A next-generation clarification solution for the increasing demands of bioprocessing
Biopharmaceutical clarification processes are increasingly challenged with demands for higher cell densities, larger portfolios of modalities, and the need for scalable clarification solutions. What's more, all of these challenges must be addressed to increase speed to market while still delivering a high-quality drug product.
Utilizing our expertise in material science, we've engineered an advanced solution that can help simplify your clarification processes:
3M™ Harvest RC Chromatographic Clarifier platform.
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3M™ Harvest RC Chromatographic Clarifier platform: Two solutions, one platform
Now you can rely on one consistent, scalable clarification platform for all development phases and process volumes.
3M™ Harvest RC
Chromatographic
Clarifier
Direct clarification
3M™ Harvest RC Centrate
Chromatographic Clarifier
Centrate clarification
This one robust clarification platform includes 3M™ Harvest RC Chromatographic Clarifier- a direct clarification solution, and 3M™ Harvest RC Centrate Chromatographic Clarifier - a centrate clarification solution. This high-capacity, synthetic, single-use clarification platform offers several benefits:
Predictable scalability
Comparable high quality fluid across the platform
Enhanced product recovery >95%
Integrability into existing Solventum process hardware
Improved speed to market by streamlining clarification process development
Superior contaminant removal to <500 ppb DNA
One clarification platform.
A variety of benefits
A robust solution providing comparable effluent quality across both direct and centrate clarification processes.
Clarify centrate like never before
3M™ Harvest RC Centrate Chromatographic Clarifier is a range of high-capacity, single-use synthetic chromatographic clarification devices engineered to clarify centrate. Leveraging advanced material science technology, it provides a scalable solution that allows you to remove more contaminants earlier in the process, so you can benefit from downstream efficiencies later. This next-generation solution yields high-quality effluent while improving process economics for cost savings.
Superior contaminant removal for superior fluid quality, including DNA reduction to <500 ppb
Scalable and consistent performance from lab to manufacturing scale devices
Improved process economics to reduce cost
Platform scalability during process development and manufacturing
The 3M Harvest RC Chromatographic Clarifier platform capsule devices provide linear scalability that enables process scale-up, scale-out, and technology transfer from discovery to manufacturing. This can accelerate process development and simplify manufacturing strategies to improve process economics.
Scalability of 3M™ Harvest RC
Chromatographic Clarifier
Scalability of 3M™ Harvest RC Centrate
Chromatographic Clarifier
Predictable high fidelity clarification across process scales
The solutions in the 3M™ Harvest RC Chromatographic Clarifier platform provide comparable soluble and insoluble impurity reduction in terms of particle size and DNA clearance. This can simplify downstream process development and technology transfer across internal and external manufacturing footprints.
Quality of clarified fluid
DNA concentration
Quality of clarified fluid
average weighted particle size
What technology is right for your process?
3M™ Harvest RC
Chromatographic Clarifier
Direct clarification
Technology Platform
Quaternary amine (Q) functionalized polypropylene nonwoven
0.2 μm polyether sulfone (PES) membrane
Mechanism
AEX
Materials
Synthetic
Feed stream
Direct harvest
Scalability
Linear scalability from lab to multi-capsule commercial
production
Applications
Direct harvest in a single stage
Replacement of primary, secondary and guard filters
Features
High mAb product recovery (Capsules: >95%,
Conical Tube and Well Plate >90%)
Consistent cell loading capacity
Turbidity reduction (<15 NTU)
DNA reduction (<500 ppb)
Cell shear minimization
0.1 & 0.2 μm sterile filter protection
View more product details
3M™ Harvest RC Chromatographic Clarifier
3M™ Harvest RC Centrate
Chromatographic Clarifier
Centrate clarification
Technology Platform
Quaternary amine (Q) functionalized polypropylene nonwoven
Quaternary amine (Q) functionalized highly asymmetric 0.2 μm polyamide membrane
Mechanism
AEX
Materials
Synthetic
Feed stream
Centrate
Scalability
Linear scalability from lab to multi-capsule commercial
production
Applications
Centrate clarification
Features
High mAb product recovery (>95%)
Turbidity reduction (<15 NTU)
DNA reduction (<500 ppb)
Cell shear related submicron impurity removal
0.1 & 0.2 μm sterile filter protection
Frequently asked questions
Fiber chromatography is one of the chromatography methods which utilize fibrous matrix as chromatographic media. Due to larger porous structure of fibrous media, fiber chromatography can process significantly larger biological targets, such as cells, micelles, virus and chromatic DNA, which are too large for traditional chromatographic media like chromatographic beads and chromatographic membrane. Also, binding is predominantly convection-driven, enabling a fast processing rate.
3M™ Harvest RC Chromatographic Clarifier and 3M™ Harvest RC Centrate Chromatographic Clarifier are single stage single-use chromatographic clarification solutions. Both solutions provide efficient clarification of modern cell cultures with high product yield and high-quality effluent. However, the fiber chromatography media construction and formulation of these solutions differs due to their intended applications in mAb production with CHO expression systems. For its use in direct clarification applications, 3M™ Harvest RC Chromatographic Clarifier utilizes a more open fiber chromatography media to effectively capture cell mass. In contrast, 3M™ Harvest RC Centrate Chromatographic Clarifier was designed with a tighter fiber chromatography media to effectively capture cell shear related soluble impurities in the submicron size range that are typically present in abundance in centrate feed streams.
The 3M™ Harvest RC Chromatographic Clarifier platform consists of two solutions: 3M™ Harvest RC Chromatographic Clarifier for direct clarification of raw cell culture fluid and 3M™ Harvest RC Centrate Chromatographic Clarifier for centrate clarification. Together, these two next generation clarification solutions create a modern clarification platform that can be seamlessly implemented in current infrastructures and allow facility utilization. Both solutions provide high fidelity separation with comparable effluent quality to streamline process development, de-risk technology transfers, and improve speed to market.
Our Solventum experts will work bench-to-bench with you to uncover the right solution to fit your process needs. From R&D through development, our team of experts can help you throughout the process. Please CONTACT US for support.
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