Manufacturing of cell therapy products is challenging because of the variability of starting materials and the complexity of cell culture conditions. The Quality-by-Design (QbD) approach that goes into this quality-oriented manufacturing process is crucial in that it exercises a quantitative assessment of the fluctuations during the manufacturing process and links these to the quality of the final product.
The ICP System comes installed with Process Analytical Technology (PAT) to monitor the culture condition in real-time so that the System can provide cell manufacturing that meets your quality allowance range at a reasonable cost.

※ Joint development with the Foundation for Biomedical Research and Innovation at Kobe and SAKARTA Ltd. in the UK

Features

  • This system can control the complex and diverse character of cell quality not only in the final stage, but during the manufacturing process. (QbD approach)
  • The QbD approach allows not only quality management, but continuous improvement of the manufacturing process.
  • This validated completely closed system guarantees an aseptic culture environment.
  • Automated system operation does not require skilled technical proficiency or special training. The system helps reduce power consumption as well as mitigating against human error thereby helping to reduce manufacturing costs.
  • This culture system uses multi-layered vessels, making it easier to scale up culture protocols carried out in petri dishes or flasks.
  • The various data gained through this CSV (Computerized System Validation)-compatible system are linked with higher-level management systems to help with consistent quality management from the introduction of raw materials to delivery of the final product.

System Configuration

Specifications

Cell types Adherent cells (iPS cells, MSC)
Function
(culture)
Seeding, medium exchange, passage, harvest
Function
(analysis)
Image observation, culture media analysis
Culture container Multi-layered container
Culture surface Max. 6,300cm2
Shape analysis CMOS camera
Culture media
analysis
Inline: lactic acid, glucose, pH
Offline: Biomarkers (2-aminoadipic acid, kynurenine)
Power consumption Approx. 5.9kw
Power supply AC240V 1Φ 50Hz
UPS Optional (MAX 3,000VA)
Ambient environment Temp: 18-25°C Humidity: 75% or less (no condensation)
Cleanliness: Grade C
Outer dimensions Width 2,750× depth 995× height 2,204mm (no protruding parts)
Weight Approx. 2,000kg
Air supply CO2,clean-dry air (both should be 0.3-0.5MPaG)

Disposable parts

  • Disposable closed-system culture kit
  • Culture vessels

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