Horseshoe crabs’ icy-blue blood will remain the drug industry’s standard for safety tests after a powerful US group ditched a plan to give equal status to a synthetic substitute pushed by Swiss biotech Lonza and animal welfare groups.
More recently, man-made versions called recombinant Factor C (rFC) from Basel-based Lonza and others have emerged.
An industry battle has been brewing, as another testing giant, Lonza’s US-based rival Charles River Laboratories, has criticised the synthetic option on safety grounds.
Maryland-based US Pharmacopeia (USP), whose influential publications guide the drug industry, had initially proposed adding rFC to the existing chapter governing international endotoxin testing standards.
USP has now abandoned that, it announced late on Friday, opting instead to put rFC in a new stand-alone chapter. This means drug companies seeking to use it must continue to do extra validation work, to guarantee their methods of using rFC tests match those of tests made from crab blood.
The decision gives the drug industry fewer incentives to end its reliance on animal-based tests, even as companies like Lonza and France’s bioMerieux promote man-made alternatives and wildlife advocates worry about crab bleeding’s effect on the coastal ecosystem.
Maryland-based US Pharmacopeia (USP), whose influential publications guide the drug industry, had initially proposed adding rFC to the existing chapter governing international endotoxin testing standards.
USP has now abandoned that, it announced late on Friday, opting instead to put rFC in a new stand-alone chapter. This means drug companies seeking to use it must continue to do extra validation work, to guarantee their methods of using rFC tests match those of tests made from crab blood.
The decision gives the drug industry fewer incentives to end its reliance on animal-based tests, even as companies like Lonza and France’s bioMerieux promote man-made alternatives and wildlife advocates worry about crab bleeding’s effect on the coastal ecosystem.
USP told Reuters on Sunday its experts concluded there was too little practical experience with drug products tested with rFC to put the synthetic tests on equal footing with crab blood tests, which have been widely used for decades.
