The United States Pharmacopeia (USP), via their official journal, Pharmacopeial Forum (PF), has announced plans to develop a draft chapter Bacterial Endotoxins Test, which will include the addition of recombinant Factor C assays.

Eur.) Commission announced that it expects to include Chapter 2.6.32, Test for bacterial endotoxins using recombinant Factor C, as one of the 4 general chapters to be adopted in its next version, effective January 1, 2021.

In Dec 2019, The 165th European Pharmacopeia (Ph.

USP 28-NF 33 General Notices states that alternative testing methods, such as recombinant Factor C (rFC) can be used if the alternative method provides advantages in accuracy, sensitivity, precision, selectivity, or adaptation to automation. Read Press ReleaseĪccepted by several global regulatory authorities including the FDA and the European Pharmacopeia, the recombinant Factor C method is a recognized, comparable endotoxin detection method to LAL-based assays. The graph on the left illustrates the enzymatic cascade of the recombinant Factor C assay compared to the enzymatic activation pathway of traditional LAL assays, like the kinetic chromogenic and kinetic turbidimetric assays. In the presence of endotoxin, activated rFC will cleave the fluorogenic substrate, causing the solution to fluoresce. The PyroGene TM rFC method is a quantitative assay that is run on a 96-well plate incubated in a microplate reader at 37☌ that measures fluorescence with excitation/emission wavelengths at 380/440 nm.

Due to the high dynamic range of the fluorescent signal, PyroGene TM rFC delivers a quantitative range of 5.0 EU/ml – 0.005 EU/ml in a single step, with better resolution than conventional kinetic LAL assays. In the PyroGene TM rFC assay, activated Factor C directly cleaves a fluorogenic substrate, producing a signal that is read using a standard fluorescent plate reader. Learn more about our rFC assay by visiting the PyroGene TM Recombinant Factor C Assay product page where you can find comprehensive details, including a product overview, educational materials, and scientific data about the effectiveness of rFC as a BET assay. The recombinant Factor C method works through a single enzymatic step compared to the multiple step enzymatic process necessary for LAL assays. Based on the activation of a recombinant form of Factor C, the first component in the horseshoe crab clotting cascade activated by the presence of endotoxin, the recombinant Factor C assay offers the same reliability as an LAL method – without the use of animal resources. The PyroGene TM Recombinant Factor C Assay is the evolution of endotoxin detection testing.

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