Endotoxin testing

Endotoxin Detection Assays

Endotoxin Detection Assays

Endotoxins, a type of pyrogen, are natural compounds found in the outer cell membrane of Gram-negative bacteria and impacts over 30 biological activities. Endotoxin can lead to cell death by initiating complement activation.

The Limulus Amebocyte Lysate (LAL) test was commercially introduced in the 1970s. LAL is derived from the blood cells, or amebocytes, of the horseshoe crab, Limulus polyphemus. Frederick Bang and Jack Levin observed that blood cells from horseshoe crabs were found to clot in the presence of endotoxin, and this technology was used in the development of endotoxin detection assays.

Today, endotoxin tests are performed on raw and in-process materials, and for the final release of products in the pharmaceutical and medical device industries.

Using extensive experience with endotoxin detection and its regulatory requirements, Lonza has been able to deliver innovative and time-saving tools for both the pharmaceutical and research markets.

Their offerings include:

  • PYROGENT™ Gel Clot LAL Assays
  • PYROGENT™ – 5000 Kinetic Turbidimetric LAL Assays
  • QCL-1000™ Endpoint Chromogenic LAL Assays
  • Kinetic-QCL™ Kinetic Chromogenic LAL Assays
  • PyroGene™ rFC Endpoint Chromogenic Fluorescent Assay

For detailed product information, contact us, or click here.

Accessory Items

Accessory Items

In addition to the endotoxin detection assay kits, instruments and software, Lonza offers all of the accessory items necessary to run endotoxin detection assays.

Many of the items have been tested with the Kinetic-QCL™ Kinetic Chromogenic LAL Assay to help ensure their compatibility with our endotoxin detection methods. They also offer products such as Endotoxin Challenge Vials™ to help customers with oven depyrogenation validations.

For more details, please see here.