TangenX® 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® SIUS® SINGLE-USE TFF CASSETTES
TangenX® SIUS® Single-use TFF Cassettes deliver the performance of reusable cassettes with single-use convenience at a fraction of the cost.
従来のTFFでは、プロセスで使用されたフィルターは定置洗浄（CIP）により毎回洗浄されます。これには、システムの容量、原材料、エネルギー、時間を多く費やす必要があります。
Validated for GMP use, TangenX® SIUS® Single-use TFF Cassettes are a convenient alternative delivered ready to use with either ProStream or HyStream membranes, and a complete range of pore sizes and flow-channel configurations. Pre-sanitized and packaged with 0.2M NaOH, the cassettes are engineered with optimized channel geometry and enhanced device rigidity to ensure that hydraulic performance is maintained during processing and scale-up.
交換可能
With TangenX® PRO Reusable TFF Cassettes - same channel geometry, same membrane chemistry
互換性
主要サプライヤー（Millipore社、Pall社、Sartorius社）製のカセットホルダーでの使用可
GMP向けに検証済み
規制ガイドラインに準拠する検証ガイドとコンプライアンス証明書を提供
比類なき低コスト
50% reduction in labor cost
75% reduction in buffer use
80% reduction in filter cost
スケーラブル
プロセス開発から商業生産まで
事前消毒済み
0.2MNaOHでパッケージ
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。
TangenX® SIUS® PD FOR PROCESS DEVELOPMENT
During process development, the aim is to select the most promising membrane candidates while making related decisions regarding feed pressure, trans-membrane pressure (TMP) and screen geometry. TangenX® SIUS® PD Single-use TFF Cassettes save valuable time and resources by eliminating cleaning cycles between experiments. Designed for processing volumes from tens of milliliters to several liters, TangenX® SIUS® PD Cassettes enable linear scale processing over a wide range of operating volumes.
To ensure fit with cassette holders from other manufacturers, TangenX® SIUS® PD Single-use TFF Cassettes are offered with two different notch patterns at the end of the cassette.
Shop now for TangenX® PD Cassettes
メンブレン
表面積
0.01 m2
0.02 m2
0.10 m2
TangenX® SIUS® PD with standard notch
0.850インチ（21.59mm）オフセット
このフォーマットは以下のカセットクランプおよびホルダーに適合します。
- TangenX® SIUS® PD Cassette Clamps
- TangenX® PRO PD Cassette Holders
- Pall - Centramateホルダー（CM018LV、FS001K10）
TangenX® SIUS® PD with offset notch
0.756インチ（19.21mm）オフセット
このフォーマットは以下のサードパーティ製カセットホルダーに適合します。
- Sartorius - Sartocon Sliceホルダー（17525-01、17521-02）
- GE - Kvick Labホルダー（KLPH01SSU、KLHR0105000SS）
- Millipore - Pelliconミニホルダー（XX42PMINI）
TangenX® SIUS® FOR SCALE-UP AND COMMERCIAL MANUFACTURING
メンブレン
表面積
0.5 m2
1.5 m2
2.5 m2
When the primary membrane candidate has already been chosen as a process parameter, the production method needs to be verified and production materials produced for toxicology or pre-clinical trials, and ultimately for large-scale commercial production. TangenX® SIUS® Single-use TFF Cassettes provide reliable cassette-to-cassette consistency, ensuring that processes can scale to commercial production levels.
比類のないプロセス効率とコスト効率
フィルターのコストを80%削減
人件費を50%削減
バッファー使用量を75%削減
プロセス開発から商業規模までスケーラブルに対応
プロセス量とメンブレンの面積により、ベンチから生産スケールまでの規模が決まります。
複数チャンネル構成
Tangential flow filtration cassettes create turbulence at the membrane's surface and minimize fouling. The result is an increase in performance with a higher permeate flux. TangenX® SIUS® Cassettes are offered in three different channel configurations to best suit the application. The channel configuration refers to the type of turbulence promoter incorporated into the feed channel of a cassette.
L Screen - A medium channel or L screen is offered in all TangenX® SIUS® Cassette formats. The screen creates turbulence at the membrane's surface ensuring outstanding permeate flux with minimal fouling. This channel configuration requires the lowest pumping rate and yields the highest cross flow velocity. This type of channel is best suited for clarified feed streams over a wide range of viscosities.
EP Screen - A coarser screen channel, the EP channel is offered in all TangenX® SIUS® Cassettes. The screen geometry of this single-use cassette can process feed streams with a higher viscosity and reduce the overall pressure drop. It is scalable from 100cm2 to 2.5m2, packaged sanitized and compatible with existing cassette holders and FPIs. This type of channel is best suited for processes that use shear sensitive feed streams.
J Channel - A open channel or J channel is offered in all TangenX® SIUS® Cassettes. A 0.5mm flow spacer separating the membrane creates an open feed flow channel. This type of channel creates the least amount of turbulence while still minimizing fouling. It also requires the highest pumping rate to pass particulates. This type of channel is best suited for unclarified feed streams and is used for processes such as cell harvest operation.
検証済みの製造
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:
- 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
TangenX® SIUS® HARDWARE
TangenX® SIUS® TFF Hardware includes:
- SIUS® cassette clamps
- SIUS® filter plate inserts
リソース
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