Recombinant Factor C

Recombinant proteins are the fundamental product of modern biotechnology. LAL is the purified protein extracted from horseshoe crabs used to test pharmaceutical products for bacterial endotoxins; the use of LAL has ensured the safe supply of medicine for over 30 years. A synthetic recombinant protein Factor C (rFC), the first protein in the LAL cascade, has been commercially available for 15 years, however market uptake has been limited for various reasons. With respect to horseshoe crab conservation and for other species that depend on the horseshoe crab, including the threatened Red Knot shorebird, the use of rFC for the detection of bacterial endotoxins was successfully validated for use with multiple pharmaceutical products. A validation strategy is described herein and an example validation protocol is provided for the convenience of the end-user.