Analytical methods for in-depth characterisation of cell culture bioreactors: A case study
Biopharmaceuticals and especially antibodies represent an expanding segment of pharmaceutical drug products. Production processes for this group of complex molecules use biological expression systems such as Chinese hamster ovary (CHO) cells, that are instrumental in their assembly, folding, and pos...
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| Main Authors: | , , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
Elsevier
2025-11-01
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| Series: | Journal of Chromatography Open |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S2772391725000465 |
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| Summary: | Biopharmaceuticals and especially antibodies represent an expanding segment of pharmaceutical drug products. Production processes for this group of complex molecules use biological expression systems such as Chinese hamster ovary (CHO) cells, that are instrumental in their assembly, folding, and post-translational modification. Process development and optimization is challenging due to the complexity of cell culture systems and interdependency of process parameters on product quality attributes. This case study presents newly applied and developed analytical technologies able to monitor the cell culture process to increase the understanding of the interconnection of process parameters and quality attribute relationships in biopharmaceutical production processes. Specifically, a high-performance liquid chromatography (HPLC) -based workflow routinely measures amino acids and other cell culture media component profiles, while a mass spectrometry-based workflow monitors and quantifies changes in expressions of host cell proteins (HCPs) both globally and for individual HCP during the culture duration. These methods were applied to an industrial process with variations in seeding density, glucose and media feeding strategy, and media composition. Observations on product titre, global HCP and individual high-risk HCPs, throughout the culture progress, as well as in the end of the culture, provide insight for potential further optimization. |
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| ISSN: | 2772-3917 |