{"id":52691,"date":"2025-06-23T14:03:00","date_gmt":"2025-06-23T12:03:00","guid":{"rendered":"https:\/\/skan.clients.ideeal.ch\/produkte\/%taxonomy%\/cellana-xl1-2"},"modified":"2026-05-13T22:53:56","modified_gmt":"2026-05-13T20:53:56","slug":"cellana-xl1-2","status":"publish","type":"produkte","link":"https:\/\/skan.com\/en\/products\/pharma\/fill-finish\/cellana-xl1","title":{"rendered":"Cellana XL1"},"content":{"rendered":"
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Cellana XL1 at a glance<\/h5>\r\n

100 % IPC for maximum safety for ATMP filling<\/h2>\r\n <\/header>\r\n
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    Filling accuracy<\/h3>\r\n

    100% IPC of weight for each vial, supported by automated calibration for consistent dosing accuracy<\/p>\r\n <\/div>\r\n <\/li>\r\n

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    Sterility assurance<\/h3>\r\n

    Fully automated robotic filling process, AT-Closed Vial\u00ae technology and integrated skanfog H\u2082O\u2082 decontamination<\/p>\r\n <\/div>\r\n <\/li>\r\n

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    Reduced contamination risk<\/h3>\r\n

    Bulk product containers remain outside the isolator and connect via the AT-Port aseptic liquid transfer system<\/p>\r\n <\/div>\r\n <\/li>\r\n

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    Regulatory compliance<\/h3>\r\n

    Fully aligned with GMP and 21 CFR Part 11 requirements with comprehensive validation package<\/p>\r\n <\/div>\r\n <\/li>\r\n

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    Single-use pathways<\/h3>\r\n

    Disposable filling kits and closures ensure product integrity and reduce cleaning validation needs<\/p>\r\n <\/div>\r\n <\/li>\r\n

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    Versatility <\/h3>\r\n

    Adaptable to all sizes of the AT-Closed Vial\u00ae (1\u201350 ml) <\/p>\r\n <\/div>\r\n <\/li>\r\n

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    Ideal for scale-up<\/h3>\r\n

    Built on modular technology platform for smooth scaling-up strategies<\/p>\r\n <\/div>\r\n <\/li>\r\n

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    Efficiency<\/h3>\r\n

    Rapid decontamination cycles (<20 minutes) and fast changeover due to minimal format parts<\/p>\r\n <\/div>\r\n <\/li>\r\n <\/ul>\r\n <\/div>\r\n <\/section>\r\n\r\n\n\n

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    Application<\/h5>\r\n

    Scale-up of filling capacity for ATMPs<\/h2>\r\n
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      For biopharmaceutical manufacturers, CROs, and C(D)MOs<\/h3>\n

      Suitable for biotech products like vaccines, or personalized medicines in small batch sizes.<\/p>\n <\/div>\r\n <\/div>\r\n <\/li>\r\n

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      For cell and gene therapy production<\/h3>\n

      Designed for handling intermediates such as viral vectors, plasmid DNA, and mRNA within an aseptic environment.<\/p>\n <\/div>\r\n <\/div>\r\n <\/li>\r\n

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      For scale-up from clinical to commercial<\/h3>\n

      Facilitates regulatory compliance and smooth transfer from small-scale (e.g. pure\u00b2 M1) to automated production through modular duplication.<\/p>\n <\/div>\r\n <\/div>\r\n <\/li>\r\n <\/ul>\r\n <\/div>\r\n <\/div>\r\n

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      Fill Finish<\/h5>\r\n

      The AT-Closed Vial\u00ae system<\/h2>\r\n

      The AT-Closed Vial\u00ae system enables a fully closed aseptic filling process.<\/p>\n

      At its core is the AT-Closed Vial\u00ae as the primary packaging, combined with the AT-Cap as closure, complemented by suitable filling lines and the single-use system AT-Assembly for sterile liquid transfers.<\/p>\n

      All components are fully aligned, ensuring a consistent, contamination-controlled, and scalable process.<\/p>\n <\/div>\r\n <\/div>\r\n

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      Process<\/h5>\r\n

      Fully automated fill and finish process within a Grade A isolator environment<\/h2>\r\n <\/header>\r\n
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