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Scalable Single-Use Centrifugation Systems

Sartorius patented Ksep® technology is the only current technology that provides significant advantages for users that want to either harvest cells as product or discard cells as by-product during manufacturing.

Through the balance of centrifugal and fluid flow forces, the Ksep® retains particles, such as cells or microcarriers, as a concentrated fluidized bed under a continuous flow of media or buffer. Ksep® systems are currently being used by top biopharmaceutical companies for diverse bioprocessing applications.

Our current offerings include two models with built-in scalability and are designed to handle low to very high cell densities. Our sterile disposable sets are manufactured using class VI materials.

Ksep® Benefits

  • Simple, robust, and scalable centrifugation process with low-shear
  • Closed system with class VI
  • Integrates and/or reduces processing steps and time
  • High secreted-product recoveries even with high cell densities

 

Our Applications

  • Harvest | Clarification
  • Cell Therapy
  • Vaccine Manufacturing
  • Blood Processing

 

Functional Principle

The Ksep® Advantages

Bioprocessing

  • Integrates and/or reduces processing steps and time
  • Improves recoveries of both solids and liquids
  • Provides option to selectively remove small particulate impurities, e.g. plastic generated, cell debris, extracellular viruses
  • Built-in scalability (4-6 fold) for development and manufacturing using the same system
  • Automated with option to run in complete manual mode
  • No hardware change for different applications
  • Handles low to high cell density cultures (>150 million cells/mL) equally well

cGMP Manufacturing

  • Closed system with single-use class VI product contact surfaces
  • Simple, robust, and scalable
  • One software for all systems
  • Clog-free and continuous operation

Advanced Cell Handling

  • Imparts low shear on cells and keeps the cells intact
  • Maintains a healthy environment to sustain cell viability
  • Complete supernatant product recovery from slurry without dilution
  • Reduces intracellular protein contamination for harvest applications by keeping the cells intact

 

Our Products

We offer two systems for development and manufacturing. Each system has built-in scalability and is capable of running multiple applications. Both systems are fully-automated (with the option to run manually), robust, simple, and scalable. The system can be operated under sterile conditions and all consumables are delivered pre-sterilized.

All product contact surfaces are composed of Class VI materials. We also provide support for customization and IQ/OQ as per your requirements.

Functional

Ordering Information

Ksep®400

Ksep®6000S

Max g-force

1000 g 2000 g

Max flow rate

114 L/hr 720 L/hr

Volume

400 mL (4x100mL) 6000 mL (6x1000mL)

Cell capacity per cycle

1-80 Billion cells 10-1200 Billion

Processing volumes

0.05-500L 0.5-6000L
Physical

Ordering Information

Ksep®400

Ksep®6000S

Height

140 cm 179 cm

Length

107.5 cm 225 cm

Width

72 cm 106 cm

Weight

350 kg 2141 kg
Process Connections

Ordering Information

kSep400

kSep6000S

All

3/8″ x 1/4″ C-Flex 5/8″ x 3/8″ C-Flex

Utility Requirements

Ordering Information

Ksep®400

Ksep®6000S

Voltage

208-240V 1Ph 208-240V 3Ph (US) / 400V 3Ph (EU)

Current

20 A 60 A

Process air

N/A 60 psi – 1/2″ NPT

Connection

NEMA L6-20 Customer supplied

Chilled water (optional)

1/2″ NPT 3/4″ NPT

Our Applications

We are continually working with clients to develop a wide range of additional applications including perfusion and microcarrier separation.

Harvest Clarification

Ksep® systems are the first single-use centrifugation systems that are completely closed. These systems are fully-automated and designed to recover >97% of product by efficient product displacement from slurry. In addition, low-shear process ensures reduced downstream contaminiation (due to cellular debris or proteolytic enzymes) and high product quality. Our systems have successfully been implemented for recombinant protein (e.g. mAb) manufacturing using CHO cell culture based processes.

Concentrate-Wash-Harvest

Ksep® centrifuges offer the benefit of concentrating cells, while maintaining high recovery and viability. Additionally, these systems can easily be programmed to remove cell debris, dead cells, and light particulate impurities (e.g. plastic particles from single-use plastic products), while significantly reducing any aggregation of cells. Ksep® systems are truly closed systems as they do not contain any rotary seals. Our systems do not contain any filters or membranes so that they can operate without clogging or exerting shear. These features are critical for cell therapy manufacturing.

Once captured and concentrated, the cells can be efficiently washed, manipulated, and harvested. Due to built-in plug wash option, Ksep® systems can wash cells and remove contaminants below detection levels in less than 5 minutes with a small amount of media or buffer. This technology is a breakthrough for applications requiring maintenance of cellular integrity during processing. This automated process sequence is currently being used for cell therapy manufacturing, cell banking, vaccine, and large-scale blood realted manufacturing processes.

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