PyroGene™ recombinant Factor C Assay Validation Protocol
Adoption of alternative endotoxin test methods, like PyroGene™ rFC, are on the rise as recombinant methods have proven equivalency to LAL-based methods and have already been accepted by several global
regulatory authorities.
The validation required for the PyroGene™ rFC Assay is identical to what would be needed for any LAL-based method with just one extra step: "Validation of Alternative Method."
Advantages:
- Animal-free, sustainable
- Endotoxin-specific
- Reliable lot-to-lot performance
Ready to consider adopting PyroGene™ rFC in your lab? We make it easy for you.