Endotoxin testing is an important process in various industries, including pharmaceuticals, medical devices, and biotechnology to ensure the safety and quality of products, as endotoxins can cause severe adverse reactions in humans. The Limulus Amebocyte Lysate (LAL) assay, is widely used for endotoxin detection. LAL is a mixture of proteins obtained from the amebocytes or cells of the horseshoe crab and causes a clotting reaction in the presence of endotoxins.

In this rapidmicrobiology special focus, we showcase the latest commercially available reagents, kits and instrumentation available for endotoxin testing.

When it comes to endotoxin testing, by whatever method, it is essential to have all labware, reagents, and laboratory water known to be free of endotoxin contamination. Endotoxin contamination in lab equipment and water supply can lead to false positives requiring the assay to be repeated, which is poor practice and not cost-effective, especially when dealing with expensive, short-life products such as cell and gene therapies. Dr. Kunal Kureja, Application Scientist for Lab Water at Sartorius AG, discusses what type of ultrapure water is suitable for use in endotoxin analysis and how to validate and verify it is endotoxin-free.

Various forces including corporate sustainability commitments, a need to improve lot-to-lot reagent standardisation and difficult matrices are among the issues bringing about market demand for a replacement of horseshoe crab-sourced LAL. Sustainability can be improved by using reduced quantities of animal derived LAL - the CMD αBET™ system is a fully integrated endotoxin testing solution that uses just a few microlitres of reagent to deliver results in under half the time of traditional tests without compromising on sensitivity or performance.

Another solution is Recombinant Factor C (rFC) which has been available for a number of years, Factor C is one of the enzymes responsible for activating the LAL cascade in the presence of endotoxins. In traditional LAL assays, Factor C is extracted from horseshoe crab blood but rFC is a genetically engineered version of Factor C produced using recombinant DNA technology without the need to harvest from horseshoe crabs.

Recently introduced is recombinant LAL (rLAL) which again is a synthetic version of the LAL enzyme produced using recombinant DNA technology. Discover from endotoxin experts Timothy Francis and Hesham Rashed at FUJIFILM Wako Chemicals U.S.A more about the new PYROSTAR™ Neo rLAL and why laboratories should be considering changing from LAL to rLAL reagents for some or all of their endotoxin testing.

Reduce variability and rate of invalid results with high throughput automated and semi-automated systems such as the Endosafe® Nexus 200™ and the ENDONEXT™ Endotoxin Detection Assay.

It's worth noting that specific brands and manufacturers may offer different software and kits, each with their unique features and capabilities. Therefore, it is advisable to consult the product documentation or contact the manufacturers for detailed information on their specific offerings.

Charles River Redefines Smart Automation with the Endosafe^® Nexus 200™

The Endosafe^® Nexus 200™ is the next generation of walkaway automated robotic technology for bacterial endotoxin testing. Capable of testing up to 120 samples per automated run, this fully enclosed system is data-integrity compliant while performing serial dilutions via LAL cartridge technology.
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Endotoxin Testing Using Recombinant Factors – Why Change?

Discover the advantages recombinant LAL (rLAL) might offer for BET, PYROSTAR™ Neo uses the three enzymes involved in the LAL cascade with virtually the same procedure as natural chromogenic LAL.
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Why Ultrapure Water is Essential for Consistent, Reproducible Endotoxin Results

Ultrapure water is particularly important for analytical analysis, as even small amounts of contaminants, such as endotoxins, can lead to false results.  Dr. Kunal Kureja, Application Scientist for Lab Water at Sartorius AG, shares his expertise in this area.
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High Throughput Endotoxin Testing With ENDONEXT^TM Full Automation

ENDONEXT™ allows you to fully automate your endotoxin testing. This solution based on recombinant Horseshoe Crab Factor C (rFC) gives you the performance needed for fast and efficient in-process control throughout your manufacturing process.
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Recombinant LAL Offers a Sustainable Alternative for Endotoxin Testing

PYROSTAR™ Neo is a new and reliable endotoxin detection reagent with high sensitivity and specificity. It’s 100% animal-free and offers a quantitative range of 0.001 to 50EU/mL for endotoxin detection in pharmaceuticals and medical devices.
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Testing Your Medical Devices with Endotoxin-Free Pipette Tips

Download the guide here to learn about preventing patient exposure to endotoxins where frequent and reliable testing for endotoxin levels on medical devices is required. The LAL method, is one such reliable test method used to guarantee patient safety and the risk-free use of medical devices.
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Revolutionize Your Endotoxin Testing With the αBET™ System

Introducing the CMD αBET™ system - a fully integrated endotoxin testing solution that uses just a few microlitres of reagent to deliver results in under half the time of traditional tests, without compromising on sensitivity or performance.
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Microbiology Proficiency Tests for TOC and Endotoxins

BIPEA offers three PT programs - Purified water for pharma applications: Endotoxins and TOC in purified water, Residual solvents in excipient: Ethylene oxide and Dioxane in Polyethylene glycol, Microbiology of pharmaceutical process water: total viable aerobic count in water.
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