To provide a method for producing a horseshoe crab recombinant Factor C. The horseshoe crab recombinant Factor C is produced through expression thereof by use of mammalian cells such as CHO DG44 and HEK293 as host cells.

Methods for determining the endotoxin content of an aluminum salt preparation for use in medicine are provided. The methods include mixing the aluminum salt with a desorption buffer and separating the aluminum salt from the endotoxin.

Methods for determining the endotoxin content of an aluminum salt preparation for use in medicine are provided. The methods include mixing the aluminum salt with a desorption buffer and separating the aluminum salt from the endotoxin.

Methods for detecting and quantifying toxins present in the oral cavity. The methods may include providing a biological sample, providing reporter cells expressing one or more Toll like receptors, exposing the cells to the biological sample, measuring the EC50 value of the lipopolysaccharide on activation of a Toll like receptor, quantification of the lipopolysaccharide in the biological sample.

Methods for detecting and quantifying toxins present in the oral cavity. The methods may include providing a biological sample, providing reporter cells expressing one or more Toll like receptors, exposing the cells to the biological sample, measuring the EC50 value of the lipopolysaccharide on activation of a Toll like receptor, quantification of the lipopolysaccharide in the biological sample.

The present invention is related to compositions comprising clarified limulus amebocyte lysate (LAL), wherein the LAL is substantially free of coagulogen and methods of making such compositions. The invention further relates to a method of detecting an endotoxin in a sample using a chromogenic assay, the method comprising: (a) contacting the sample with a reagent comprising clarified LAL and a chromogenic substrate; and (b) measuring a chromogenic effect resulting from a change in the chromogenic substrate in the presence of endotoxin in the sample, wherein the LAL is substantially free of coagulogen. The invention also relates to kits comprising clarified LAL substantially free of coagulogen, and methods of making such.

Herein is reported a method for determining bacterial endotoxin at low concentrations in a sample of an antibody (that has been produced using bacterial cells) comprising the following steps in the following order: i) adding magnesium ions to the sample, ii) diluting the sample, iii) dialyzing the sample having a pH-value of 5.7-8.0 against an endotoxin-free aqueous solution, and iv) determining bacterial endotoxin in the sample using a bacterial endotoxin test, particularly the limulus amoebocyte lysate as say.

Herein is reported a method for determining bacterial endotoxin at low concentrations in a sample of an antibody (that has been produced using bacterial cells) comprising the following steps in the following order: i) adding magnesium ions to the sample, ii) diluting the sample, iii) dialyzing the sample having a pH-value of 5.7-8.0 against an endotoxin-free aqueous solution, and iv) determining bacterial endotoxin in the sample using a bacterial endotoxin test, particularly the limulus amoebocyte lysate as say.

Methods and systems for measuring the concentration of LAL-reactive substances in fluid samples is provided. They include contacting an aqueous sample with a detection reagent to form a prepared sample. A physical property of the prepared sample may be measured to obtain at least one sample measurement characteristic of the prepared sample. Curve fitting may then be used to forecast a concentration of the LAL-reactive substance the aqueous sample will have at a specified time in the future based on the sample measurement and a correlation developed between at least one standard measurement of a physical quality of a solution with a known concentration of a LAL-reactive substance therein. The quality of the sample measurement may be validated using historical data and/or the standard measurement.

Methods and systems for measuring the concentration of LAL-reactive substances in fluid samples is provided. They include contacting an aqueous sample with a detection reagent to form a prepared sample. A physical property of the prepared sample may be measured to obtain at least one sample measurement characteristic of the prepared sample. Curve fitting may then be used to forecast a concentration of the LAL-reactive substance the aqueous sample will have at a specified time in the future based on the sample measurement and a correlation developed between at least one standard measurement of a physical quality of a solution with a known concentration of a LAL-reactive substance therein. The quality of the sample measurement may be validated using historical data and/or the standard measurement.