Application of Recombinant Factor C Reagent for the Detection of Bacterial Endotoxins in Pharmaceutical Products

  title={Application of Recombinant Factor C Reagent for the Detection of Bacterial Endotoxins in Pharmaceutical Products},
  author={Jay S. Bolden and Kelly R. Smith},
  journal={PDA Journal of Pharmaceutical Science and Technology},
  pages={405 - 412}
Recombinant Factor C (rFC) is non-animal-derived reagent used to detect bacterial endotoxins in pharmaceutical products. Despite the fact that the reagent was first commercially available nearly 15 years ago, the broad use of rFC in pharmaceutical industry has long been lagging, presumably due to historical single-source supplier concerns and the lack of inclusion in worldwide pharmacopeias. Commercial rFC reagents are now available from multiple manufacturers, thus single sourcing is no longer… Expand
Application of a recombinant three-factor chromogenic reagent, PyroSmart, for bacterial endotoxins test filed in the Pharmacopeias.
The present study suggests that the recombinant reagent, PyroSmart, provide a good alternative to the LAL reagents with better lot-to-lot variation. Expand
Evaluation of Limulus Amebocyte Lysate and Recombinant Endotoxin Alternative Assays for an Assessment of Endotoxin Detection Specificity.
  • J. Dubczak, N. Reid, M. Tsuchiya
  • Medicine
  • European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences
  • 2021
This study compares the official and harmonized BET test from two Limulus Amebocyte Lysate suppliers to three commercially available recombinant Factor C (rFC) reagents that contain only one of the three enzymes in the horseshoe crab clotting cascade, and includes a recombinant reagent that has been developed to include all three of the enzymes involved in the LAL coagulation cascade, occurring in the presence of endotoxins. Expand
Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review
Comparative testing of samples with both the LAL and recombinant reagents has shown a high degree of correlation, suggesting that use of rFC is comparable to the more traditional LAL tests and may be technologically superior, and that the recombinant technologies are comparable in protecting patient safety. Expand
Recombinant Factor C
  • Jay S. Bolden
  • Biology
  • Endotoxin Detection and Control in Pharma, Limulus, and Mammalian Systems
  • 2019
The use of rFC for the detection of bacterial endotoxins was successfully validated for use with multiple pharmaceutical products and for horseshoe crab conservation and for other species that depend on the horseshOE crab, including the threatened Red Knot shorebird. Expand
Comparison of Limulus Amoebocyte Lysate and Recombinant Factor C Assays for Endotoxin Detection in Four Human Vaccines with Complex Matrices
Endotoxins, heat-stable lipopolysaccharides from Gram-negative bacteria, are potential contaminants that can be introduced during manufacturing of pharmaceutical products, including vaccines.Expand
Comparison of bacterial endotoxin testing methods in purified pharmaceutical water matrices.
The results demonstrated that the two most appropriate methods for rapid endotoxin detection in water are the current assay, K-QCL, and the rFC-based assay, ENDOZYME II GO. Expand
Comparison of LAL and rFC Assays—Participation in a Proficiency Test Program between 2014 and 2019
Comparative endotoxin testing was conducted with one kinetic chromogenic LAL assay and two rFC-based assays, and results met acceptance criteria defined by compendial bacterial endotoxinTesting. Expand
Sensitive and flexible bacterial endotoxin testing with the EndoZyme ® II Recombinant Factor C Assay using the Synergy TM HTX Microplate Reader
EndoZyme II is a bacterial endotoxin test for pharmaceuticals and medical devices as well as their in-process intermediates and raw materials. The assay relies on recombinant horseshoe crab Factor CExpand
The Limulus Amebocyte Lysate (LAL) test is widely used for detection of endotoxin that is one of the most potent pyrogen. The LAL test is an application of the blood coagulation system that has beenExpand
Bacterial Endotoxin Testing—Fast Endotoxin Masking Kinetics in the Presence of Lauryldimethylamine Oxide
A novel one-step mechanism for LDAO-induced endotoxin masking is proposed, which combines the disturbance of the salt bridges and hydrophobic interactions with LPS in one molecule. Expand


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