Scalable Single-Use Centrifugation Systems
Scalable Single-Use Counterflow Centrifugation for Closed Cell Processing
Ksep® systems are automated, single-use solutions designed to minimize contamination risks by reducing the need for manual handling. Ksep offers scalable counterflow continuous processing for aseptic cell concentration, wash, and harvest in cell therapy manufacturing, supporting high recoveries. By harmonizing a balance between centrifugal and fluid flow forces, it imparts very low shear on cells, ensuring high viability and yield. The automated cell wash feature enhances harvest quality in cell processing applications. The Ksep® system is adaptable from process development (0.1 L) to commercial manufacturing (2,000 L), providing seamless scalability.
Choose the Right System
Find the Right System
Ksep® is a single-use platform designed for closed processing. Ksep® systems offer dual functionality, catering to both cell harvesting (for advanced therapies) and cell removal (clarification).
Our Ksep® portfolio seamlessly scales from early development and research to cGMP production, accommodating bioreactors of up to 2,000 L. Its gentle processing capabilities enable cell recoveries of > 90% without compromising viability across the broad range of cell densities.
Ksep® 50 | Ksep® 400 | Ksep® 6000S | |
|---|---|---|---|
| Process Volumes | 0.1 L – 20 L | 10 L - 200 L | 100 L – 2000 L |
| Cell Capacity per Cycle | Up to 10 Billion Cells | Up to 80 Billion Cells | Up to 1,200 Billion Cells |
| Volume | 50mL (2x25mL) | 400 mL (4x100mL) | 6000 mL (6x1000mL) |
| Max Flow Rate | 48 L/hr | 114 L/hr | 720 L/hr |
| Max g-Force | 2000 g | 1000 g | 2000 g |
Ksep® 50
The Ksep® 50 is a low-shear counterflow single-use centrifuge that delivers exceptional viability and recovery within an automated closed system.
- Automates cell concentration, wash, and harvest processes, specifically benefiting allogeneic cell therapies.
- Suitable for process development (0.1 L) to pilot-scale (20 L) commercial manufacturing.
- Reproducible and gentle processing maintains cell viability and achieves >90% cell recovery.
Ksep® 400
The Ksep® 400 is a closed, scalable counterflow centrifugation system that provides a compact single-use bioprocessing solution.
- Enables users to harvest cells as a product or discard them as a byproduct.
- Seamlessly scales from pilot- (10 L) to mid-scale (200 L) commercial operations.
- Highly efficient for optimizing cell or supernatant harvest processes and particularly suited for automated cell harvest.
Ksep® 6000S
The Ksep® 6000S is designed to continuously recover supernatant or solids while applying minimal shear on cells, resulting in unparalleled cell recovery and high throughput.
- Tailored for process-scale operations, it supports process volumes of up to 2000 L.
- Automated and highly efficient processes are ideal for high-intensity production scales.
- Handles low to very high cell density cultures with equal effectiveness, ensuring reliable performance across various applications.
Applications
Ksep® Applications
Patented Ksep® Systems technology is the only scalable technology that provides significant advantages for users who want to either harvest cells as a product (advanced therapy manufacturing) or discard cells as a byproduct (mAb manufacturing).
Harvest Clarification
Ksep® Systems are fully automated and designed to recover > 90% of the product during cell harvest and > 95% of the product during clarification applications by efficient product displacement. Low-shear processes ensure reduced downstream contamination due to cellular debris or proteolytic enzymes and high product quality. Ksep® Systems have successfully been implemented for recombinant protein (e.g., mAb) manufacturing using CHO cell culture-based processes.
Cell harvest | Advanced Therapy Manufacturing
Ksep® centrifuges offer the benefit of concentrating cells while maintaining high recovery and viability. These systems have a built-in wash function that can remove cell debris, dead cells, and light particulate impurities in less than five minutes. Sartorius systems can process various cell types (e.g., MSC, iPSC, NK cells, T-cells, CAR-T cells) for advanced therapy manufacturing.
Functional Principle of Counterflow Centrifugation
Counterflow Centrifugation | Increase Recovery and Product Quality
Ksep® centrifuges retain particles, such as cells or microcarriers, in a concentrated fluidized bed under a continuous flow of media or buffer. Through a harmonious combination of centrifugal force and fluid flow, the system minimizes shear forces on cells, addressing prevalent concerns associated with traditional centrifugation and filtration methods. This innovative approach accommodates a broad range of cell densities, from low to very high, while ensuring high recovery and product quality.
Designed For Cell Therapy Manufacturing
Ksep® Systems for Cell Therapy
Traditional centrifugation methods produce high shear forces that often damage cells during cell processing in advanced therapies. The Ksep® systems use advanced counterflow centrifugation, which reduces shear forces and the potential for cell lysis, resulting in superior viability and greater recovery.
It reduces the need for manual intervention and offers seamless scale-up from PD to commercial manufacturing, through an automated, single-use, closed, system, that protects cells and cell products from the risk of contamination, while maintaining high cell viability and quality.
Challenges in Cell Therapy Manufacturing
- Potential risk of shear stress occurring during the harvest process resulting in cellular damage and subsequent cell death.
- The risk of contamination of the cell product by open process steps and batch centrifugation.
- Inadequate washing procedures result in poor product recovery and quality.
- Limited scalability hinders harvesting in the production processes to accommodate larger volumes.
Ksep® Solutions
- Ksep® counterflow centrifugation imparts minimal shear force, ensuring a gentle environment for sustaining high cell quality.
- Ksep® systems offer a closed, and single-use option for cell harvesting, effectively mitigating the risk of contamination.
- Ksep® systems incorporate an automated wash step that effectively eliminates media residuals, thereby enhancing product quality and process efficiency.
- Ksep® offers scalable platform from development to large scale commercial manufacturing.
