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Updated: Jun 9, 2026

Isolation of Low Endotoxin Content Extracellular Vesicles Derived from Cancer Cell Lines

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Published on: February 17, 2023

Endotoxin removal by virus filters.

Cui Wang¹, Shoumiao Wang¹, Shiyun Peng¹

¹Downstream Process Development (DSPD), WuXi Biologics, Shanghai, China.

Biotechnology Progress

|June 8, 2026

Summary

Commercial virus filters effectively remove endotoxins from protein solutions, achieving high recovery rates. This novel application offers a promising new method for ensuring drug product safety in biopharmaceutical manufacturing.

Keywords:

acidic proteins clinical manufacturing endotoxin clearance endotoxin removal high‐pH sensitive proteins preclinical manufacturing virus filtration

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Air-sampled Filter Analysis for Endotoxins and DNA Content

Air-sampled Filter Analysis for Endotoxins and DNA Content

Published on: March 7, 2016

Area of Science:

Biopharmaceutical Manufacturing
Drug Product Safety
Protein Therapeutics

Background:

Endotoxins are pyrogenic contaminants posing significant risks to drug product safety.
Current endotoxin removal methods often compromise protein recovery or operational simplicity.
Developing efficient and compatible endotoxin decontamination techniques for protein solutions is crucial.

Purpose of the Study:

To investigate the efficacy of commercial virus filters for endotoxin clearance in protein solutions.
To compare the performance of virus filters against established membrane technologies for endotoxin removal.
To elucidate the removal mechanisms of virus filters for endotoxins in monoclonal antibody solutions.

Main Methods:

Systematic evaluation of virus filters from multiple manufacturers.
Testing across various initial endotoxin concentrations and buffer conditions (pH 5.5 and 7.5).
Comparative analysis with Mustang E and Mustang Q membranes.
Dynamic light scattering to characterize endotoxin-monoclonal antibody complexes.

Main Results:

Planova BioEX and Valpha PES virus filters achieved 88%-99% endotoxin reduction with >95% protein recovery.
Virus filters demonstrated superior endotoxin removal compared to Mustang membranes at low pH (5.5).
Size exclusion (based on ~20 nm pore size) was identified as the primary removal mechanism for virus filters.

Conclusions:

Virus filtration is a viable alternative for endotoxin removal in preclinical protein processing.
This method is particularly suitable for pH-sensitive proteins and acidic proteins.
Virus filtration expands the available options for endotoxin clearance in clinical manufacturing.