Products
Cellana

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 bag, 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 Crystal® Cellana L1, a fill & finish product with state-of-the-art robot technology. Another product developed in cooperation with AT is the Crystal® Pure 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: www.aseptictech.com/products/pure-m1

We are happy to support you in finding the right product for your process.

  • Cellana – The guardian in your work environment
    • The product is protected from contamination by operating in a Grade A environment.
    • Working with Cellana eliminates the risks of direct human bioburden, which is considered the main source of contamination in aseptic processes.
    • The isolator protects personnel, operators, and scientists from biohazard and potent or toxic compounds.
  • Cellana – Puts you in control
    • The isolator offers a Grade A aseptic manufacturing area, which includes an active air sampler in addition to an integrated particle counter.
    • All data and controls are GAMP5 batch reporting compliant with 21 CFR Part 11.
    • Critical parameters and data with a user-friendly HMI.
  • Integrate your process equipment
    • skanfog® micro fogging technology: Advanced and efficient H2O2 integrated decontamination process with rapid aeration and safety monitoring.
    • SKANs nanox® catalyst: Integration of patented nanotechnology catalyst for complete H2O2 decomposition before air recirculation to the room.
    • Incubators (RH, temperature, CO2)
    • Centrifuges
    • Various devices for gene manipulation
    • Closed automated systems for cell processing: Cell separation, cell washing and cell concentration
    • Lab disposables
    • Various tabletop laboratory equipment
  • The wide range of cell and gene therapy related processes

    Ultrafast material transfer with skanfog® technology

    • Cell vials
    • Cell culture flasks
    • Leukapheresis bags

    Upstream processes

    • Cell thawing
    • Cell isolation
    • Cell seeding
    • Cell culture (centrifugation and incubation)
    • Gene editing
    • Cell reprogramming and differentiation
    • Cell expansion (bioreactors, T-flasks, shake flasks, adherent multilayer systems)

    Downstream processes

    • Cell purification
    • Cell filtration
    • Cell concentration

    Aseptic process

    • Crystal® Cellana L1 robotic filling for AT-Closed Vials®
    • VarioSys® flexible filling system

Get in touch with our sales team!

Comparison table

Quality and ValueBiosafety CabinetsSKAN Cellana Isolators
Process operation handlingOpen: easy but riskyClosed: easy, secure and compliant
DecontaminationManual low bioburden cleaningRapid skanfog (R) integrated validated decontamination cycle
Sterility assurance level10E310E6
Aseptic transferOpen: high risk in Grade B backgroundClosed: low risk validated transfer
Cross-contaminationHigh risk with open processLow risk with segregated process
Microbial-contaminationHigh risk with open processLow risk with segregated process
Operator protectionMinimum protectionFull protection
Initial capital costsLowerHigher
Initial facility capital costsHigherLower
Operational costsHigherLower
Life cycle return on investmentsLowerHigher


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