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.
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
Lonza and the PyroGene™
rFC Assay are leading the way through the evolution of endotoxin
Hot off the wire...
Pharmacopeia adopts new chapter that supports use of PyroGene™ recombinant
Factor C method for endotoxin detection
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 will become effective on 1st July 2016 in
the 37 European signatory States and will be published in Supplement 8.8.
EDQM (European Directorate for the Quality of Medicines
and HealthCare) is the second regulatory authority to include specific
reference to the use of alternative methods, like the PyroGene recombinant
Factor C assay, in its pharmacopoeia.
FDA mentioned the use of rFC as an alternative in its 2012 Q&A
Guidance document on BET testing.
“One positive aspect is that now the FDA and
EDQM are aligned in their view of alternative test methods, such as recombinant
Factor C assays (PyroGene™) for product release, when properly validated. Therefore, customers should feel comfortable
using PyroGene™ for final product release, and in regulatory submissions”,
states Allen Burgenson, Manager of Regulatory Affairs.
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.
Click here for more information about the regulatory status of the PyroGene™ Recombinant Factor C Assay.