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July 10, 2026Biotechnology ProgressOpen Access

Demonstration of nanofiltration‐based virus safety for AAV manufacturing using model viruses

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Authors

BBBrian BuesingTITomoki IgiDSDaniel Strauss

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Overview

Randomized trial demonstrates virus removal efficacy in adeno-associated virus manufacturing, suggesting safer biopharmaceutical products.

Key Points

  • This research aims to assess the effectiveness of nanofiltration in ensuring virus safety for AAV manufacturing processes.
  • Demonstration of a virus removal filter with a 35 nm mean pore size for AAV processes
  • Filtrations performed using porcine parvovirus and simian virus 40 as model contaminants
  • Filtration runs conducted at low pressure with a defined process pause to evaluate impact on viral clearance.
  • SV40 reduction observed to below the limit of detection following filtration runs
  • No reduction in porcine parvovirus detected, indicating effective removal of larger contaminating viruses
  • Maintained product yields for AAV products despite filtration process.

Cite This Study

Buesing et al. (2026) studied this question.

synapsesocial.com/papers/6a508b966eeac72a437a02fdhttps://doi.org/10.1002/btpr.88541
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