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TangenX® SIUS® Gamma Flat Sheet Cassettes

TangenX® SIUS® Gamma filtration devices harness the performance and efficiencies of TangenX® SIUS® membranes and cassettes with the convenience of a fully assembled, closed and irradiated system.

在连接便利的封闭式设备中进行TFF

TangenX® SIUS® Gamma filtration devices harness the performance and efficiencies of TangenX® SIUS® membranes and cassettes with the convenience of a fully assembled, closed and irradiated system.

Acclaimed performance with up to a 30% flux increase over conventional membranes, connectivity freedom and a library of molecular weight cutoffs, surface areas, chemistries and screen types converge into one, simple single-use flat-sheet solution. Manufactured under ISO 9001, every unit is integrity tested and quality tested.

Building closed systems can be challenging given the diversity of connectivity options available. TangenX® SIUS® Gamma Cassettes make your life easier by giving you connectivity choices. Either configure a ProConnex® flow path based on your specification, select a pre-built ProConnex® flow path that is ready-to-ship or simply plug the filtration device into your existing flow path with genderless AseptiQuik® connectors.

Repligen在ISO 9001质量管理体系下开发和生产用于生物制药行业的产品。我们专注于及时交付高质量、一致且稳健的产品,以确保我们客户的业务连续性。

关于Repligen生产

夹上即可运行,就是这么简单!

The TangenX® SIUS® Gamma device arrives as a fully assembled closed device, including cassette, manifold, clamps, tubing and genderless AseptiQuik® connectors. Simply clamp into a holder, make your flow path connections and run your process.

 

 

 

 

部件

  1. 六角螺母 
  2. 金属垫片
  3. 3. 2" or 1" 螺杆间隔器
  4. 夹具顶板
  5. TangenX™ SIUS™ Gamma膜包
  6. 歧路
  7. 夹具底板
为您量身配置设计

从超400种经质量检测的部件库中选择构建定制规格的流路。

configured_for_you.png

兼容所有市售
即插即用,兼容现有设备

采用无公母头区分的灵活快接头,可无缝连接至您现有的流路。

plug_into_existing_gamma.png

验证用于GMP工艺
现货供应,随时准备发货

订购预配置组装且经质量检测的现货 ProConnex® 流路,可直接发货。

ready_to_ship_gamma.png

适合基因治疗
AAV工艺的理想选择,其通常体积较大,需在层析前浓缩20-60倍
高质量生产

在符合ISO指南的ISO 7级洁净室内生产
确定的货期

全球支持

Repligen现场应用专家提供从咨询到执行的全面支持

Tangenx® Innovation Inside

 

满足您多样化工艺需求的多样化选择

宽泛的截留分子量、膜表面积规格以及多种膜材质和筛网类型,可为满足您不同的工艺需求,提供多样化的选择。

From sticky proteins to high concentration samples and from process development to manufacturing, the TangenX® SIUS® Gamma provides a closed solution. Scale, solve and move forward with one flat-sheet platform.

膜化学材质:

筛网:

 

观看网络研讨会

TangenX® SIUS® Gamma TFF cassettes incorporate the performance-leading TangenX® TFF membrane and cassette manufacturing technologies into a closed, gamma-irradiated, single-use assembly. Genderless, aseptic connections easily integrate into your current UF/DF flow path, and a library of 64 MWCO and surface area configurations provide rich process options.

 

申请报价

相当的性能,而兼具即取即用的便利性

 

 

Seamless transition from TangenX® SIUS® Flat Sheet Cassette to TangenX® SIUS® Gamma Closed TFF Cassette

工艺体积 vs. 膜表面积 @ 200 L/m2 单位体积吞吐量

ProConnex®流路,进一步提升功能性和便利性

定制 ProConnex® 流路 ,完整您的TFF方案

定制化

  • 按客户所需规格,进行工程设计
  • 可从超400种部件的物料库中进行选择
    • 接头
    • 工艺容器
    • 压力传感器
    • 无菌接头

高质量

  • 单个独立检测
  • 可提供完整性检测
  • 洁净室组装
  • 双层包装袋包装

生物工艺级材料

  • VI级
  • 无BSE/TSE
  • 批次可追溯

夹上即可运行

  • 完整流路或普适性即插管路套件

经验证的生产过程

高质量生产

TangenX® Cassettes are manufactured in a fully validated and documented manufacturing process according to the principles of cGMP. Each cassette comes with a Quality Assurance Certificate. 

quality-assurance-certificate.jpg

完整法规支持文件

Each TangenX® TFF Cassette is supported by a Regulatory Support File (available upon request) that includes:

  • 产品信息
  • 膜包设计
  • 结构材料
  • 产品性能
  • 安全信息
  • 文件系统
  • 产品生产
  • 质量确认
  • 生产工艺验证
  • 出厂检测

 

资源

全部展开

AAV Studies Deploying a Closed, Irradiated, Single-use Flat Sheet TFF Device

by David Bianchi, Carl Breuning, Michael LaBreck, Shelly Parra, Mary Jo Wojtusik, Repligen Corporation 
Alex Meola, Michael Mercaldi, Thomas Thiers, Homology, Medicines Inc. 

Repligen Corporation
Homology, Medicines Inc.
July 2020