IVD

Endotoxin Testing

In situations where the body is excessively or systemically exposed to lipopolysaccharides (LPS), a systemic inflammatory reaction can occur, leading to various pathophysiological effects. Detecting and removing endotoxins from products such as injectables, drugs, and other biological and pharmaceutical items is crucial. America Diagnostics offers reliable, efficient, and sustainable endotoxin testing through extensive research and cutting-edge technology.

Background

Endotoxins, also known as LPS, originate from the cell membranes of Gram-negative bacteria and play a role in their organization and stability. These endotoxins are continuously released into the environment during cell death, growth, and division. Rather than directly affecting cells or organs, endotoxins activate the immune system, particularly monocytes and macrophages, leading to the release of pro-inflammatory mediators like tumor necrosis factor (TNF), interleukin (IL)-6, and IL-1. Consequently, endotoxins are widespread and elicit a wide range of pathophysiological effects.

Chemical and Physical Properties of Endotoxin

Endotoxins consist of a hydrophilic polysaccharide moiety covalently linked to a hydrophobic lipid moiety (lipid A). Most species’ endotoxins have three distinct regions: the O-antigen region, a core oligosaccharide, and lipid A (Fig 1). The biological activities of endotoxin, including its toxicity, primarily stem from lipid A.[1,2,3]

Properties of Endotoxin

• Ubiquitous in nature
• Potent toxicity
• Stable under extreme conditions (autoclave etc)
• Occur during the manufacturing process

Main Services

1. Endotoxin Detection Service: America Diagnostics provides sensitive and accurate methods for endotoxin detection. Mail or drop off the sample, America Diagnostics will send you a report in 48 hours with quantitative data.
2. Endotoxin Removal Service: Reduce endotoxin levels effectively in your products or instruments. The process and method may vary depending on the testing products, for example, we offer endotoxin removal via filtration of the water through the endotoxin removal resin in our GMP facility.

Usage of Endotoxin Testing

• Plasmid, synthesize peptide, purified proteins etc, all biological products used in cell culture or pharmaceutic R&D.
• Injectables or parenteral products
• Validation of depyrogenation processes
• Radiopharmaceuticals and cytotoxic agents

Platform Advantages

• Variety of endotoxin detection and removal assays: in-house Endotoxin detection kit based on recombinant rFc, LAL assay etc.
• Simultaneous testing of multiple samples (ELISA based rFc assay can process up to 86 samples in one run).
• Customized test schemes based on sample characteristics
• Highly sensitive detection and accurate results (linear range 0.005 to 0.5 EU/mL).

For more detailed information, feel free to contact us or submit an inquiry.

References

[1] Skočková, V., Vašíček, O., Sychrová, E., Sovadinová, I., Babica, P., Sindlerova, L. (2023) Cyanobacterial Harmful Bloom Lipopolysaccharides Induce Pro-Inflammatory Effects in Immune and Intestinal Epithelial Cells In Vitro Toxins 15.

[2] Hashim, N., Babiker, R., Mohammed, R., Chaitanya, N., Rahman, M., M., Gismalla, B. (2024) Highlighting the Effect of Pro-inflammatory Mediators in the Pathogenesis of Periodontal Diseases and Alzheimer’s Disease Journal of Pharmacy & Bioallied Sciences 16, S1120-S1128.

[3] Skočková, V., Raptová, P., Pospíchalová, K., Sovadinová, I., Sychrová, E., Smutná, M., Hilscherová, K., Babica, P., Sindlerova, L. (2023) Cyanobacterial harmful bloom lipopolysaccharides: pro-inflammatory effects on epithelial and immune cells in vitro Archives of Toxicology 98, 481-491.

For Research Use Only, Not for Clinical Use