Cellana is a highly innovative, cGMP validated isolator designed for all specific cell and gene therapy processes. The modularity of the isolator allows flexible integration of different laboratory devices, such as refrigerated centrifuges, CO2 incubators, closed automated systems for cell processing, into a class A aseptic environment. As an isolator for Advanced Therapy Medicinal Products (ATMPs), Cellana assures aseptic working conditions with the highest sterility. The isolator is suitable for fast transfer of biological materials in cell culture flasks, cryo vials, apheresis bags, as well as for gene editing by viral transduction and electroporating.
SKANs process experts can guide you through the development of a high quality, robust and custom Cellana isolator design solution for autologous and allogeneic therapies.
Cellana isolator offers
- Aseptic isolator design with the highest sterility assurance
- Control and monitoring of the entire process technology
- Operator and patient safety with the highest hygiene standards
- cGMP design in compliance with the latest regulations
- Rapid market access
- Accelerated regulatory approval of custom isolators
- Production scale-up through duplication of identical machines
- Scale-up from clinical to commercial production
Highest standards for pharmaceuticals
- Cellanas technology complies with industry guidelines and regulations EU Annex 1, PIC/S Annex 2A and 2B, FDA, PIC/S, cGMPs.
- The isolator assures the highest aseptic standards for personalized medicine.
- Cellanas technological design prevents cross-contamination and provides an excellent cleaning solution.
- The isolator has advanced integrated solutions for manual, semi-automatic and automatic aseptic filling of various vials, and aseptic container closure systems.
The Cellana isolator family
The Cellana product family includes the Cellana M as a compact version with modular design and short delivery time (Fig.1) and the Cellana L, which offers high flexibility and versatility with interchangeable L-flange modules (Fig.2). In cooperation with Aseptic Technologies (AT) we offer the Cellana L1, a fill & finish product with state-of-the-art robot technology. Another product developed in cooperation with AT is the pure2 M1 . This is a complete fill & finish solution, neatly combining the AT-Closed Vial® Technology and a new generation of isolator by SKAN. Find out more here.
We are happy to support you in finding the right product for your process.
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Comparison table
| Quality and Value | Biosafety Cabinets | SKAN Cellana Isolators |
|---|---|---|
| Process operation handling | Open: easy but risky | Closed: easy, secure and compliant |
| Decontamination | Manual low bioburden cleaning | Rapid skanfog (R) integrated validated decontamination cycle |
| Sterility assurance level | 10E3 | 10E6 |
| Aseptic transfer | Open: high risk in Grade B background | Closed: low risk validated transfer |
| Cross-contamination | High risk with open process | Low risk with segregated process |
| Microbial-contamination | High risk with open process | Low risk with segregated process |
| Operator protection | Minimum protection | Full protection |
| Initial capital costs | Lower | Higher |
| Initial facility capital costs | Higher | Lower |
| Operational costs | Higher | Lower |
| Life cycle return on investments | Lower | Higher |
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