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 
  • 250以上のコンポーネントから選択可能
    • 接続
    • Process reservoirs
    • 圧力変換器
    • 無菌コネクタ
READY TO SHIP

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

  • 個別に調査
  • 完全性テストが可能 
  • クリーンルーム組立
  • 二重包装
PLUG INTO EXISTING

ジェンダーレスコネクターの柔軟性を利用して、既存のフローパスにシームレスに接続します。

  HIGH PERFORMANCE

同等の性能をすぐに利用できる利便性

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

Membrane performance is unaffected by exposure to gamma irradiation. ​

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

  • Permeate flux is comparable​
  • BSA rejection varies by less than 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

  • Neutral charge
  • 低いタンパク結合率
  • Excellent chemical resistance

HyStream Membrane

  • 親水性
  • 低いタンパク結合率
  • minimal fouling with hydrophobic species
  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

分子量カットオフ

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ファクター動画ブログ

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.

再生アイコン 動画ポスター

Manufacturing Centers of Excellence

Repligenは、ISO 9001品質管理システムに基づいて、バイオ医薬品業界向けの製品を開発・製造しています。高品質で安定した、堅牢な製品をタイムリーに提供し、お客様の事業継続性を保証することを重視しています。

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

Locations

Validated manufacturing

高品質な製造

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. 

包括的なレギュラトリーサポートファイル

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

  • 製品情報
  • カセットのデザイン
  • 素材
  • 製品の性能
  • 安全に関する情報
  • 文書化システム
  • 製品の製造
  • 資格証明
  • 製造プロセスの検証
  • リリーステスト

お客様第一。

サポートは、Repligenという企業の遺伝子に組み込まれています。弊社の目標は、卓越した顧客体験を提供すること、そしてRepligenの製品やサービスの適用や導入を効率よく成功に導くためにサポートすることです。

  • Field Application Support
  • カスタマーサービス
  • フィールドサービスエンジニア

お問い合わせ

リソース

The R Factor
ホワイトペーパー

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社
2020年7月

View whitepaper resources.
レギュラトリーサポートファイル
View quality documents.