SKAN AG

Cellana

Cellana is a highly innovative cGMP validated isolator developed for all specific cell and gene therapy processes. Thanks to the modular design of the isolator, flexible integration of various laboratory devices such as refrigerated centrifuges, CO 2 incubators, closed automated systems for cell processing in an aseptic environment of clean room class A is possible. As an isolator for the development of advanced therapy medicinal products, the Cellana isolator ensures aseptic working conditions with the highest level of sterility security. The isolator is suitable for rapid transfer of biological material into cell culture flasks, cryotubes or apheresis bags as well as gene editing using viral transduction and electroporation.

The process experts at SKAN can provide you with expert support throughout the development of a high-quality, robust and tailor-made Cellana isolator solution for autologous and allogeneic therapies.

The Cellana Isolator from SKAN offers

• Aseptic isolator design with maximum sterility assurance
• Control and monitoring of the entire process technology
• Operator and patient safety according to the highest hygiene standards
• Design according to cGMP in accordance with current regulations
• Fast market access
• Accelerated regulatory approval of custom isolators
• Scaling production by duplicating identical machines
• Scale-up from clinical to commercial production

Highest standards in aseptic isolator technology for pharmaceutical production

• The technology of the Cellana complies with the relevant industry guidelines and regulations such as EU Annex 1, PIC/S Annex 2A and 2B, FDA, PIC/S, cGMPs.
• The Cellana isolator guarantees the highest aseptic standards in the field of personalized medicine.
• Cellana's technology concept prevents cross-contamination and offers an excellent cleaning solution.
• The isolator has modern integrated solutions for manual, semi-automated and automatic aseptic filling of various ampoule formats and aseptic container closure systems.