In todays newsletter we will focus on endotoxins.
What are Endotoxins?
Endotoxins are harmful substances found in the outer layer of certain bacteria (called Gram-negative bacteria). When these bacteria die or break apart, they release endotoxins into their surroundings. These toxins can be found in cell products through the introduction by contaminating bacteria, or from surfaces the cells touch that are not properly treated.
How we can help
At Allele Cell Therapy CDMO, we perform cGMP-compliant endotoxin testing using validated methods, i.e. the Limulus Amebocyte Lysate (LAL) test and recombinant Factor C (rFC). All of our testing follows USP <85>, the official guideline for bacterial endotoxins testing, which outlines standardized methods like the LAL test to ensure pharmaceutical products are safe and free from harmful bacterial toxins.
Figure 1. Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform
To ensure efficient and accurate testing, we use the Sievers Eclipse Bacterial Endotoxins Testing (BET) Platform (shown in Figure1), an automated microplate-based system that delivers high precision with minimal reagent use and a sensitivity down to 0.005 EU/mL. Our LAL assay detects endotoxins from gram-negative bacteria by utilizing blood cells from the horseshoe crab, which naturally clot in the presence of bacterial endotoxins as part of their immune defense.
There are two main ways to detect this reaction: the gel-clot method, where clot formation indicates endotoxin presence, and the chromogenic method, which measures a color change caused by enzymatic reactions triggered by endotoxins. At Allele, we specifically use the chromogenic method because it provides a precise, quantitative measure of endotoxin levels by correlating the intensity of the color produced to the amount of endotoxin present.
Why choose Allele?
Endotoxin testing is a complex and costly process that requires specialized reagents, validated equipment, trained personnel, and strict regulatory compliance. Performing these tests in-house can place a significant burden on resources and quality systems. Allele offers a cost-effective and reliable solution by providing access to advanced instrumentation, experienced staff, and fully validated protocols. We also conduct all our tests with cGMP compliance, in controlled environments, using strict standard operating procedures to ensure accuracy and regulatory adherence.
For more information on our Endotoxin tests, refer to our website: https://www.allelebiotech.com/cgmpipsclines/endotoxin-testing/
Stay tuned for the next newsletter where we will talk about Karotyping.
