Cadence™ Single-Use TFF 모듈

A simpler, easier and safer single-use TFF solution for R&D, clinical or commercial manufacturing

Cadence single-use tangential flow filtration (TFF) modules are ready-to-use gamma irradiated cassette modules designed for single-use in Pall Allegro™ 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.

Cadence 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.

Integrating the process-proven Pall Omega™ polyethersulfone (PES) membrane, Cadence single-use TFF modules are available in scalable formats from 93 cm² up to 2.5 m² of membrane area.

Key Attributes

  • 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.

특징 이점
  • Cadence 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, Cadence 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
  • Cadence single-use TFF modules integrate the process-proven Omega PES membrane and are scalable.
  • Scalable formats, streamlining product development and process optimization
  • Tests have shown that the process performances of the Cadence single-use TFF modules are comparable to reusable Omega T-series cassettes, thus offering the flexibility to switch from single-use to reuse TFF options and vice-versa with limited validation work.
  • Improved process robustness
  • Improved process robustness

Schematic 1: Comparison of TFF operations, reusable cassettes versus single-use with Cadence modules

Product Platform

Cadence single-use TFF modules are available in five formats with the following membrane areas:

  • 93 cm²
  • 186 cm²
  • 0.1 m²
  • 0.5 m²
  • 2.5 m²

They integrate process-proven Pall Omega polyethersulfone (PES) membranes to offer high flux and selectivities. The Omega membranes have been specifically modified to minimize protein binding.

Cadence single-use TFF modules are available with Omega 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 Cadence holders and operated with the Allegro single-use TFF systems or with other single-use set-ups.

Quality Standards

  • 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>