Labile proteins, such as recombinant enzymes, are typically produced using perfusion cell culture to decrease residence time. In addition, labile proteins are processed downstream at cold temperatures minimizing exposure to enzymatic, chemical, and physical degradation and thereby mitigating product stability risks.  This case study will show the use of innovative strategies to develop a manufacturable downstream process at ambient temperatures for these relatively unstable target proteins. This strategy included use of an integrated continuous capture process.  A unique approach was developed to enhance the robustness of the continuous capture process, which required the evaluation of multiple process parameters. Several chemistries (HIC, multi-modal, IEX) were screened for the post capture purification process, including membrane chromatography. The development of the ambient downstream manufacturing process was facilitated by the optimization of the process sequence and the utilization of membrane chromatography.

Downstream process development for a recombinant enzyme molecule with continuous capture

247th National Meeting (2014)

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