Endotoksintesting

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.

Instruments & Software

Instruments & Software

Lonza is the industry leader in innovations for endotoxin detection products, services and software. Using their extensive experience with endotoxin detection and its regulatory requirements, they developed an integrated system to support quantitative endotoxin detection. Each system component has been validated and can be verified.

Two plate readers have been validated as part of our quantitative endotoxin detection systems. These 96-well plate readers feature sample compartments with uniform temperature from well to well, and both readers seamlessly interface with their WinKQCL software.

Endotoxin Testing Services

Endotoxin Testing Services

Lonza's Endotoxin Testing Service combines their expertise with full service reporting, offering both research and pharmaceutical customers’ routine and customized endotoxin testing.

Lonza’s Endotoxin Detection Testing laboratories are located in their cGMP-certified manufacturing plants in Walkersville, MD USA and in Verviers, Belgium. The Endotoxin Testing Service is designed for customers from the pharmaceutical industry, medical device companies, research and environmental laboratories.

Pharmaceutical-grade testing is offered both in the U.S. and Europe. This service includes all of the validation steps required during a product validation program and requested by regulatory authorities to be compliant with the current harmonized Bacterial Endotoxins Test (BET) as defined in the U.S. Pharmacopeia (USP) and European Pharmacopeia (EP). For the medical device industry, the service complies with the USP Monograph General Chapter, Citation <161> Transfusion and Infusion Assemblies and Similar Medical Devices.

For more information click here.