TangenX® SIUS® Gamma TFF Devices
With the performance and efficiency of SIUS® Cassettes, SIUS Gamma Devices come as a convenient, fully assembled, closed, and sterile system.
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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.
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.
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.
- Neutral charge
- 低いタンパク結合率
- Excellent chemical resistance
- 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.
ソリューション
Ohhhh, snap!
In a snap, you can build a closed TangenX® SIUS® Gamma flow path. It’s that easy.
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.
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.
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
KrosFlo® RS TFF Systems
The KrosFlo® RS are a series of tangential flow filtration (TFF) systems engineered for an era of new modalities. These systems are single-use and cGMP compliant with features like end-to-end automation, minimal hold-up volumes, and effortless scalability. Support automated ultrafiltration and diafiltration (UF/DF) processes for batch volume ranges of 35mL to 2000L.
ProConnex® Flow Paths for Systems
Expertly designed plug-and-play flow path
ProConnex® Flow Paths for TFF and Chromatography processes are single-use and engineered for optimum performance, reproducibility and time savings. System specific flow paths provide speed and reliability. Configured flow paths prioritize process requirements and sterility.
TangenX® SIUS® TFF Cassettes
SIUS® Cassettes are the first purpose-built single-use cassettes for tangential flow filtration, delivering unparalleled savings in filter cost, labor cost and buffer use.
TangenX SC TFF Device
TangenX® SC TFF Device: Revolutionize tangential flow filtration processes
Eliminate the hassle and inefficiency that comes with traditional downstream filtration cassette formats. Say goodbye to cassette holders, complex setups, continued torquing, wasted time, and product loss risks. Discover TangenX® SC, the future of TFF cassette solutions for ultrafiltration and diafiltration, designed to meet the demands of today’s TFF processes while dramatically reducing setup time and minimizing product loss risk.
リソース
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
