C&EN on horseshoe crab blood testing

In the latest issue of C&EN, this fascinating feature by Laurel Oldach:

At a recent meeting of the Parenteral Drug Association, where industry microbiologists discussed ways to make drugs without a trace of unwanted biological material, photos of horseshoe crabs danced across a screen between sessions. The sediment-snuffling arthropod with a dozen legs and a shell like a helmet may seem like an unlikely pairing with the sleek, highly engineered robotics of a pharmaceutical production line. But estuaries teeming with life and clean rooms where it should be all but absent are linked by their dependence on this animal.

That is poised to change. In November, US regulators will formally announce their acceptance of alternatives to a key test that ensures drug products are not contaminated. The new tests will use proteins produced in bioreactors rather than in wild horseshoe crabs.

The change was hard fought. Arguments played out in the technical literature and in expert committee meetings. The stakes included hundreds of millions of dollars in annual sales for the company with the most to lose from a switch and the professional reputations of a group of industry insiders who were fired from their volunteer jobs. Now it appears that the tide may be turning on endotoxin tests made from horseshoe crab blood—but it hasn’t gone out just yet.

This piece is pretty long and detailed, but it is definitely worth it, as it explains the rather labyrinthine process of changing USP standards, and how it is its own bureaucratic battlefield. Read the whole thing.