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CelCradle X® Closed Automated Single-Use Bioreactor

The Next Cradle Generation for Adherent Culture
Adherent culture bioreactor platforms have different advantages for different applications such as for vaccine production and cell therapy. CelCradle X® is designed as single-use, closed, and automated bioreactor based on the Tide Motion platform. It is manufactured in an ISO 13485 Esco factory and complies with cGMP requirements of 21 CFR part 11. Whether you are planning to simplify your cell therapy manufacturing, CCX adoption in the early phase of culture production can help streamline your bioprocessing and reduce challenges faced when manufacturing scale-up.
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CelCradle X<sup>®</sup>

Tide Motion in CelCradle X®

The cyclic upward and downward motion, or Tide Motion in CelCradle X provides alternate exposure of nutrition and aeration to the cells attached packed bed. The packed bed varies from BioNOC™ II, BioMESH® macroporous carriers or the user’s own.


Features

  • Perfectly suited for autologous cell therapy
  • Combination Technology: Multiple-use or Single-use Components
  • Complete standalone bioreactor running on Siemens HMI/PLC with single-use bottles, pH, and DO sensors
  • Equipment integration with Esco Laminar Airflow Cabinet, Biosafety Cabinet, or Cell Processing Isolator
  • Equipped with automated seeding and control of pH/DO and glucose concentration (optional)
  • Equipped with a single-use automated harvesting system
  • Equipped with autoclavable pH/DO sensors for process development and switchable in situ for single-use pH/DO sensors
  • Optional H2O2 bio-decontamination system integration
  • Process Modes:
    • Batch
    • Fed-Batch
    • Perfusion

Applications

  • Vaccine Production
  • Monoclonal Antibodies or Recombinant Proteins for therapeutics/in vitro/in vivo diagnostics
  • Drug Discovery
  • Conditioned media production for cosmeceuticals
  • Adherent cell master cell bank (MCB) or working cell bank (WCB) generation
  • Intracellular, Secreted Viral Vector or Virus Process Development
  • Proteome Research
  • PK/PD Testing
  • Virus MVB production

CelCradle X® External View

CelCradle X® Internal View

Highlights

Combination Technology

Automated single-use bioreactor for autologous cell therapy has becoming a modality in the industry. Aside from its advantages for its straightforward approach in culture, it provides a more robust approach to eliminate or reduce obstacles faced in manufacturing. CelCradle X® (CCX) is a combination of both single-use or multiple use mixer for achieving a safe and effective adherent culture production.

Two models are avaialable for the CCX:

• SA-SUGH

The CCX-SA-SUGH is a semi-automated bioreactor model that uses a single-use CCX bottle and a glass or single-use mixer. The mixer component varies from the process mode needed in the culture run. For processes that require perfusion mode, a 0.5L single-use vessel shall be used to accommodate the embedded feeding and harvesting rate. Sensors can either be autoclavable or inline depending on the user’s requirement.

The CCX-SA-SUGH that opt to do a batch process, the 2 L glass vessel shall be used. Base parameters such as maintaining glucose concentration as well as pH will be controlled during the culture run.

• SA-SUB

The CCX-SA-SUB model is a semi-automated bioreactor that only uses single-use components from its main vessel (where the packed bed is) to mixer (for culture medium homogeneity). The pH/DO sensors are also single-use thus offering a complete single-use solution for the adherent culture process. For perfusion processes required in the run, a 0.5 L single-use vessel equipped with in line sensors shall be used. The main vessel is packed with a 0.1 L BioNOC™ II or BioMESH® for cell adherence in 3D.

Batch process includes a single-use main vessel packed with 0.1 L BioNOC™ II or BioMESH® with a 2 L single-use mixer. This model is equipped with separate single-use bags for glucose maintenance and base solutions.

Process Scalability

The CelCradle X single-use bioreactor helps to provide solutions faced in adherent culture processes especially in its expansion, viral transfection/transductions, and more. The production of stem cells for example in a 0.1 L packed bed offers up to 6,400 cm2 surface area for 3D cell growth. This in vivo-like nature of macroporous carriers maintains the cell’s characteristics and stable cell culture environment either in hypoxic or normoxic conditions.

Manual processes are reduced in this format as CCX can linearly scale-up to TideXcell® bioreactor especially when switching to allogeneic cell therapy. The CCX can automatically harvest cells using the CCX®-SAH with more than 90% efficiency. It also reduced the need for GMP-grade cleanrooms and consumable costs.

Frequently Asked Questions
The CelCradle X is equipped with its own incubator where the user can control the CO2 concentration. For hypoxic conditions, the bottom holding time is increased for cells attached to the carriers to have longer exposure time to air.
The CCX automated bioreactor is available in models where the client’s own carriers can be used. However, these carriers should be macroporous for optimized 3D culture. Microcarriers are optimized in different agitation principle which is mostly in stirred format using BioXcell.
The CelCradle X® is equipped with a 21 CFR Part 11 Compliant software that is designed in a straightforward manner to accompany the user in their culture run to start in the shortest possible time.
Depending on the type of cells being cultured as well as the application, parameter set-up varies. The Tide Motion parameters have to be known as well as calculating the feeding/harvesting rate for perfusion process modes. The CCX almost works the same with TXL, therefore, offering ease of scale-up for manufacturing.
Cleaning your glass vessel requires detergent, and in most cases, water is sufficient to remove unwanted dirt and stains. Depending on the product cultured in the system, certain decontamination steps should be done to avoid future culture problems (like contamination).
Adherent cell lines such as VERO, HEK293, Human Mesenchymal Stromal Cells, CHO, and more can be cultured in CCX. The system can ONLY culture adherent cell lines through attaching through the provided carriers or the user’s own.
The scalability feature of CCX enables flexible and reliable cultivation from bench scale to manufacturing. Rather than scaling out, users can scale-up to a larger volume maintaining accurate parameter controls for optimized culture conditions. Its combination technology feature also offers an advantage for those who plan to scale a flask-based process.
This automated bioreactor can control pH/DO levels as well as glucose concentration. The Tide Motion parameters are also set for cell nutrition-aeration exchange.
Yes, the system is GMP compliant. The software features aid in the Part 11 of the current good manufacturing practices.