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Endotoxin Activity Assay for the Detection of Whole Blood Endotoxemia in Critically Ill Patients
Published on: June 24, 2019
A multicenter comparison study between the Endosafe PTS rapid-release testing system and traditional methods for
A P Gee1, D Sumstad, J Stanson
1Center for Cell and Gene Therapy (CAGT), Baylor College of Medicine, Texas Children's Hospital, Houston, Texas 77030, USA. apgee@txccc.org
Cytotherapy
|June 25, 2008
Summary
The Endosafe portable test system (PTS) offers rapid, reliable endotoxin detection for cell therapies. This chromogenic Limulus amebocyte lysate (LAL) assay provides quantitative results in 15 minutes, streamlining product release.
Area of Science:
- Biotechnology
- Analytical Chemistry
- Cell Therapy Manufacturing
Background:
- Current endotoxin testing methods for cell therapies are time-consuming and labor-intensive.
- Rapid-release testing is crucial for time-sensitive cell-therapy products.
- The Endosafe portable test system (PTS) is a rapid, portable endotoxin detection system.
Purpose of the Study:
- To evaluate the performance of the Endosafe PTS for endotoxin detection in cell-therapy products.
- To compare the Endosafe PTS with traditional Limulus amebocyte lysate (LAL) assays.
- To assess the suitability of the Endosafe PTS for routine release testing of cell therapies.
Main Methods:
- Side-by-side testing of Endosafe PTS and traditional LAL methods was conducted at two facilities.
- Standard dilutions of cell-therapy products and fabricated endotoxin-positive samples were tested.
- Testing involved triplicate measurements using specified endotoxin unit/mL (EU/mL) sensitivity cartridges.
Main Results:
- Endotoxin detection between the Endosafe PTS and traditional LAL methods was equivalent in most cases.
- Paired test results were analyzed based on established criteria.
- Blinded testing of fabricated samples was performed.
Conclusions:
- The Endosafe system provides reliable endotoxin detection results for cell-therapy products.
- The Endosafe PTS is suitable for the release of time-sensitive cell-therapy products.
- Rapid endotoxin testing can improve the efficiency of cell therapy manufacturing.
