ICH guidelines Q8-11 describe the different QbD elements and regulatory expectations to files for new biopharmaceuticals. Key QbD elements are the linking of QTPP, CQAs, CPPs and control strategies, the risk-based approach, and the theoretical and experimental design to obtain optimal process understanding. All of these elements were applied to specific unit operations of a late stage haemostasis protein to obtain optimal flexibility, and the approaches have been discussed with regulatory authorities (FDA, EMA, PMDA, and Health Canada). The unit operations are: 1) a reaction step using a mechanistic model for process understanding and control combined with a chip-based PAT methodology for feed-forward control of this process step; and 2) a freeze-drying step using a reduced DoE approach for process understanding combined with a pressure-rise test for feed-back control. Quality risk management was handled through a combination of QFD (Quality Function Deployment) and a company developed risk assessment tool. This paper will present experiences gained from the authority meetings, including expectations to documentation and process understanding filing strategies towards authorities outside ICH.

Implementation of unit operation design spaces: Experiences with regulatory authorities

245th National Meeting (2013)

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