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Ultrafiltration/Cross-Flow-Filtration

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 NovaSetTM UF and MF cassettes.

Like the corresponding NovaSetTM-LS process development membrane cassettes, NovaSetTM pilot and process scale cassettes are available in a comprehensive range of options that are directly scalable from earlier development using the NovaSetTM cassettes. Optimized channel geometry and enhanced device rigidity ensures hydraulic performance is maintained when scaling up through the Ultra Crossflow filtration 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.

Prostream

Manufactured in a “single-cast”, uniquely controllable process:

Balanced flux and selectivity: this highly controllable manufacturing process enables tight control of the microporous/UF transition interface. The macroporous and UF zones of this membrane are now a finely controlled continuum. This controlled transition ensures:

  • No breakthrough of the UF skin, which maximizes selectivity performance
  • Enhanced macroporous substructure pore size and even transition, which maximizes flux
  • Reduced number of manufacturing steps equals lower cost and excellent consistency and reliability

Integral “cast-modification” of the membrane surface chemistry:

This is achieved by the addition of a second polymer into the pre-casting membrane solution and ensures total and consistent surface modification that delivers:

  • Very low protein binding due to the membranes neutral charge
  • Excellent chemical resistance

Hystream

Manufactured in a “single-cast”, uniquely controllable process:

Balanced flux and selectivity: this highly controllable manufacturing process enables tight control of the microporous/UF transition interface. The macroporous and UF zones of this membrane are now a finely controlled continuum. This controlled transition ensures:

  • No breakthrough of the UF skin, which maximizes selectivity performance
  • Enhanced macroporous substructure pore size and even transition, which maximizes flux
  • Reduced number of manufacturing steps equals lower cost and excellent consistency and reliability

Integral “cast-modification” of the membrane surface chemistry:

Selectively adding highly hydrophilic copolymer to the pre-casting membrane solution ensures a consistent, extremely hydrophilic surface modification that delivers:

  • Very low non-specific binding, suitable for high concentration streams with
  • highly fouling hydrophobic components in the process stream
  • Low protein binding
  • Good chemical resistance

More information:

 

 Hystream

 

  Novasep General

 

  NovaSet LS LHV Pilot System

 

  NovaSet LS LHV System

 

  NovaSet Cassette Holder

 

  NovaSet Cassettes

 

  NovaSet LS Cassettes

 

  ProStream

 

  Sius

 

  Sius Cassette

 

  Sius LS Cassette

 

  X-Flo76-HD

Animation: UF-Filtration

Novaset pilote system

Sius production system

Sius production system with casettes

Xflo 76 Labsystem

 
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