The present work is a case study in applying process intensification principles to purification development of a commercially suitable manufacturing process for a monoclonal antibody at Takeda. A previously developed process for the antibody faced significant challenges such as insufficient impurity removal efficiency and low throughput. Hence, the existing process was intensified to remove impurities more efficiently and establish an economically and environmentally friendly process by increasing the load capacities of each step and reducing the associated number of cycles and buffer consumption demands. In addition, by combining the flow through mode of hydrophobic interaction chromatography with a reduced bed height, resin consumption and operation time were reduced, while impurities were nonetheless removed more efficiently than the existing process. The present result from this study will be used as a basis for a future assessment for a semi continuous interconnected process.

Process intensification of mAb purification for efficient impurity removal

Macromolecular Chemistry: The Second Century

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ACS Spring 2020 National Meeting & Expo

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