FDA approves the recombinant Horseshoe Crab Factor C (rFC) test for bacterial endotoxin control of Galcanezumab


Eli Lilly and Company

Now official:

FDA has approved rFC for final product release of Galcanezumab.

As anticipated by Jay Bolden in the Zhang and Cramer articles from May 2018 (links below), Eli Lilly has now received U.S. FDA approval for Emgality™ (galcanezumab-gnlm), including the use of recombinant Horseshoe Crab Factor C (rFC) test for bacterial endotoxin.

The rFC test replaces the Limulus amebocyte lysate (LAL), thereby eliminating the use of a reagent extracted from live animals, and has been validated according to USP chapters <1225> and <85>, fulfilling all required criteria.