Ksep System
Powerful and Scalable Single-Use Centrifugation with Ksep® Systems
Sartorius Ksep® systems provide powerful single-use bioprocessing solutions in the fields of recombinant therapeutics, cell therapy, vaccine production, and blood processing. Depending on process requirements, Ksep fully automated systems are optimized to recover either the supernatant or solids such as cells and particles. Ksep® systems solve traditional centrifugation and filtration-based challenges by processing very high cell densities while delivering high recovery rates and product quality.
The patented Ksep® system technology is the only available technology that provides significant advantages for users who want to collect cells as the product or remove cells as a by-product during production.
Through the balance of centrifugal force and liquid flow force, Ksep® maintains particles such as cells or microcarriers as a concentrated fluidized bed under a continuous flow of media or buffer. These device systems are single-bowl centrifuges that continue rotating during discharge. The system can be operated under sterile conditions, and all consumables are delivered pre-sterilized.
- Categories: Process-Scale Filtration | Cell Harvest Filtration |
Advantages of Ksep Centrifuge Systems
Smart Bioprocessing
Integration and/or reduction of process steps and process time.
Recovery of both solids and liquids.
Selective removal of impurities consisting of small particles.
Built-in scalability, 4- to 6-fold, for development and production with the same system.
Automation with the option to operate in fully manual mode.
No need for hardware changes for different applications.
Equally effective with low- to high-cell-density cultures, over 150 million cells/mL.
Advanced Cell Processing
Applies low mechanical force to cells and keeps them intact.
Provides a healthy environment to maintain cell viability.
Complete recovery of the supernatant product from the homogenate without dilution.
Reduces intracellular protein contamination in cell harvesting applications by keeping cells intact.
Current Good Manufacturing Practice, cGMP, Compliance
Closed system with a single-use Class VI product contact surface.
Simple, robust, and measurable.
One software platform compatible with all systems.
Continuous and uninterrupted processing.
Applications of Ksep Centrifuge Systems
The applications in which Sartorius Ksep® systems are used can be summarized as follows:
Cell harvesting
Clarification
Cell therapy
Vaccine production
Blood processing
Concentration, Washing, and Harvesting
Ksep® systems concentrate cells with high recovery while maintaining a high level of viability. In addition, Ksep® systems significantly reduce cell aggregation while removing cell debris and light particulate impurities. Ksep® systems contain no rotating seals or filters, providing a fully closed system with reduced clogging-related issues. These features are critical for cell therapy manufacturing.
After concentration, cells can be efficiently washed, manipulated, and harvested. Ksep® is a major breakthrough for applications that require cellular integrity to be maintained during processing. This automated sequence is currently used in cell therapy manufacturing, perfusion, cell banking, and vaccine production processes. It is the only perfusion technology in which cell removal does not result in recovery loss.
Cell Harvest Clarification
Ksep® systems are the first single-use, fully closed centrifugation systems. These systems are fully automated and designed to recover more than 97% of the product through efficient product displacement from the homogenate. This process is independent of cell density. In addition, the low mechanical force process reduces downstream contamination caused by cellular debris or proteolytic enzymes and ensures high product quality.