Step into the future with our advanced fiber chromatographic technology to help streamline your process.
As you work with higher density cell cultures providing higher titers in your biopharmaceutical manufacturing processes, your ability to harvest cell culture consistently and effectively becomes more challenging. 3M’s anion exchange (AEX) single-use fiber chromatographic clarification solutions can help streamline your production process.
Read about challenges and unmet needs with current harvest technologies from leaders in biopharmaceutical manufacturing. As technology developers learn more about these unmet needs, they can introduce new solutions that can bring cost savings that are significant enough to be worth investment and justify implementation.
Clarification is a critical unit operation in the production of mAbs and recombinant proteins because it directly affects yield, product consistency and performance of downstream unit operations. 3M created a novel purification method by filtering with charge rather than by particle size. The media is designed with a synthetic nonwoven material containing quaternary amine grafted fibers, which can remove more impurities than traditional depth filters.
Large contaminants such as cells and cell debris, plus small insoluble and soluble impurities like DNA and HCP, can be removed at this early stage. Enabling a higher purity earlier in the purification process makes downstream processing easier.
Viewed with a scanning electron microscopy (SEM), cells can be seen adsorbed and captured throughout the matrix of the functional nonwoven bed of 3M™ Harvest RC Chromatographic Clarifier.
AEX fibrous functional media can effectively capture cells, cell debris, DNA and HCP that are negatively charged at the harvest cell culture pH. Therefore, the positively charged molecule of interest can flow through.
This study, “Enabling Process Simplification through Chromatographic Clarification with High Titer Cell Culture,” was completed by Thermo Fisher Scientific.
In the study, we illustrated that using the 3M™ Harvest RC could result in highly clean filtrate with a single stage allowing for a simplified process development and process set-up. This single-stage set-up also resulted in improved yield compared to traditional multiple-stage set-up that would translate to product loss.
See how 3M™ Harvest RC Chromatographic Clarifier compares as a single-stage single use platform for harvest and clarification.
Read the peer-reviewed paper: Chromatographic capture of cells to achieve single stage clarification in recombinant protein purification.
3M collaborated with Polpharma Biologics for this study, “DNA impurity removal at the clarification stage is the key to mAb purification process efficiency improvement.”
This study demonstrated that host cell DNA-related impurities such as chromatin interfere with the protein A capture step and removal before the capture step can significantly increase performance and robustness of Protein A capture chromatography.
3M™ Emphaze™ AEX Hybrid Purifier can address the challenge of the soluble DNA impurities and reduction of host cell proteins (HCPs).
To learn more about the importance of Protein A capture chromatography in the purification of monoclonal antibodies, read: Chromatographic clarification overcomes chromatin-mediated hitch-hiking interactions on Protein A capture column.
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One step can transform your mAb and recombinant protein manufacturing process. At 3M, we’re helping build better, more efficient and simpler manufacturing processes by developing solutions to enhance biologic drug recovery that leads to improved process economics.