Enhanced Cell Viability
- Low-shear separation to preserve cell health
- Efficient cell washing and buffer exchange to remove spent media or reagents
Cell Therapies
Streamline your cell therapy development and manufacturing with a scalable, low-shear platform designed to maintain cell viability. UniFuge® offers capabilities beyond cell harvesting, supporting gene editing, cryopreservation, and bioreactor expansion for consistent results from research through large-scale production.
How It Works
One cell processing platform for the full cell therapy development cycle
The UniFuge platform uses tubular bowl technology for gentle cell processing, ideal for preserving cell viability. Automating key processes like cell separation and media exchange, UniFuge maximizes workflow efficiency for cell therapy applications. Its single-use, closed design minimizes contamination risks while streamlining critical unit operations to ensure reliable results.
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Gene EditingGentle separation concentrates cells and exchanges media, preserving cell integrity before gene editing. | Cell BankingGentle separation concentrates cells and exchanges media, preserving cell integrity before gene editing. | Seed TrainScalable processing efficiently separates and concentrates cells, preparing them for transfer to larger bioreactors for further expansion. |
Expansion & DifferentiationMedia exchange and optional washing remove residual media while maintaining cell health for continued growth or differentiation. | Cell HarvestLow-shear separation gently concentrates cells, minimizing damage with optional washing to enhance purity. | Formulation, Fill, CryoCells are concentrated and media exchanged with formulation buffers, preparing them for cryopreservation with minimal loss and high viability. |
Key Benefits
Benefits of using CARR Biosystems for Cell Therapies
Increased Cell Recovery
- Tunable parameters for optimized recovery across cell lines
- No cell loss during centrifuge acceleration
- Efficient concentration for downstream processing
Fast Cell Processing
- Minimized dwell time and reduced time between steps preserve cell viability and health
- Adaptable volumes and concentrations based on processing needs
Seamless Scalability
- Seamless scalability from development to manufacturing
- Automated processes with quick setup in under 15 minutes
- 21 CFR Part 11 compliant
Data Highlights
High viability across cell types: TIL, NK, and stem cells
Cell Viability and Recovery
UniFuge delivers high cell viability and recovery, achieving over 98% recovery for iPSC, TIL, stem, and NK cells with over 99% viability. For MAPC cells, it ensures over 95% recovery and 99% viability.
Cell Washing Efficiency
UniFuge demonstrates >99% washing efficiency after just two washes, effectively removing residual media and additives.
Case Study
Low-shear processing achieves over 95% recovery across multiple cell types
The Challenge
During cell therapy manufacturing, maintaining cell viability and recovery during harvesting is critical, but many available technologies fall short. Some provide high recovery but damage cells, while others preserve viability but underperform in recovery.
The Solution
CARR Biosystems partnered with a customer to test the UniFuge Pilot and UniFuge Mini for cell harvesting in various cell types, including stem cells, NK cells, and MAPCs. Different g-forces (400-1200 x g) and flow rates (100-1,600 mL/min) were evaluated to optimize recovery efficiency and minimize viability reduction across multiple operating conditions.
The Outcome
The UniFuge platform delivered:
- Minimal viability loss: Less than 1.6% reduction in viability across all cell types.
- High recovery efficiency: Greater than 95% recovery for all tested cell types.
- Optimized scalability: Efficiently processed at flow rates ranging from 100 to 1,600 mL/min with varying g-forces.
Endorsements
See what people are saying about Cell Therapies
"This one is perfect. This would reduce our harvest time significantly. I think it fits well into the needs for a Phase III trial."
Cell Therapy Bioproduction Expert
“The UniFuge was fairly simple to use and scaled nicely from the UFMini.”
Cell Therapies Bioproduction Expert
"[The UniFuge line] is scalable, easier to operate, and my process yield is better than using depth filters."
Protein Separation Bioproduction Expert, CHO
“The UniFuge line is simpler and required less calibration than other solutions we have tried.”
Protein Separation Bioproduction Expert, CHO
Centrifuges
Scale up or down with UniFuge
Frequently Asked Questions (FAQs) About Cell Therapies
What stage of cell therapy development can UniFuge support?
The UniFuge is scalable from small (250mL) to large volumes (over 2000L), supporting various stages of cell therapy development.
How does the UniFuge system’s single-use design support sterility and contamination control?
UniFuge’s single-use design, manufactured in an ISO 13485 facility, enhances sterility by reducing the risk of cross-contamination. Components are gamma-irradiated, endotoxin-free, and free of animal-derived materials, making the system ideal for clinical manufacturing while ensuring a sterile and controlled environment. Additionally, UniFuge is 21 CFR Part 11 compliant, providing audit trails and features including SCADA integration and cGMP documentation.
How are centrifuges used in cell therapies?
Centrifuges are essential in cell therapy manufacturing for separating, concentrating, and washing cells. They are used to harvest cells from bioreactors, reduce contaminants, and prepare cells for further processing like gene editing or cryopreservation. Gentle, low-shear centrifugation helps preserve cell viability and recovery, which are critical for maintaining the therapeutic potential of the cells. Centrifuges also streamline steps like media exchange, helping maintain optimal conditions throughout the cell therapy workflow from research to large-scale production.
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