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3M™ Harvest RC Centrate Chromatographic Clarifier

SolventumAvailable: Worldwide

3M™ Harvest RC Centrate Chromatographic Clarifier is a single stage single-use chromatographic clarification solution designed to effectively clarify modern cell culture centrates. Centrate clarification using 3M™ Harvest RC Centrate Chromatographic Clarifier may provide many benefits including process compression, high product recovery, and improved process economics.

Solventum

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Description

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.

Key features and benefits:

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

Scalable chromatographic clarification platform for mAb manufacturing in CHO systems

As CHO-based processes for recombinant proteins continue to have increased cell densities and titers, the need for advancement in clarification technologies is of importance to enable manufacturing scalability. A novel technology, anion exchange (AEX) fiber chromatography, aims to address this challenge and has proven to be scalable up to large commercial manufacturing. This approach combines the ease of filter-like flowthrough operation and scalability, as well as the separation precision of chromatography.

Join Dr. Masa Nakamura, Senior Application Development Specialist, Solventum, as he showcases a new clarification platform strategy that can offer seamless implementation and deployment from discovery to clinical and commercial manufacturing. It can also provide consistent and high-quality clarified fluid to enhance commercialization productivity.

Key learning objectives

  • Learn about the application of synthetic fiber chromatography to the clarification unit operation
  • Explore a novel approach to harvest and clarification in CHO processes
  • Understand options to overcome scale up challenges and to reduce soluble impurities during clarification

Who should attend?

  • Scientists, Engineers, and Heads of process development, manufacturing, MSAT, and CMC from biopharmaceutical organizations focused on recombinant protein production in CHO expression systems.

Certificate of attendance
All webinar participants can request a certificate of attendance, including a learning outcomes summary, for continuing education purposes


The future of clarification processes

Dr. Alexei Voloshin, Global Head of Bioprocess Science at Solventum, discusses the need for advanced clarification processes in product development. He introduces the 3M Harvest RC Chromatographic Clarifier and 3M Harvest RC Centrate Chromatographic Clarifier, designed to separate soluble and insoluble impurities effectively. The 3M Harvest RC Chromatographic Clarifier platform also enhances process development and addresses challenges faced by biologics producers. Elliott Zell, Global New Product Marketing Manager at Solventum, emphasizes the importance of understanding customer needs and the speed of bringing new products to market.


Clarify CHO cell cultures in a single step with 3M™ Harvest RC Chromatographic Clarifier platform

Kuan-Yin Lin, Product Development Specialist at Solventum, describes the features of the 3M™ Harvest RC Chromatographic Clarifier and the 3M™ Harvest RC Centrate Chromatographic Clarifier. This platform of chromatographic solutions enables the clarification of CHO cell cultures and centrates in a single step. These technologies provide a new dimension of clarification capability by incorporating a functionalized anion exchange media to improve separation fidelity. Hear how Solventum is reinventing CHO clarification and improving speed to market with its chromatographic clarification platform approach.


Enhancing productivity and sustainability in bioprocessing

Dr. Alexei Voloshin, Global Head of Bioprocess Science at Solventum, discusses the critical role of innovation in bioprocessing. He highlights the industry's need for increased productivity and the importance of advanced separation technologies. By retooling old manufacturing processes and developing new strategies, the future of bioprocessing aims to be more efficient and sustainable, using fewer resources while improving access to medicines in resource-limited areas.


The future of biopharma clarification with 3M Harvest RC Centrate Chromatographic Clarifier

Leveraging advanced material science technology, the 3M™ Harvest RC Centrate Chromatographic Clarifier is a range of high capacity single-use synthetic chromatographic clarification products. Harvest RC Centrate enables you to remove more impurities earlier in the process to benefit from downstream efficiencies later. Explore how the Harvest RC Centrate offers superior impurity removal for superior fluid quality, including DNA reduction to <500 ppb.


Simplify recombinant protein harvest and clarification processes with a unified solution platform

Recombinant protein harvest and clarification unit operations are increasingly challenged with higher cell densities, newer and more complex therapeutic modalities, and the need to rapidly scale up and down. The 3M™ Harvest RC Chromatographic Clarifier platform is a scalable clarification platform that offers consistent and comparable clarified fluid quality across the platform. Discover how the platform achieves enhanced product recovery to >95%, and superior impurity removal to <500 ppb DNA.



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