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NovaSetCassettes for Pilot Scale and Commercial Applications

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At pilot stage, the primary membrane candidate has been chosen, as process parameters. Typically at this stage, the production method is being verified and production materials produced for toxicology or pre-clinical trials and predictable scalability is imperative. In order to facilitate the manufacturing life cycle of a successful therapeutic candidate, cGMP manufacturing needs to begin at relatively small scale to facilitate human clinical trials. Manufacturing material for this early pilot scale manufacturing can easily and effectively be accomplished using the TangenX NovaSet UF and MF cassettes. Like the corresponding NovaSet-LS process development membrane cassettes, NovaSet pilot and process scale cassettes are available in a comprehensive range of options that are directly scalable from earlier development using the NovaSet cassettes.

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Optimized channel geometry and enhanced device rigidity ensures hydraulic performance is maintained when scaling up through the NovaSet-LS and NovaSet cassette family resulting in optimal and reproducible scaling performance. Additionally, each cassette undergoes rigorous QA lot release testing to verify its meets specification. Cassettes are tested for both air integrity and for their hydrodynamic performance. This testing ensures cassette-to-cassette consistency, resulting in scalable process development and reproducible manufacturing. Graph 1 shows the pressure drop vs. cross-flow specification for the NovaSet cassettes. Graph 2 shows the TMP vs. water flux for a typical 10 kD NovaSet Cassette.

Benefit of Selecting NovaSet Cassettes:

  • Optimized channel geometry
  • Reliable scale-up performance
  • Rigid cassette design