Endotoxin Testing Services

Endotoxin is an exogenous pyrogen, which is generated by bacterial death or autolysis. Endotoxin enters the bloodstream and causes a certain degree of damage or even fatality to the host after a series of chain reactions. Therefore, any drugs that enter the human body, including parenteral drugs and injection devices, must be tested for endotoxin level before being released to the market.

To meet the safety needs of pharmaceuticals, biologics and medical devices, Creative BioMart offers a full range of endotoxin testing methods:

Rabbit Pyrogen Test (RPT)

Bacterial Endotoxin Test (BET)

BET is also known as Limulus Amebocyte Lysate (LAL) assay.

Recombinant Factor C (rFC) Assay

rFC assay is the evolution of BET assay, which is the activation of a recombinant form of factor C by endotoxin, thereby completing the thrombin-enhanced cascade of horseshoe crabs. The rFC assay acts through a single enzymatic step as compared to the multi-step enzymatic process required by BET assays.

Monocyte Activation Test (MAT)

MAT is developed based on the principles of the human immune system response.

EndoLISA

EndoLISA based on an endotoxin selective precoated microplate and a specific detection reagent which based on factor C.

The comparison of the methods is shown in the following table.

Method Advantages Disadvantages
RPT
  • Close to the real situation of the human body
  • Reflecting the complex heating process of mammals caused by pyrogens
  • Can detect bacterial endotoxin, non-bacterial endotoxin pyrogens
  • Complex and time consuming
  • Large individual differences
  • Low sensitivity
  • Low repeatability
  • Not quantifiable
BET
  • Insensitive to endotoxin other than Gram-negative bacteria
  • False positive reaction
  • Simple and fast
  • high sensitivity
  • Good repeatability
  • Quantifiable
rCF and MAT
  • Not dependent on animals
  • Based on human fever response
  • Can detect endotoxin and non-endotoxin pyrogens
  • Raw material from blood banks, batch size limited

In practice, RPT has been gradually replaced by BET. However, it is not yet possible to completely replace RPT because of some shortcomings of BET itself. The development of rCF and MAT not only has eased the excessive dependence on horseshoe crabs, but provides more comprehensive approaches to detect pyrogens in biological samples.

In Creative BioMart, we provide a full range of services for endotoxin testing.

Our strengths are as follows:

Except for all the above, we have a well-equipped laboratory, which can meet the needs of various endotoxin test methods, and a large and experienced team of scientists dedicated to work with researchers around the world, to meet their needs. If you are interested in our services, please contact us for more details.

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