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AppliFlex ST GMP
Single-use bioreactor for Cell & Gene Therapy and mRNA applications
- Seamless process transition from research to clinical production (both scale up and scale out)
- Designed to meet the requirements for clinical production, such as material requirements, traceability, particle requirements and much more
- Builds on the proven customization ability of the AppliFlex ST for research and development purposes
The AppliFlex ST GMP is available in 500 mL and 3 L and can be customized to your requirements.
Turnkey package
Leveraging our expertise, we can provide a turnkey lab-scale cGMP manufacturing platform to get you started right away. This package consists of the single-use AppliFlex ST GMP bioreactor, a control tower, software solutions and services like installation, verification and training.
Bring this single-use bioreactor straight to your cleanroom through AR
Are you interested in the single-use bioreactor, and would you like to get a virtual sample right now? Try these bioreactors in Augmented Reality*.
Scan the QR code on your desktop with your mobile device or click on the link directly on the mobile device and discover how the AppliFlex ST GMP would be on your bench.
*View this page on an Augmented Reality (AR) compatible device. Augmented Reality (AR) adds digital elements to the camera of your smartphone, creating the illusion that holographic content is a part of a physical world around you.
AppliFlex ST GMP 500 mL
Discover how this 500 mL single-use bioreactor will look in your cleanroom.
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*Disclaimer
Purpose/intended use: Getinge’s GMP compliant systems are intended to be used in GMP compliant production and research environments. The system is not intended to be used as a medical device.
Easy scale up and scale out
Following the strictest cGMP standards, the AppliFlex ST GMP reduces the challenges of process transfer to clinical production. The AppliFlex ST GMP leverages your development and validation work into a GMP design and production workflow for 500 mL and 3 L bioreactor systems.
Save time and costs by skipping the process transfer step moving to clinical production, and thereby reduce your time-to-market.
Full customizable design
3D printing technology allows for easy optimization of the bioreactor to match your process and application. The headplate can be configured to your unique needs from special ports, sampling lines, connectors, and spargers to addition bottles.
The unique design and verification of the AppliFlex ST GMP allows you to keep this flexibility while being compliant with cGMP standards. Bring your design to life with a custom AppliFlex ST GMP.
No cross-contamination
The AppliFlex ST GMP is a fully closed system. A wide range of aseptic connectors can be placed to reduce handling operations. Design has been optimized to reduce handling and make operation easy.
Using single-use sensors allows for a fully closed operation, ensuring sterility in your bioprocess.
Specifications
| Physical characteristics | 500 mL | 3 L |
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| Dimensions ( h x Ø ) | 236 mm x 75 mm | 340 mm x 130 mm | ||
| Weight | 0.2 kg (1 bioreactor) | 0.7 kg (1 bioreactor) | ||
| Bottom | Dished bottom | |||
| Total volume | 575 ml | 3 L | ||
| Working volume | 100 – 400 ml | 0.65 – 2.4L | ||
| H/D ratio total volume | 2.0 | |||
| H/D ratio working volume | 1.33 | |||
| Impeller type | Marine / Rushton / Anchor / None / Hydrofoil / Helical and more... | |||
| Impeller diameter | Customizable -xx- mm | 52 mm | ||
| Sparger type | Pipe with Ø2mm hole / Open pipe / Sparger stone / Jet sparger / Porous sparger and more... | |||
| Operating conditions | ||||
| Working temperature | 5 – 45 °C | |||
| Storage temperature | -80 – 45 °C | |||
| Design pressure | 0 – 0.5 barg | 0 – 0.1 barg | ||
| Mixing time | ~3 seconds | |||
| Sterilization | >25 kGy Gamma irradiation | |||
| Sensors options | Single-use sensors or traditional multi-use sensors | |||
*Disclaimer
Purpose/intended use: Getinge’s GMP compliant systems are intended to be used in GMP compliant production and research environments. The system is not intended to be used as a medical device.
The AppliFlex ST GMP is designed to produce clinical batches for:
- Cell therapy products
- Gene therapy products
- Viral vector components
- mRNA synthesis
- Biopharmaceutical cell culture
*Disclaimer
Purpose/intended use: Getinge’s GMP compliant systems are intended to be used in GMP compliant production and research environments. The system is not intended to be used as a medical device.