Ksep®: Scalable, Automated Cell Harvesting for GMP-Ready Therapies
Cell therapy manufacturing requires precision, scalability, and quality in order to achieve GMP compliance. However, manufacturers face critical challenges, like maintaining cell viability, reducing contamination risk, navigating complex workflows, and scaling efficiently—all under tight timelines.
The Ksep® system addresses these needs with an automated, single-use, closed system that enables gentle cell washing, concentration, and clarification via counterflow centrifugation. Designed for scalability and GMP compliance, Ksep® streamlines workflows from development to commercial scale, helping manufacturers develop efficient, reproducible cell therapy processes.
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.
Counterflow Centrifugation Portfolio
Ksep®: Scalable Cell Harvesting for Cell Therapy
The Ksep® portfolio is designed to facilitate consistent and gentle cell processing, suitable for harvesting various therapeutic cell types such as CAR-T cells, NK cells, MSCs, and iPSCs. It provides reliable performance for both early-phase trials and scaling for market needs.
| Attributes | Ksep® 50 | Ksep® 400 |
|---|---|---|
| Counterflow centrifugal force [g] | 2000 | 1000 |
| Cell throughput per cycle* | Up to 10 billion | Up to 80 billion |
| Minimum output volume range [mL] | 30 | 125 |
| Maximum peristaltic pump flow rate [L/hr] | 48 | 114 |
| Cell recovery [%] and cell viability [%] | >90% at <5% change | |
| Process volume (L) | 0.1-3.5 | 20-200 |
| View Product | View Product | |
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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).
Designed specifically for scalable cell processing and GMP-compliant workflows, the Ksep® system streamlines cell therapy manufacturing from early-stage development to full-scale production. By integrating Sartorius’ innovative technology, bioprocesses gain a reliable, contamination-free solution that accelerates development timelines, enhanced process reproducibility, and meets the demands of modern cell therapy production.
Choose Ksep® — the gold standard in scalable, automated cell harvesting — to power your cell therapy workflows with precision, efficiency, and confidence.
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 in 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., MSCs, iPSCs, NK cells, T cells, and CAR-T cells) for advanced therapy manufacturing.
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 process development 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 shear stress during harvest may lead to cellular damage and reduced viability.
Open processing steps and batch centrifugation increase the risk of contamination.
Inadequate washing procedures can result in poor product recovery and compromised quality.
Limited scalability restricts harvesting capacity in larger-volume production processes.
Ksep® Solutions
Ksep® counterflow centrifugation imparts minimal shear force, providing a gentle environment to preserve high cell quality.
Ksep® systems offer a closed, single-use solution for cell harvesting, effectively reducing contamination risk.
An integrated automated wash step removes media residues, improving product quality and process efficiency.
Ksep® provides a scalable platform from development through to large-scale commercial manufacturing.
Learn More About Counterflow Centrifugation
Related Assets
Scalable, Automated Cell Harvesting for Cell Therapy
Sartorius leads the way in scalable, automated cell harvesting solutions for advanced cell therapy manufacturing. Our Ksep® systems leverage state-of-the-art counterflow centrifugation technology within closed, single-use platforms to ensure high cell viability, yield, and full GMP compliance. Optimized for critical cell therapy workflows—including CAR-T, NK cells, MSCs, and iPSCs—Ksep® supports seamless scale-up from clinical trials to commercial production. With robust automation and contamination-free processing, Sartorius helps accelerate development timelines, enhance process reproducibility, and deliver reliable, high-quality cell therapies.
- Closed, Single-Use System: Minimizes contamination risk and simplifies validation
- Automated Counterflow Centrifugation: Gentle on cells, high yield, and viability
- Scalable Platform: From Process development to large-scale GMP manufacturing
- GMP-Ready – Supports compliance and reproducibility across batches
- Broad Compatibility – Optimized for diverse cell therapy workflows
Frequently Asked Questions
Counterflow centrifugation uses opposing forces of centrifugal force and fluid flow to gently capture and separate cells in a fluidized bed. Ksep® leverages this technology for continuous, automated cell harvesting that maintains high cell viability and yield.
Unlike traditional batch centrifuges, Ksep® uses continuous counterflow centrifugation in a closed, single-use system. This approach gently separates cells, preserving high viability and yield while reducing contamination risk. It supports scalable, GMP-compliant workflows with consistent, reproducible results—ideal for advanced cell therapy manufacturing.
Ksep® 50 is ideal for processing volumes from 100 mL up to 35 L, while Ksep® 400 supports larger-scale applications from 20 L to 200 L. Both systems are optimized for high recovery and viability across a wide range of cell therapy modalities, including CAR-T cells, NK cells, mesenchymal stem cells (MSCs), induced pluripotent stem cells (iPSCs), and other immune or stem cell types.
Both Ksep® 50 and Ksep® 400 can collect intact cells, aggregates, and particles 4 microns or larger, making them ideal for harvesting a wide range of cell therapy modalities. These include CAR-T, NK, MSCs, iPSCs and other immune or stem cell types. The systems also efficiently remove microcarriers by trapping them in the chamber using low g-force and high flow rates, while eluting the cells for gentle, high-yield washing, concentration, and harvesting.
Ksep® 50 and Ksep® 400 are designed to grow with your process—from early-stage clinical development to commercial-scale manufacturing. With seamless scalability between 100 mL and 200 L, the Ksep® platform enables consistent, high-viability harvesting across a wide range of cell types. Their closed, automated systems simplify tech transfer, reduce contamination risk, and accelerate your path to market.
