Achieve higher flux, closed device and connectivity freedom

TangenX® SIUS® Gamma TFF Devices embody the performance and efficiency of SIUS® Cassettes in a convenient, fully assembled, closed, and sterile system. ​Acclaimed performance with up to 30% flux increase over conventional membranes, connectivity freedom, and a library of configurations, converge into one, simple TFF solution. ​ SIUS Gamma TFF Devices are ideal for gene therapy applications, bioburden-sensitive operations, and hazardous processes.

How Flat Sheet TFF Works

   READY-TO-USE 

Clamp-and-go connectivity

The diversity of connectivity options makes building closed systems a challenge. Genderless AseptiQuik® connectors featured on TangenX® SIUS® Gamma TFF Devices make life easier. Simply clamp the SIUS® Gamma TFF Device into a holder, connect to a flow path, and go. It's that easy.

Click on the links below to explore how to assemble SIUS Gamma TFF Devices.  TangenX® SIUS® hardware may be purchased separately.

 

  READY-TO-USE

Simple connectivity with ProConnex® Flow Paths

Custom ProConnex® Flow Paths complete your TFF solution. Flow paths are build using Class VI Bioprocess-grade materials that are BSE/TSE-free and Lot-traceable.

ProConnex® Filter Assemblies

CONFIGURED FOR YOU

Build a custom flow path to your specifications

  • Engineer-designed 
  • 可从超250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
READY TO SHIP

Order a pre-built and quality tested off-the shelf ProConnex® Flow Path stocked for rapid delivery.

  • 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
PLUG INTO EXISTING

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。

  HIGH PERFORMANCE

相当的性能,而兼具即取即用的便利性

Transition from SIUS® Cassettes to SIUS® Gamma TFF Devices seamlessly.​

膜性能不受暴露于伽马辐照的影响。​

When comparing performance of TangenX® SIUS® Cassettes (solid line) and TangenX® SIUS® Gamma TFF Devices (dashed line): ​

  • 滤液通量相当​
  • BSA 截留差异小于1 % 
  HIGH PERFORMANCE

Diverse options for diverse process needs

TangenX® SIUS® Gamma TFF Devices are offered with two membrane chemistries, two screen types, a wide selection of molecular weight cutoffs (MWCO), and a broad range of surface areas. With 96 configurations available, TangenX® SIUS® Gamma TFF Devices accommodate diverse process requirements for ultrafiltration and diafiltration applications from process development to commercial manufacturing.

ProStream Membrane

  • 中性电荷
  • 低蛋白结合
  • 出色的化学耐受性

HyStream Membrane

  • 亲水性
  • 低蛋白结合
  • 疏水性物质污染最小化
  READY TO SCALE FAST

Scalable from lab to process scale

TangenX® SIUS® Gamma Devices scale from  process development to large-scale manufacturing.  Molecular weight cut-offs (MWCO)s extend from 10 kD up to 100 kD. Mermbrane area range from 0.1 - 10 m2

截留分子量

10 kD, 30 kD, 50 kD, 100 kD

 

Membrane area

0.1, 0.5, 1.5, 2.5, 5, 10 m2

TangenX® SIUS® Gamma Devices

TangenX® SIUS®  Gamma TFF Devices 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.

Click on the links below to explore different features.

R 因子视频博客

TangenX® SIUS®  Gamma TFF Devices 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.

播放图标 视频海报

Manufacturing Centers of Excellence

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。

Repligen manufacturing sites are located in Massachusetts, California, and New Jersey in the United States and in Sweden, France, The Netherlands,  Germany and Estonia.

地点

Validated manufacturing

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. 

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

客户至上。

Repligen DNA 为您提供支持。我们的目标是提供卓越的客户体验,并为所有 Repligen 产品和服务高效成功的采用及实施提供支持。

  • Field Application Support
  • 客户服务
  • 现场服务工程师

还有问题吗?

资源

白皮书

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.
2020年7月

View whitepaper resources.