cell clones obtained are highly heterogeneous, as a result of random genome integration by the gene of interest and the gene amplification process. Consequently, large numbers of cell clones have to be screened to identify rare stable high producer cell clones. As such, the cell line development process typically requires 6 to 12 months and is a time, capital and labour intensive process. This article reviews established advances in protein expression and clone screening which are the core technologies in mammalian cell line development. Advancements in these component technologies are vital to improve the speed and efficiency of generating robust and highly productive cell line for large scale production of protein therapeutics. |
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School of Chemical and Biomedical Engineering |
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School of Chemical and Biomedical Engineering Lai, Tingfeng Yang, Yuansheng Ng, Say Kong |
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Article |
author |
Lai, Tingfeng Yang, Yuansheng Ng, Say Kong |
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Lai, Tingfeng |
title |
Advances in mammalian cell line development technologies for recombinant protein production |
title_short |
Advances in mammalian cell line development technologies for recombinant protein production |
title_full |
Advances in mammalian cell line development technologies for recombinant protein production |
title_fullStr |
Advances in mammalian cell line development technologies for recombinant protein production |
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Advances in mammalian cell line development technologies for recombinant protein production |
title_sort |
advances in mammalian cell line development technologies for recombinant protein production |
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2014 |
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https://hdl.handle.net/10356/98484 http://hdl.handle.net/10220/18419 |
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