The PyroGene™ recombinant Factor C (rFC)  Assay is an animal-free alternative to LAL that has been accepted by the FDA as an alternative method.       

The PyroGene™ rFC Assay does not use horseshoe crab blood as the raw material, therefore, there is less dependence on the animal, which results in less animal utilization. 

  

 

Comparable Endotoxin Detection Method to LAL-based Assays  

Accepted by the FDA, European Pharmacopeia and other leading regulatory authorities, the recombinant Factor C method is a recognized, comparable endotoxin detection method to LAL-based assays.  Based         on the activation of a recombinant form of Factor C, the first component in the horseshoe crab clotting cascade, the PyroGene™ rFC Assay offers the same reliability as an LAL method – without the use of animal resources. 


White Paper: PyroGene™ Recombinant Factor C Assay

Endotoxin Testing: It’s Time to Embrace the Alternative

                                                                                                              

Topics include:

  • The growing demand of a natural resource
  • Benefits of the synthetic version of Factor C     
  • How to validate PyroGene™ rFC Assay  
   

download-pyrogene-white-paper-pdf     

Download White Paper

technician adding working reagent into reagent reservoir                                                   

Watch How to Perform the PyroGene™  recombinant Factor C Assay

Duration: 5:55

            

 Advantages of the PyroGene™ 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 PyroGene™ rFC Assay as a final release test Comprehensive     FDA Master File

           

 

Request Validation Protocol

 

 

 

The Case for Recombinant Factor C: Primed for the Big Time

Lonza’s Dr. Elena Gustchina will co-present with Jay Bolden, Eli Lilly at the PDA Europe Pharmaceutical Microbiology’s Challenge Summit, “The Case for Recombinant Factor C – Primed for the Big Time,” 14 Feb 2017, Porto Portugal.  Elena will also be showcasing a poster entitled, “Pushing the Limits of the PyroGene™ recombinant Factor C Assay,” to demonstrate recent improvements to the PyroGene™ Assay platform.  

European Pharmacopeia Chapter 5.1.10 Now Effective!

The proposed revision of Ph. Eur. chapter 5.1.10, which included language to support the use of recombinant Factor C as alternative test method to the LAL test, was adopted by the European Pharmacopoeia Commission during its 152nd session in Strasbourg on 16-17 June 2015.  The revised chapter 5.1.10 became effective on 1st July 2016 in the 37 European signatory States and will be published in Supplement 8.8.

The rFC assay will still be considered an “Alternative Test”, subject to the validation requirements of USP <1225> or ICH Q2B.  Regulatory authorities will accept the test results of the rFC assay, but a validation study must be performed, per product.  Validation studies are used to compare the alternative and compendial method, and verify the equivalence between the two methods of the assay.  Post-validation, it is necessary to follow up with the appropriate regulatory filing for the drug product or device.

Learn more about the regulatory status of the PyroGene™ Recombinant Factor C Assay.