In pharmaceutical and biomedical manufacturing, parenteral products must undergo Bacterial Endotoxins Testing (BET) to meet appropriate safety standards before they are released to the market. Since the gel clot Limulus Amebocyte Lysate (LAL) assay was first developed for BET, other more advanced variations of the LAL assay have emerged. These assays can not only determine the presence/absence of endotoxin in a sample, but also reveal how much endotoxin is present. This quantitative data facilitates compliance to quality control (QC) testing and data integrity standards for a wide range of applications.
There are three main types of quantitative LAL tests that are widely used for BET: chromogenic, turbidimetric and recombinant Factor C (rFC) assays. Here we focus specifically on chromogenic LAL assays and describe the two main approaches: endpoint and kinetic.
Lonza was the first commercial supplier to actually develop a chromogenic LAL assay, the endpoint QCL-1000TM Assay. From this assay evolved the most versatile chromogenic LAL assay,the Kinetic-QCLTM Kinetic Chromogenic LAL Assay. Below we outline the methods and key benefits and applications of each of these chromogenic LAL assays, which can help you choose which one best suits your needs.
When using these chromogenic LAL assays for bacterial endotoxin QC testing, our fully integrated WinKQCLTM 5 Software, which has been specially designed to support BET, can ensure the reliability and efficiency of your experiments, including automating data collection, management and reporting processes