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Steady Flow of a Fluid Stream01:27

Steady Flow of a Fluid Stream

Consider a control volume, such as a pipe with solid boundaries, through which fluid flows and changes direction due to the impulse exerted by the resulting force from the pipe walls. In steady flow, the mass of fluid entering the control volume at a given time, t, with velocity v1, is equal to the mass leaving after infinitesimal time dt, with velocity v2.
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Related Experiment Video

Updated: May 11, 2026

Actin Co-Sedimentation Assay; for the Analysis of Protein Binding to F-Actin
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Actin Co-Sedimentation Assay; for the Analysis of Protein Binding to F-Actin

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BASIS: BioAnalysis SEDFIT integrated software for cGMP analysis of SV-AUC data.

Alexander E Yarawsky1, Erik S Gough1, Valeria Zai-Rose1

  • 1BioAnalysis, LLC, 3401 I Street Suite 206, Philadelphia, PA, 19134, USA.

European Biophysics Journal : EBJ
|February 8, 2024
PubMed
Summary

Sedimentation velocity analytical ultracentrifugation (SV-AUC) is now a gold standard for viral vector characterization. A new program, BASIS, enables cGMP-compliant SV-AUC data analysis for gene and cell therapies.

Keywords:
21 CFR Part 11Adeno-associated viral vectorsAntibodySEDFITTrace aggregatecGMP

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Area of Science:

  • Biophysical characterization
  • Analytical chemistry
  • Gene and cell therapy manufacturing

Background:

  • Sedimentation velocity analytical ultracentrifugation (SV-AUC) is a well-established technique for antibody therapeutic characterization.
  • SV-AUC is increasingly adopted in gene and cell therapy for viral vector analysis, particularly for determining capsid loading ratios.
  • Historically, SV-AUC has been limited to characterization, not release testing, in cGMP environments.

Purpose of the Study:

  • To address the challenges of implementing SV-AUC in a cGMP environment.
  • To introduce a novel program for compliant data handling and analysis of SV-AUC data.
  • To facilitate the use of SV-AUC for release testing in viral vector manufacturing.

Main Methods:

  • Implementation of SV-AUC in a current Good Manufacturing Practice (cGMP) setting.
  • Development and utilization of the "BASIS" program for data management.
  • Application of the SEDFIT software for SV-AUC data analysis.

Main Results:

  • SV-AUC is validated as a "gold standard" for viral vector capsid loading ratio determination.
  • The BASIS program provides 21 CFR Part 11-compliant data handling and analysis.
  • Challenges in adapting SV-AUC for cGMP release testing were overcome.

Conclusions:

  • SV-AUC can be successfully implemented for cGMP-compliant release testing of viral vectors.
  • The BASIS program and SEDFIT software support regulatory compliance for SV-AUC data.
  • This advancement supports the quality control of gene and cell therapies.