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TitleGuidelines to cell engineering for monoclonal antibody production
Author(s)Costa, A. R
Rodrigues, E.
Henriques, Mariana
Azeredo, Joana
Oliveira, Rosário
KeywordsMonoclonal antibody
Mammalian cells
Cell engineering
Transfection methods
Vector design
Clone selection
Cell adaptation
Productivity enhancement
Issue date2010
JournalEuropean Journal of Pharmaceutics and Biopharmaceutics
Citation"European Journal of Pharmaceutics and Biopharmaceutics". ISSN V. 74:2 (21010) 127-138.
Abstract(s)Monoclonal antibodies (mAbs) are currently used for many diagnostic and therapeutic applications. The high demand for these biopharmaceuticals has led to the development of large-scale manufacturing processes, with productivity improvements being mainly achieved by optimization of bioreactor systems. However, more recently, the early steps of production, previous to bioreactor culture, have been presented as alternative areas where productivity enhancements can be achieved. Thus, this review describes the progress made for the improvement of productivity in mammalian expression systems for the high production of mAbs. Advances in the development of mAb-producing cell lines are being made, particularly regarding expression vector design and methods used for transfection, with the intent to create a reproducible methodology. Selection of the most suitable clones is also a critical step that can be improved, by including variables other than the expression level, which is still the common practice. Furthermore, strategies of cell engineering, although still mostly based on trial-and-error experimentation and not in standard protocols, hold great interest to improve cell growth and productivity, as well as product quality in the future. Improvements of the initial steps of the production process would not only result in cells with higher expression ability, but would also speed-up the process development.
Appears in Collections:CEB - Publicações em Revistas/Séries Internacionais / Publications in International Journals/Series

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