A horseshoe crab Factor C protein having activity of Factor C, wherein the horseshoe crab is selected from Tachypleus tridentatus, Limulus polyphemus, and Carcinoscorpius rotundicauda, and wherein the horseshoe crab Factor C protein is produced through being recombinantly expressed from a Chinese Hamster Ovary (CHO) DG44 cell or HEK cell.

A horseshoe crab Factor C protein having activity of Factor C, wherein the horseshoe crab is selected from Tachypleus tridentatus, Limulus polyphemus, and Carcinoscorpius rotundicauda, and wherein the horseshoe crab Factor C protein is produced through being recombinantly expressed from a Chinese Hamster Ovary (CHO) DG44 cell or HEK cell.

A test device includes a specimen having a circular cross section that accommodates a test target, a specimen holding part that holds a plurality of the specimens in a row, light emitting elements in which light is incident on two adjacent specimens among the plurality of specimens, a first light guide path 46 that guides light emitted by the light emitting elements, and a second light guide path that is formed to have a smaller diameter than a diameter of the first light guide path and that guides the light emitted by the light emitting elements from the first light guide path to the specimen.

The invention relates to a method for preparation of a sample (10) of a formulation (11) for subsequent endotoxin determination, the formulation (11) suspected of comprising an endotoxin, the formulation (11) preferentially being a pharmaceutical formulation. The method comprises the following steps: application of the sample (10) to an endotoxin-free centrifugation column (2) containing a size exclusion chromatography matrix (5) that has been equilibrated with a suitable equilibration buffer (6) and elution of a flow through (15) of the sample by centrifugation, which flow through (15) can then be used for endotoxin determination. The equilibration buffer (6) is selected according to a subsequently used method of endotoxin determination, the equilibration buffer (6) only containing components not interfering with subsequently used method of endotoxin determination. Furthermore, the invention relates to a kit (20) for preparation of a sample (10).

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-flee aqueous solution, and iv) determining bacterial endotoxin in the sample using a bacterial endotoxin test, particularly the Limulus amoebocyte lysate assay.

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-flee aqueous solution, and iv) determining bacterial endotoxin in the sample using a bacterial endotoxin test, particularly the Limulus amoebocyte lysate assay.

Exemplified methods and systems facilitate presentation of data derived from measurements of endotoxins in fluid samples. In particular, the exemplified methods and systems facilitate presentation of such measurements in a graphical user interface and/or in a report for endotoxin concentrations in a fluid sample. The presentation facilitates a unified and intuitive graphic visualization that are presented within a single interactive interface and/or report.

Exemplified methods and systems facilitate presentation of data derived from measurements of endotoxins in fluid samples. In particular, the exemplified methods and systems facilitate presentation of such measurements in a graphical user interface and/or in a report for endotoxin concentrations in a fluid sample. The presentation facilitates a unified and intuitive graphic visualization that are presented within a single interactive interface and/or report.

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.

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.