Biologics

Accelerate mAbs and other biologics development with UniFuge®. Our low-shear centrifuge supports critical processes, including primary harvest clarification and cell retention, enabling process intensification and supporting high product yield and purity throughout development and manufacturing scale-up or scale-out.

How It Works

One cell processing platform for automated, high g-force, and low-shear biologics manufacturing

Enhance bioprocess efficiency with UniFuge’s tubular bowl technology. This low-shear platform automates key production processes in a closed, single-use system, reducing manual intervention and contamination risks. From early stage to GMP production, UniFuge streamlines workflows, supporting faster, more reliable biologics manufacturing.

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Harvest Clarification

Efficient removal of cell debris and impurities to reduce filtration requirements and prepare for downstream processing.

Cell Banking

Standard or high-density, high-volume cell banking with high yield and little to no viability loss.

Cell Retention

Semicontinuous media exchange in a closed system, retaining cells for further growth and production.

Inclusion-Body Separation and Wash

Efficient separation and washing of inclusion bodies, removing impurities and reducing filtration needs.

Cell Harvest and Wash

Automated cell capture and washing for product-containing cells minimizing labor in downstream processing.

Cell Lysate Clarification

Effective removal of cell lysate debris through high RCF or g-force, reducing or eliminating filtration required.

Key Benefits

Benefits of using CARR Biosystems for Biologics

Enhanced Product Recovery

Reduced filtration requirements and increased product recovery
Optimized G-force and low-shear processing preserve viability

Automated Harvest Clarification

Efficient and automated debris removal, reducing filtration needs
Lowered manual labor and increased harvest processing speed

Improved Bioprocess Efficiency

Reduced impurities from cell or vector damage due to low-shear
Improved efficiency with simpler downstream processing

Sterile Product Environment

Sterile, integral consumables reduce contamination risks
Aseptic connection options for closed processing

Data Highlights

Increased efficiency and productivity in biologics processing

Turbidity Reduction

UniFuge models achieve similar turbidity reduction to primary depth filtration, with over 90% reduction, supporting efficient clarification and increasing efficiency for downstream processes.

Cell Viability Post-Processing

The UniFuge system preserves cell viability across all scales, with percent viability consistently above 80%, maintaining the integrity of cells for high-yield biologics manufacturing.

Case Study

Low-shear centrifugation reduces turbidity and minimizes filtration needs

The Challenge

Biologics, such as vaccines and mAbs, are produced using high-density cell cultures, but traditional primary clarification methods struggle to handle the increased cell mass. Depth filters and disk-stack centrifuges cause shear forces that can damage cells and introduce impurities.

The Solution

The CARR team tested the UniFuge platform for turbidity reduction, cell viability, and lactate dehydrogenase (LDH) levels in CHO cell culture clarification. Flow rates of 100 mL/min, 400 mL/min, and 2000 mL/min were evaluated using the UniFuge Mini, Micro, and Pilot.

The Outcome

The UniFuge platform delivered:

Turbidity reduction: Reduced turbidity by over 90%, matching the performance of depth filtration.
Reduced secondary filtration: UniFuge processed broth enabled substantially higher secondary filter capacity in comparison to broth post-primary depth filtration, suggesting elimination of primary depth filters and substantial reduction in secondary depth filters.
Reduced Contaminants: UniFuge processed broth had lower measured LDH-levels, indicating reduced shear-induced damage and possible associated downstream contaminants.

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Endorsements

See what people are saying about Biologics

“The 20L/min flow rate is great for harvesting from 1,000-2,000 L+ bioreactors. Processing ~1,000 L/hr is very helpful for our operators. It would save a significant amount of time.”

mAb Bioproduction Expert

“The UniFuge line is easy to scale-up to the U2k or down to the UFMini.”

mAbs Bioproduction Expert

Application Resources

Harvest of HEK Cells in Extracellular Expression Systems and for n-1 Seed Train Intensification

See how the UFMini clarifies HEK cells with high recovery and minimal impact on cell viability for seed train intensification.

Whitepaper

Addressing the Complexities and Challenges in Lentivirus Harvest Clarification

Read how single-use centrifugation improves recovery, reduces the need for filtration, and boosts operational efficiency in gene therapy production.

Article

Single-Use Centrifuges Are Transforming Biopharmaceutical Development and Manufacturing

Learn how UniFuge can boost productivity, reduce costs, and provide a scalable solution from bench to manufacturing.

Whitepaper

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Centrifuges

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Frequently Asked Questions (FAQs) About Biologics

How can the UniFuge enhance my mAb or other biologics harvest clarification process?

The UniFuge system, with relative centrifugal force (R.C.F.) up to 4000 xg in its single-use format, efficiently removes cellular debris and particulates from cell culture fluids, allowing secreted proteins and biomolecules to flow through. By automating the harvest step, the UniFuge simplifies the process and reduces or even eliminates the need for complex, multi-stage depth filtration.

How does the UniFuge system compare to single-use depth filtration?

The UniFuge system comes pre-sterilized with aseptic connection options for closed-system processing at both small and large scales. Its centrifuge hardware and automation provide streamlined, automated operation. In contrast, most single-use depth filtration pods or cassettes require burdensome setup and sanitization with caustic buffers after installation. They also demand large pre- and post-processing buffer volumes and often result in messy disassembly.

By using the UniFuge for primary clarification, you can significantly reduce or even eliminate the need for depth filtration, along with the associated challenges.

What are the possible environmental impacts of using the UniFuge system for biologics harvest?

Many single-use bioprocesses that rely on depth filtration generate significant waste due to filter clogging. As more volume is processed, the need for buffers, caustics, and filtration materials increases. In contrast, a single UniFuge centrifuge can process from 10 to over 1000 liters without clogging or needing additional equipment.

Depth filters also require large amounts of buffers and caustics for preparation and decontamination. The UniFuge system comes pre-sterilized with aseptic connections and can be easily drained and disconnected after use, eliminating the need for these chemicals.

Additionally, a large portion of the materials in depth filter pods or cassettes are needed for structural purposes, which increases solid waste. UniFuge modules, however, are designed with durable stainless steel fixtures, allowing a 2 lb device to process up to 1000 liters of cell culture fluid with minimal waste.

Can I use the UniFuge for other aspects of biologics production beyond harvest clarification?

Yes, the UniFuge can be used across various stages of the bioprocess workflow, including cell banking, intermittent semicontinuous media exchange (similar to perfusion), cell washing, and buffer exchanges.