A single‐use purification process for the production of a monoclonal antibody produced in a PER.C6 human cell line

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<jats:title>Abstract</jats:title><jats:p>Advances in single‐use technologies can enable greater speed, flexibility, and a smaller footprint for multi‐product production facilities, such as at a contract manufacturer. Recent efforts in the area of cell line and media optimization have resulted in bioreactor productivities that exceed 8 g/L in fed‐batch processes or 25 g/L in high‐density cell culture processes. In combination with the development of single‐use stirred tank bioreactors with larger working volumes, these intensified upstream processes can now be fit into a single‐use manufacturing setting. Contrary to these upstream advances, downstream single‐use technologies have been slower to follow, mostly limited by low capacity, high cost, and poor scalability. In this study we describe a downstream process based solely on single‐use technologies that meets the challenges posed by expression of a mAb (IgG<jats:sub>1</jats:sub>) in a high‐density suspension culture of PER.C6® cells. The cell culture harvest was clarified by enhanced cell settling (ECS™) and depth filtration. Precipitation was used for crude purification of the mAb. A high capacity chromatographic membrane was then used in bind/elute mode, followed by two membranes in flow‐through (FT) mode for polishing. A proof of concept of the entire disposable process was completed for two different scales of the purification train.</jats:p>

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