Advanced Development Strategies for Biopharmaceutical Cell Culture Processes

Author(s): Denes Zalai, Aydin Golabgir, Patrick Wechselberger, Akos Putics, Christoph Herwig

Journal Name: Current Pharmaceutical Biotechnology

Volume 16 , Issue 11 , 2015

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The shift from empirical to science-based process development is considered to be a key factor to increase bioprocess performance and to reduce time to market for biopharmaceutical products in the near future. In the last decade, expanding knowledge in systems biology and bioprocess technology has delivered the foundation of the scientific understanding of relationships between process input parameters and process output features. Based on this knowledge, advanced process development approaches can be applied to maximize process performance and to generate process understanding. This review focuses on tools which enable the integration of physiological knowledge into cell culture process development. As a structured approach, the availability and the proposed benefit of the application of these tools are discussed for the subsequent stages of process development. The ultimate aim is to deliver a comprehensive overview of the current role of physiological understanding during cell culture process development from clone selection to the scale-up of advanced control strategies for ensuring process robustness.

Keywords: Biopharmaceuticals, cell physiology, mammalian cell culture, Process Analytical Technology, process development, quality by design.

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Article Details

Year: 2015
Page: [983 - 1001]
Pages: 19
DOI: 10.2174/1389201016666150724100450
Price: $65

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PDF: 63