The quality by design (QbD) approach to pharmaceutical manufacturing is intended to improve efficiency and product quality through increased process knowledge and a reduction in variability: By operating within defined ranges product quality can be assured.<br/>We have developed a continuous downstream mAb purification process where the critical process parameters were determined through single column DoE.  Here we characterize the downstream purification by operating the process multiple times. This allows us to understand the inherent variability of the purification and the impact that many key features have on the process. These include start up, shut down, column aging and effect of buffer variability. Multi variate data analysis (MVDA) was also performed enabling us to closely monitor the process and identify issues as parameters drift out of specification. By operating this way and by challenging the process with deviations a more fundamental understanding of the purification can be developed. This enables us to further understand critical process parameters and how they affect the critical quality attributes at the whole process level, not just at the individual unit operation level. Using the knowledge gained from these studies we can identify which parameters have the largest impact on the process and which should be controlled within the tightest engineering limits. This enables us to engineer quality into our process.<br/>

Quality by design principles applied to characterization of a continuous downstream mAb purification process

2019 Spring National Meeting

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