Advances in mammalian cell line development technologies for recombinant protein production
Autor: | Yuansheng Yang, Tingfeng Lai, Say Kong Ng |
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Přispěvatelé: | School of Chemical and Biomedical Engineering |
Jazyk: | angličtina |
Rok vydání: | 2013 |
Předmět: |
Cell
cell line development Pharmaceutical Science lcsh:Medicine lcsh:RS1-441 Review Genome lcsh:Pharmacy and materia medica Mammalian cell Drug Discovery medicine clone screening Gene protein expression business.industry lcsh:R Biosimilar Biotechnology biopharmaceutical production Biopharmaceutical medicine.anatomical_structure Cell culture Science::Medicine::Pharmacy::Pharmaceutical technology [DRNTU] Molecular Medicine Clone (B-cell biology) business |
Zdroj: | Pharmaceuticals Pharmaceuticals, Vol 6, Iss 5, Pp 579-603 (2013) |
Popis: | 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 |
Databáze: | OpenAIRE |
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