Single-stage chromatographic purification for recombinant protein therapeutic manufacturing.

• High mAb product recovery (capsules: >95%; conical tube and well plate >90%)
• Consistent cell loading capacity
• Turbidity reduction (<15 NTU)
• TDNA reduction (<500 ppb)
• Minimal cell shear
• 0,1 μm sterile filter protection

The first step in the recombinant biotherapeutic process is harvesting cell culture fluid containing the product. Conventional approaches for performing this unit operation utilise a combination of depth filtration, centrifugation and membrane filtration. These technologies utilise differences in density and in size to yield higher cell densities and product titers, the ability to effectively harvest the cell culture fluid with the consistency and scalability required becomes challenging.

3M Harvest RC is a harvest solution that utilises fibrous anion exchange (AEX) chromatography to efficiently separate the cells, cell debris and DNA from the harvest fluid containing the target product. Precision quaternary ammonium (Q) functionalised polypropylene fiber, combined with a 0,2 µm PES membrane, provides scalable and predictable clarification from discovery to commercial manufacturing scale.

3M™ Harvest RC chromatographic clarifier encapsulates innovative synthetic fibrous anion exchange (AEX) chromatography media and a 0,2 µm polyether sulfone (PES) membrane. This enables a single-stage clarification process of low to high-density cell culture (>40 million cells per ml) with high product recovery and high fidelity of soluble and insoluble contaminant separation.

Cells are bound inside the media by electrostatic charge interaction with the AEX chromatographic fibers. This results in the efficient retention of large and small particulates without developing a surface cake layer. The media can also remove soluble impurities which results in cleaner effluent than centrifugation or depth filtration.