A simpler, easier and safer single-use TFF solution for R&D, clinical or commercial manufacturing
ケイデンス single-use tangential flow filtration (TFF) modules are ready-to-use gamma irradiated cassette modules designed for single-use in Pall アレグロ™ single-use TFF systems and can also be integrated into other single-use TFF set-ups.They provide ease-of-use, quick turnaround and increased flexibility, safety and containment in cGMP operations.
ケイデンス single-use TFF modules can be easily implemented in single-use TFF systems for concentration and diafiltration steps from R&D to commercial production of biotech products or vaccines.
Simpler and easier solutions:preassembled, ready-to-use modules for easy integration into single-use TFF systems.
Safer solutions:single-use, gamma irradiated, contained modules for product and operator safety.
Designed for use in our easy-to-use, compact SUTFF systems
ケイデンス single-use TFF modules are delivered as preassembled modules that have been gamma irradiated at ≥ 25 kGy
Ease of installation and integration in single-use TFF systems
Supplied preconditioned, stored in water and gamma irradiated, the modules do not require comprehensive conditioning steps prior to use (see schematic 1).Typically less than 20 L/m² flush volumes are required to reach TOC levels below 1 ppm.
Improved productivity, reducing downtime and allowing focus on product processing operations only
No chemical handling
Reduction of buffer or WFI consumption
Designed for fully single-use operation, ケイデンス single-use TFF modules can provide post-use containment during the single-use fluid flow path disassembly.
Increased process, product and operator safety
No cross contamination
Post-use containment of hazardous product
ケイデンス single-use TFF modules integrate the process-proven オメガ PES membrane and are scalable.
Scalable formats, streamlining product development and process optimization
Tests have shown that the process performances of the ケイデンス single-use TFF modules are comparable to reusable オメガ T-series cassettes, thus offering the flexibility to switch from single-use to reuse TFF options and vice-バーサ with limited validation work.
Improved process robustness
Improved process robustness
Schematic 1:Comparison of TFF operations, reusable cassettes versus single-use with ケイデンス modules
ケイデンス single-use TFF modules are available in five formats with the following membrane areas:
They integrate process-proven Pall オメガ polyethersulfone (PES) membranes to offer high flux and selectivities.The オメガ membranes have been specifically modified to minimize protein binding.
ケイデンス single-use TFF modules are available with オメガ membrane in three different nominal molecular weight cutoffs (NMWC) - 10 kD, 30 kD and 100 kD - meeting the majority of the needs for single-use TFF applications in the biotech and vaccines industries.
The single-use TFF modules can be installed and torqued into specially designed ケイデンス holders and operated with the アレグロ single-use TFF systems or with other single-use set-ups.
Manufactured in a controlled environment
Manufactured under a quality management system certified to ISO 9001 standards
Supplied with a Certificate of Quality confirming the quality standards and quality control tests performed by Pall
The fluid path meets all regulatory requirements for:
Biological Reactivity Tests (in vivo) for Class VI-70°C Plastics, USP <88>
Biological Reactivity Tests (in vitro) for Cytotoxicity, USP <87>
Typical applications for アレグロ single-use TFF solutions with ケイデンス single-use TFF modules are in the downstream processing operations for the concentration and/or diafiltration of biological products in the biotech and vaccines industries.
The ケイデンス single-use TFF modules can be implemented from R&D lab to commercial production.Fully scalable, the drug product development and validation steps can be streamlined.
Purpose-designed for single-use, they are especially recommended for multipurpose facilities or CMOs, for clinical material or for commercial production with batch sizes up to several hundred liters.
For further application details, please read this application note, co-authored with RentschlerBiotechnologie GmbH: