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Pharma & Biotech

PyroGeneTM Recombinant Factor C Endpoint Fluorescent Assay

Catalog #: 50-658U

Recombinant Factor C Endpoint Fluorescent Assay for endotoxin testing up to 192 tests.

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Product Overview

The PyroGeneTM Recombinant Factor C Assay is the evolution of endotoxin detection testing. Lonza scientists have developed a recombinant form of Factor C, the first component in the horseshoe crab clotting cascade activated by endotoxin. Recombinant Factor C (rFC) is activated by endotoxin binding, and the active enzyme then cleaves a synthetic substrate, resulting in the generation of a fluorogenic compound. PyroGeneTM rFC works through a single enzymatic step compared to the multiple step enzymatic process necessary for LAL assays.

The reaction is run in a 96-well microplate and is measured at time zero and after a one-hour incubation in a fluorescent microplate reader using excitation/emission wavelengths of 380/440 nm. In the presence of endotoxin, activated rFC will cleave the fluorogenic substrate, causing the solution to fluoresce. The log net fluorescence is proportional to the log endotoxin concentration and is linear in the 0.005 - 5.0 EU/ml range. 

 

Advantages of the PyroGeneTM rFC Assay:

  • Endotoxin specific, recombinant technology eliminates false-positive glucan reactions
  • Predictable, reliable lot-to-lot assay performance
  • Sustainable resource –  no animal utilization
  • Endpoint fluorescent assay, comparable to other quantitative LAL methods
  • 510(K) submissions have been approved by the FDA using PyroGeneTM rFC Assay as a final release test
  • Comprehensive FDA Master File

The PyroGeneTM rFcAssay is equivalent to other photometric endotoxin methods that use LAL to detect endotoxins according to the parameters listed in the USP chapter<<1225>> “Validation of Compedial Procedures”. These parameters include linearity, specificity, precision, accuracy, and limit of detection.

Lonza and the PyroGeneTM rFC Assay are leading the way through the evolution of endotoxin detection. 

Benefits

  • Sensitivity range from 0.005 to 5 EU/ml
  • Higher endotoxin specificity through the elimination of false positive glucan reactions
  • Less lot-to-lot variability
  • Security of supply
  • FDA acknowledged alternative to LAL

Applications

  • In-process testing
  • Final product testing
  • Water testing
  • Testing plant-based material

Content & Storage

Content

  • 2 x 96 tests/vialrFC enzyme solution
  • 2 x 6 mL/vial fluorogenic substrate
  • 2 x 5 mL/vial rFC assay buffer
  • 2 vials endotoxin
  • 2 x 30 mL/vial LAL Reagent Water

Instructions

Safety Data Sheets (SDS)

Certificate of Analysis (CoA)

Please enter Lot Number, including all zeros, located on the product label and please take into account that it is case sensitive.

Response to Different Endotoxin Sources

Endotoxin potency of four purified lipopolysaccharide preparations as tested by multiple methods. The results of a comparison between the responses of the rFC, kinetic chromogenic LAL and kinetic turbidimetric LAL photometric methods to different sources of purified endotoxin. The data demonstrates that the rFC method can recognizes endotoxin from different source materials similar to other photometric procedures, demonstrating comparability to the LAL-based methods.

PyroGeneTM rFC Assay and Endotoxin Specificity

The PyroGeneTM rFC assay does not react with glucans, thereby reducing false-positive results. Comparison of glucan activity between kinetic chromogenic LAL and rFC. The false positive signal from the LAL assay is reduced in the presence of a glucan blocker. The rFC assay is endotoxin specific.

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