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Isolators for Cell and Gene therapy - Solutions for Advanced Therapy Medicinal Products (ATMPs)

 

Your needs:

  • Aseptic controlled isolator to process autologous and allogeneic therapeutics for pre-clinical and human clinical use
  • Fast transfers of biological materials in various containers (cell culture flasks, vials, cryo vials, bags, etc.)
  • Gene manipulation by viral transduction
  • Aseptic working conditions with highest sterility assurance
  • Operator and patient safety
  • Acceptance from cGMP regulatory authorities (US FDA, EU EMA and other global agencies)

 

Our solution:

Utilize a flexible and modular platform with proven isolator solutions that can be customized to your ATMP process. Work with SKAN experts who have experience in wideranging applications to:

 

Features:

  • Proven solutions compliant with regulations like EU Annex 1, PIC/S Annex 2A and 2B, FDA, PIC/S and other global cGMPs
  • Highest aseptic levels will be achieved for cell processing
  • Cleaning solutions and cross contamination prevention
  • Advanced integrated solutions for manual, semiautomated and automatic aseptic filling of various vials and other aseptic container-closure systems

 

Protect your...

  • product from contamination
  • process from direct human bioburden (the leading source of aseptic process contamination)
  • personnel, operators and scientists from biohazards, potent or toxic compounds

 

Control and monitor your…

  • environment (fully compliant, Grade A aseptic manufacturing area) with integrated particle counters and active viable air samplers
  • process with a PC-based HMI, 21CFRPart11 compliant data handling and an advanced SCADA (Supervisory control and Data Acquisition)

 

Integrate your process equipment, such as…

  • advanced and efficient H2O2 integrated decontamination process with rapid aeration
  • incubators (RH, temperature, CO2)
  • centrifuges
  • tabletop lab equipment
  • single use disposables

 

Wide range of cell-related processes:

Ultra-fast material transfer with SKANFOG® flash decontamination solutions

  • Cell vials
  • Cell culture flasks
  • Leukapheresis bags

Upstream procedures

  • Cell thawing
  • Cell isolation
  • Cell seeding
  • Cell culture (centrifugation and incubation)
  • Gene editing
  • Cell reprogramming and differentiation

Cell expansion procedures

  • Cell expansion (bioreactors, T-flasks, shaker flasks,multi-layer adherent systems)

Downstream procedures

  • Cell purification (cell purifier/separator)
  • Cell filtration
  • Cell concentration (cell bioprocessor)

Aseptic filling procedures

  • Crystal® L1 Robot Line – a specially designed robotic solution for safer fill & finish of cell and gene therapies in AT-Closed Vials®
  • Wide range of small-scale filling machines for cell vials, cell bags and AT-Closed Vials®
  • VarioSys® filling solutions for vials, syringes with bulk and nested RTU (ready-to-use) formats

 

Consultancy – Excellence by Design

The ATMP and biological experts at SKAN can support you with the design of your process to achieve and guarantee excellence in process flow, ergonomics, automation, GMP compliance, process and operator safety. Just contact us.

Learn more in our brochure:

pdfDownload ATMP brochure

 

 

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