Production of biologics requires multivariate process control to achieve the desired quality target product profile, QTPP. Similarly, the target product quality attributes are multivariate based on protein sequence and post-translational modifications. It is important therefore to map process input variables to the quality attributes and define the process inputs’ operating ranges and control strategies to consistently achieve QTPP. We describe, using examples, how the cell culture ecosystem from raw material sourcing to the control of standard cell culture variables such as pH, dissolved oxygen and nutrient levels can be leveraged to deliver the target product profile. We also show the importance of understanding the strength of individual input variables in influencing key product quality features. Setting appropriate target control values for controlled parameters is necessary to ensure process robustness in a multivariate setting of both process and product quality.

Control of cell culture variables to meet target process and product quality in the production of biologics

253rd National Meeting (2017)

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