Cellana Isolators Cell and Gene Therapy ATMPs

Key Steps to achieve Best Process Quality in Cell and Gene Therapy Advanced therapy medicinal products (ATMPs) are fast-growing fields in modern medicine. ATMPs comprise innovative and sophisticated medicines to treat a varietyo f human disorders and genetic diseases. It is critical to invest in manufacturing processes for these products to be compliant with cGMP regulations for the preparation and aseptic filling of sterile therapeutics for clinical and commercial use. Explore an isolator for ATMP processes “My primary concern is protecting my process. Isolators provide a much higher level of...

Adopt the best proven technology Integrate lab and process equipment into your ATMP solution Perform safe material transfers skanfog® automated decontamination Patented nanox® catalyst technology Everything you need to control and operate your ATMP process is here. Advanced process and lab equipment can be integrated directly into your Cellana isolator, creating a true process solution within a fully compliant manufacturing platform. Aseptic transfer of supplies, equipment, buffers, media and most importantly, living cells, is a key function for your aseptic processing isolator. Choose the right...

Cellana-M Cellana-L The Cellana Isolator family represents SKAN’s 50+ years of experience in aseptic processing isolators. cGMP knowledge and process expertise are combined to safely provide patients with your Cell & Gene Therapy products. Key Features —> Modular w/ Flex chamber —> Integrated design —» Short delivery Key Features —> High flexibility —> Interchangeable modules —> Scalability and versatility Main Features and Benefits FDA ISO 5/EU Grade A aseptic environment with unidirectional airflow Integrated automated H2O2 decontamination validated with expert process guarantee and SKANalytix...

Apply the right solutions to your process Example: Mesenchymal Stem Cell preparation From cell thawing to cell harvesting and final downstream steps in Cellana-M Cell thawing Cell centrifugation Cell growth in CO2 incubator Cell seeding Final Aseptic Filling Cell pellet resuspension Cell harvesting and filling Cell growth in CO2 incubator Cell centrifugation Cell harvesting Cell filtration Cell pellet resuspension

Example: CAR T-cell therapy production Step-by-step from aseptic leukapheresis bag transfer, gene editing and CAR T-cell separation to final cell formulation in a high-throughput Cellana-L isolator system. Leukapheresis Leukapheresis Leukapheresis T-cell modification T-cell Expansion Cell collection Cell collection T-cell activation T-cell activation T-cell modification T-cell Expansion CAR-expressing CAR-expressingFinal Cell Final CellInfusion (viral vectors, (viral electroporation) vectors, electroporation) and separation and separation T-cell isolation T-cell isolation FormulationFormulation...

5 ImplementFlexible Aseptic Filling SKAN provides a wide range of fully-integrated isolator-based aseptic filling solutions. Cellana is your one-stop solution for manual to highly automated filling, including robotic systems.

Validate your process with Expert Support The scientific method is the only approach for successful qualification of cGMP processes. Quality must be implemented in the design phase (QbD). SKAN’s compliant regulatory strategy maintains your product quality at the highest level. We collaborate with our partners and share our experience to define the right isolator for your specific needs. Utilise smart digitalisation solutions SKAN integrates digital solutions for your process control and automation needs

SKAN Stein AG Rüchligstrasse 296 4332 Stein, Switzerland +41 62 873 18 41, [email protected] SKAN Deutschland GmbH Nickrischer Straße 2 02827 Görlitz/Hagenwerder, Germany +49 358 223 789 0, [email protected] SKAN US, Inc. 7409 ACC Blvd., Suite 200 Raleigh, NC 27617, USA +1 919 354 6380, [email protected] SKAN Japan 5194-61 Katsuren-Haebaru Uruma-shi Okinawa 沖縄県 904-2311, Japan 日本 +81 98 934 9922, [email protected] Aseptic Technologies Rue Camille Hubert 7-9 5032 Gembloux /Les Isnes, Belgium +32 81 409 410, [email protected]