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The pharmaceutical industry must embrace synthetic alternatives to horseshoe-crab blood

Niles, Lawrence
4–5 minutes
  • CORRESPONDENCE
  1. Tim Cernak
    1. University of Michigan, Ann Arbor, Michigan, USA.

  2. Lawrence Niles
    1. Wildlife Restoration Partnerships, Greenwich, New Jersey, USA.

The inclusion in the United States Pharmacopeia (USP) of a chapter on endotoxin testing (chapter 86), is a pivotal moment in the biomedical industry’s relationship with nature. Chapter 86 in this summary of drug information allows pharmaceutical companies to fully adopt the recombinant Factor C (rFC) assay, a synthetic alternative to the Limulus amebocyte lysate (LAL) test, which is derived from horseshoe-crab blood.

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Nature 633 , 286 (2024)

doi: https://doi.org/10.1038/d41586-024-02893-6

Competing Interests

T.C.’s lab has been supported by MilliporeSigma, Johnson & Johnson, Relay Therapeutics, Merck Sharp & Dohme, SPT Labtech, National Defense Medical Center, Shanghai University of Traditional Chinese Medicine, Ministry of Education Taiwan, and Entos, Inc.. T.C. has consulted for the University of Dundee Drug Discovery Unit, Scorpion Therapeutics, Relay Therapeutics, Amgen, Genentech, Janssen, Pfizer, Vertex, MilliporeSigma, the US Food & Drug Administration, Gilead, AbbVie, Corteva, Syngenta, Firmenich, Biogen, Bayer, UCB Biopharma, National Taiwan University, AstraZeneca, Grunenthal, and Iambic Therapeutics (previously known as Entos, Inc.). He holds equity in Scorpion Therapeutics and is a co-founder of and equity holder in Iambic Therapeutics.

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