LAL and Bacterial Endotoxins Testing
The LAL (limulus amebocyte lysate) Assay is an in vitro assay used to detect the presence and concentration of bacterial endotoxins in drugs and biological products, and is an important part of pharmaceutical microbiology. Endotoxins, which are a type of pyrogen, are lipopolysaccharides present in the cell walls of gram-negative bacteria. Pyrogens as a class are fever-inducing substances that can be harmful or even fatal if administered to humans above certain concentrations.
The endotoxin testing lab at Pacific BioLabs performs the Kinetic Chromogenic LAL Assay, a sensitive colorimetric assay that can detect endotoxin levels in solutions at concentrations as low as 0.005EU/mL.
In addition to pharmaceutical preparations, water can also be a source of pyrogens. Therefore, it may be important to perform endotoxin testing to routinely monitor water systems.
Rabbit Pyrogen Test
The Rabbit Pyrogen Test in an in vivo test to detect pyrogens qualitatively. Rabbits have a similar pyrogen tolerance to humans, so by observing a change in body temperature in rabbits it is possible to make a determination of the presence of pyrogens. This method can detect non-bacterial endotoxin pyrogens as well as bacterial endotoxins.
Available Endotoxin and Pyrogen Testing Services
- Kinetic Chromogenic LAL Method (for bacterial endotoxins) – in vitro
- (10mL sample size required for water; call PBL for containers if needed.)
- USP / JP / EP / ISO (material mediated) Rabbit Pyrogens Test – in vivo
Read More About LAL Endotoxin and Rabbit Pyrogen Testing
- PBL’s Learning Center – Compendial Microbiology
- PBL’s Learning Center – Pharmaceutical CMC Expectations
- PBL’s Learning Center – CMC Activities for Biologics and Monoclonal Antibodies