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Filtration00:53

Filtration

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Filtration is a physical separation process that involves passing a suspension through a porous medium to separate solids from fluids. During filtration, solids collect on the porous medium while liquids, also collectively known as the filtrate, pass through. The filtration medium is selected based on the filtration purpose, quantity, and nature of the precipitate. The general criteria for a suitable filtering medium are that it is inert, mechanically strong, nonabsorbent toward dissolved...
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Optimizing virus filtration for continuous processing using serial filtration at high area ratio.

Sal Giglia1, Ben Cacace1, Jacob McCoskey1

  • 1MilliporeSigma, Bedford, Massachusetts, USA.

Biotechnology and Bioengineering
|July 31, 2024
PubMed
Summary
This summary is machine-generated.

Continuous bioprocessing uses serial virus filtration with a high filter area ratio to overcome low flux challenges. This novel approach enhances virus removal efficiency and extends filter lifespan in biopharmaceutical manufacturing.

Keywords:
continuous processingvirus clearancevirus filtervirus filtration

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Engineering
  • Filtration Technology

Background:

  • Continuous bioprocessing offers advantages over batch operations but faces challenges in integrating traditional steps like virus filtration.
  • Low flux conditions in continuous virus filtration can compromise viral retention performance, hindering adoption.
  • Existing methods struggle to maintain high viral clearance in continuous flow systems.

Purpose of the Study:

  • To develop and evaluate a novel serial virus filtration approach for continuous bioprocessing.
  • To achieve target virus retention levels under continuous operating conditions.
  • To assess the impact of filter area ratio on performance and longevity.

Main Methods:

  • Continuous operation of virus filters in a serial configuration for 200 hours.
  • Utilized a high area ratio (13:1) between the first and second stage filters.
  • Operated at a first stage flux of 5 L/m²/h, challenging typical continuous filtration parameters.

Main Results:

  • Achieved a minute virus of mice (MVM) log reduction value (LRV) of ≥6.7 across the serial filtration train.
  • The first stage filter provided ~4 LRV, while the second stage filtrate showed no detectable virus.
  • The first stage filter controlled fouling and filter train lifespan, demonstrating effective protection by the serial setup.

Conclusions:

  • Serial virus filtration with a high area ratio is a viable strategy to enhance viral clearance in continuous bioprocessing.
  • This approach overcomes the limitations of low flux operation and improves overall process efficiency and safety.
  • The findings provide critical insights for optimizing continuous virus filtration trains in biomanufacturing.