Cell culture fluid harvesting has gone through a number of generations of approaches and technologies that implement different strategies. While several different principles have been proposed and evaluated by the industry, only two have seen deployment on a wide scale in the biopharma industry. Separation of large particles by density using a centrifuge and the cleanup of small particles through the use of depth and membrane filtration continues to be the tried-and-true approach in laboratories and manufacturing facilities worldwide. Yet, growing cell densities, increase in the difficulty and in range of cell culture biochemical and biophysical characteristics have exhausted the performance potential of both density and size strategies and of technology that implements them. As the expectations of the performance, robustness, product quality and recovery continue to increase, new separation principles are needed as is scalable technology to bring these principles into a real life process space.<br/>Here we demonstrate a new approach that uses AEX chromatography to enable cell culture fluid clarification using a chromatographic approach. Through the use of advanced non-woven materials and ligand chemistries we have enabled chromatographic separation of particles across the size range from that of mammalian cells to soluble small molecules. The result is the ability to clarify the cell culture, scale the system, and predict the quality of clarification with chromatographic precision and repeatability. This principle effectively bypasses the limitations of the present approaches and offers much higher clarification performance and robustness at the same time. We discuss the basic architecture of such chromatographic supports, scaling characteristics, performance metrics, and robustness of such an approach for deployment across the biopharma industry. Furthermore we demonstrate how this approach is implemented in a scalable single-use technology that is easily deployed at bench scale and commercial manufacturing alike. This approach enables chromatographically defined performance of the purification process from the beginning, thus simplifying the whole purification process and increasing its robustness.<br/>

Next generation clarification approach using chromatography of large particles

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

The official archive and repository for all ACS Meetings & Expositions abstracts and select posters or presentations.