Next Generation Solution to Increase mAb Yields and Streamline
the Clarification Process
The first step in the recombinant biotherapeutic process is harvesting the cell culture that contains the product. Traditional methods for this step use a combination of depth filtration, centrifugation, and membrane filtration, which leverage differences in density and size as the principles of separation. However, as cell culture processes are scaled up to achieve higher cell densities and product titers, the challenge of maintaining a consistent and scalable harvesting performance deepens.
To overcome these limitations and achieve a step-change in performance, a radically different approach is proposed. Instead of separating the cell culture mixture based on size or density, differences in charge can be exploited. Whole cells, cell debris as well as other impurities like chromatin, DNA and subsets of host cell proteins
are negatively charged under normal cell culture conditions. The cell mass and impurities can be retained on a positively charged matrix, while the protein of interest flows through. This is exactly how 3MTM Harvest RC Chromatographic Clarifier operates.
3M™ Harvest RC Chromatographic Clarifier provides a chromatographic separation approach for Chinese Hamster Ovary (CHO) cell cultures. This groundbreaking solution enables a single stage and fully encapsulated operation, replacing the multi-stage centrifugation and depth filtration steps that are traditionally associated with cell culture clarification.
The separation media is based on innovative functionalized fiber-technology, combined with a 0.2µm polyether sulfone (PES) membrane. An open structure of precision quaternary ammonium (Q) functionalized fibers captures cells and cell debris at a very effective bed utilization. The anion exchange (AEX) media retains large particles and small impurities simultaneously, which results in a cleaner effluent than centrifugation or depth filtration. High target protein recoveries of > 95% are typically achieved, and these are consistent across the different capsule sizes.
The single stage chromatographic approach offers predictable performance and robust scalability across all scales from discovery to full scale commercial manufacturing. A low differential pressure during clarification ensures low cell shear and avoids the associated downstream impurity challenges, even at the largest scales.
Easy-to-use and fast solutions are available for laboratory operations. At the very small scales, well-plate and conical tube designs can be used in combination with high-throughput screening bioreactors, to offer a fast-screening approach for 15 mL volumes.
These lab-scale solutions can be used for screening purposes or just fast sample processing for downstream studies. The lab devices offer similar impurity removal and a product purity that is comparable to the larger capsules, providing a seamless transition between the lab and pilot or manufacturing scales.
3MTM Harvest RC Chromatographic Clarifier offers:
Simplified single stage operation for cell culture fluid clarification.
Consistent scaling from discovery to manufacturing.
Predictable and reliable performance for turbidity and impurity reduction.
High product recovery above 95%.
Lower total manufacturing cost compared to centrifugation and depth filtration.
These advantages make 3M™ Harvest RC Chromatographic Clarifier a vital addition to the field of biopharmaceutical manufacturing.
Ready to discover how 3M™ Harvest RC Chromatographic Clarifier can help transform your recombinant protein therapeutic manufacturing? Download 3M's brochure.
