Single-stage chromatographic clarification for centrate in recombinant protein manufacturing. This single-use, single-stage, synthetic media clarification solution uses anion exchange chromatographic technology for efficient processing of modern cell culture centrates.

• Synthetic, functionalized fibrous media provides effective soluble impurity removal in centrate, including DNA and cell shear related sub-micron particle reduction

  Single-stage centrate clarification for process compression and streamlining of process development

  Predictable performance scalability for consistent clarification at various process scales

  High product recovery (>95%) and high-capacity capsules for improved process economics

  Alkaline-resistant capsules for pre-use sanitization

  Provides comparable effluent quality to 3M™ Harvest RC Chromatographic Clarifier for a modern clarification platform

3M™ Harvest RC Centrate Chromatographic Clarifier encapsulates innovative synthetic fibrous anion exchange (AEX) Q-functional chromatography media combined with an asymmetric Q-functional polyamide membrane with a 0.2 µm qualifying zone. This enables effective single-stage clarification of CHO cell culture centrates produced by conventional and single-use conical plate (e.g., disc stack) centrifuges.

Soluble and insoluble impurities are captured by electrostatic interactions with a positively charged ligand immobilized on fiber matrix, as well as a downstream polyamide membrane. This results in efficient retention of a wide range of particles that have not been effectively separated by centrifugation or are produced by cell shear during centrifugation. Specifically, the anion exchange mechanism enables efficient capture of impurities <0.5 µm that are difficult to capture with traditional depth filtration and membrane filtration.

The innovative synthetic fibrous AEX chromatographic clarification media enables a single-stage centrate clarification from CHO cell cultures with high product recovery and high fidelity of soluble and insoluble impurity removal. Downstream of the fibrous chromatographic clarification media is the 0.2 µm asymmetric Q-functional polyamide membrane which distributes the flow across the AEX media bed and enables protection of downstream sterilizing grade membrane filter. Also, the 0.2 µm functionalized polyamide membrane enables simple process endpoint measurement using pressure reading.

Meets GLP or cGMP requirements, where applicable.