Four main types of bacterial endotoxin testing methods have been developed based on the principles of LAL testing. These all have important applications in quality control (QC) testing during the manufacture of parenteral medicines and injectable devices.
Qualitative: Simple Yes/No Answer.
- Gel Clot LAL Assays:
Simple LAL test. Visual inspection of gel formation; does not require incubating reader and software.
Quantitative: Reveals not only the presence of endotoxin, but also the amount present. Results calculated from a standard curve.
- Chromogenic LAL Assay:
Endpoint and kinetic. Kinetic or endpoint measurement of color development allow a quantitative readout of the endotoxin concentration in the sample measured. - Turbidimetric LAL Assay:
Kinetic measurement of turbidity development is a cost-effective way of BET testing water samples or large volume parenterals. - Recombinant Factor C:
Non-animal alternative to LAL based on the recombinantly produced form of Factor C, the first component in the horseshoe crab clotting cascade. Does not rely on horseshoe crab blood as the source testing reagent.
Note that any of Lonza’s quantitative testing products can be automated for higher throughput testing needs. Learn more about endotoxin automation.
To learn more about the different endotoxin testing methodologies, access our On-demand Webinar, "Endotoxin Detection: Which Method Is Best for Me?" Log in or create a Lonza website account to view.