What is pyrogen?

Pyrogens consist of a chemically heterogeneous group of compounds (caused by bacteria, viruses, fungi, or the material itself) that cause an increase in temperature (fiery reaction) in a human or animal.

Progenicity tests can be done with 4 different methods.

PYROGEN TEST 1; Limulus Amebocyte Lysate (LAL) Test: The basis of the test is based on the coagulation reaction of hemolymph obtained from horseshoe crab. There are 3 methods: gel-clot, chromogenic, turbidimetric.
PYROGEN TEST 2; Recombinant Factor C (rFC) Test: A non-animal mimic of LAL, rFC is a genetically engineered protein that is activated by endotoxins to produce a measurable fluorescent end product.
PYROGEN TEST 3; Rabbit Pyrogen Test (RPT): It is based on observing the possible temperature rise of 3 rabbits by intravenous injection of a test solution to each rabbit.
PYROGEN TEST 4; Monocyte Activation Assay (MAT): Sample incubated in human monocytes that produce cytokines/interleukins (IL) if pyrogens are detected in an immunoassay (ELISA).

Important Note: The European Pharmacopoeia (EP) has committed to a complete phase-out of all Rabbit Pyrogen tests by 2026. (EP 2.6.30)