Endotoxins are lipopolysaccharides (LPS) from the cell wall of gram-negative bacteria that are normally released after cell death or lysis. Lipopolysaccharides (LPS) are compounds consisting of fat (lipo) and sugar (polysaccharide) components.
Endotoxins have a significant impact on bioproduction processes, as they can negatively affect upstream fermentation as well as downstream fill and finish. For example, endotoxins can massively affect tissue cultures by interfering cell proliferation and cell function.
In parenteral drug formulations, they are undesirable because endotoxins can cause mild to severe immune reactions, including fever and inflammation, and even death. Therefore, for a number of highly sensitive applications, it is of utmost importance to use Mineral Salts with a low-endotoxin content.
Our low-endotoxin grades are produced in GMP-certified production facilities designed specifically for this purpose. Thus, our Mineral Salts Low in Endotoxins are produced according to their sensitive applications under the strictest conditions including low endotoxin process water.
To meet the highest standards and ensure consistent high quality, validated chromogenic-kinetic Limulus Amebocyte Lysate (LAL) tests are used to quantify the endotoxin content of our products.
Additional products can be developed or lower endotoxin limits (LAL) can be met upon customer request.