Endotoxin Testing and Bioprocessing Media
Detect and control endotoxin in raw materials, water, in-process samples and finished product, and source bioprocessing media for protein production and cell and gene therapy. Available across the UAE, Saudi Arabia and Egypt.
Why endotoxin has to be controlled at every step
Endotoxins are lipopolysaccharides from the outer membrane of Gram-negative bacteria. In the bloodstream they cause fever and, at higher doses, serious inflammatory reactions, so every injectable drug and implantable medical device must be shown to stay within its endotoxin limit.
Endotoxin is not removed by killing bacteria. It is heat-stable, survives standard steam sterilisation and can be carried in on raw materials, water and equipment. Control therefore depends on testing at each stage: incoming materials, water for injection, in-process samples and the final product.
The test itself has pitfalls. Product components can inhibit or enhance the reaction, so each product needs a validated dilution that removes interference while staying within the maximum valid dilution. Some biologic formulations also show reduced endotoxin recovery, which has to be understood before results can be trusted.
Test methods and how Lonza covers them
The pharmacopoeias describe the bacterial endotoxins test (USP <85>, Ph. Eur. 2.6.14) using Limulus amebocyte lysate (LAL), a reagent from horseshoe crab blood, in gel-clot, turbidimetric and chromogenic formats. Recombinant Factor C (rFC) reproduces the first enzyme of that cascade without animal material and is described in Ph. Eur. 2.6.32. The monocyte activation test (MAT), Ph. Eur. 2.6.30, uses human immune cells and also detects pyrogens that are not endotoxins.
Lonza offers endotoxin and pyrogen testing for raw materials, in-process samples and manufactured product, meeting regulatory requirements for injectable drugs and implantable medical devices. Its MODA® software replaces paper records in QC microbiology, covering environmental monitoring, utility testing and product testing with on-demand reporting and trending.
For manufacturers growing cells, Lonza also supplies bioprocessing media for protein production and for cell and gene therapy applications.
Endotoxin testing
Assays and reagents for raw materials, water, in-process samples and finished product.
Pyrogen testing
Pyrogen control for injectable drugs and implantable medical devices.
MODA® paperless QC
Electronic records and trending for environmental, utility and product testing.
Bioprocessing media
Media for protein production and cell and gene therapy.
Partner technology
Lonza covers endotoxin and pyrogen testing, the QC records around it, and the media used upstream.
Frequently asked questions
What is the difference between LAL and recombinant Factor C?
LAL is made from horseshoe crab blood and contains the whole clotting cascade. Recombinant Factor C reproduces only the first, endotoxin-specific enzyme, uses no animal material, and is not triggered by the glucans that can activate LAL.
When is the monocyte activation test used?
MAT detects both endotoxin and non-endotoxin pyrogens using human immune cells. It is used where pyrogens other than endotoxin are a concern, and as the in-vitro replacement for the rabbit pyrogen test.
Which samples need endotoxin testing?
Raw materials, water for injection, in-process samples and the finished product of injectable drugs, and implantable medical devices.
What is test interference?
Substances in the sample can inhibit or enhance the endotoxin reaction. Each product is tested for interference and diluted to a validated level that removes it, within the maximum valid dilution.
Does Arab Lab supply bioprocessing media?
Yes. Lonza bioprocessing media for protein production and for cell and gene therapy are available through Arab Lab.
From the blog
Endotoxin Testing in Saudi Arabia: LAL, Recombinant Factor C and MAT Explained
LAL, recombinant Factor C and the monocyte activation test compared for endotoxin and pyrogen testing in Saudi pharmaceutical and device QC.
Read articleRegistering Pharmaceutical and Laboratory Products in the UAE, Saudi Arabia and Egypt: A Pharmaceutical Regulatory Consultant's Overview
An overview of registration for medicines, devices and lab products in the UAE, Saudi Arabia (SFDA) and Egypt (EDA), and when to use a consultant.
Read articleRelated solutions
Promicol · Tailin
Rapid Sterility & Microbial Testing
Cut sterility-test turnaround from the conventional 14 days to around 2, and test in a closed system designed to minimise false positive and false negative results.
ExploreParker
Process Filtration & Single-Use Systems
Liquid and gas filtration from clarification through bioburden reduction to sterile filtration and mycoplasma removal, and automated single-use bioprocessing.
ExploreEppendorf
Liquid Handling & Bioprocess Equipment
Instruments, consumables and accessories for cell, molecular and microbiology labs, with bioprocess hardware and software from R&D to production.
ExplorePMM
Culture Media
Pharmaceutical-grade microbiology media for environmental monitoring and sterility testing.
ExploreCPC Biotech
Enzymatic QC Reagents
Analytical enzymes and ready-to-use microbiological soils for pharmaceutical, clinical chemistry and food & beverage quality control.
ExploreTalk to a specialist.
Tell us what the lab needs to measure, make or release. We route every request to the right Arab Lab department.