After a lengthy review, the organization that sets manufacturing standards for drug makers will keep a decades-old test — derived from horseshoe crabs — as its go-to tool for detecting contamination in medicines and vaccines, rather than recommending that drug makers switch to a synthetic alternative.

The decision centers around endotoxin tests, which are used to detect bacterial contamination in intravenous drugs and vaccines, among other products. But controversy over the ongoing supply of horseshoe crabs — whose blood is used for reagents — and a battle between two of the biggest test suppliers prompted the U.S. Pharmacopeia to review its standards.

Unlock this article by subscribing to STAT Plus and enjoy your first 30 days free!

GET STARTED

What is it?

STAT Plus is STAT's premium subscription service for in-depth biotech, pharma, policy, and life science coverage and analysis. Our award-winning team covers news on Wall Street, policy developments in Washington, early science breakthroughs and clinical trial results, and health care disruption in Silicon Valley and beyond.

What's included?

  • Daily reporting and analysis
  • The most comprehensive industry coverage from a powerhouse team of reporters
  • Subscriber-only newsletters
  • Daily newsletters to brief you on the most important industry news of the day
  • STAT+ Conversations
  • Weekly opportunities to engage with our reporters and leading industry experts in live video conversations
  • Exclusive industry events
  • Premium access to subscriber-only networking events around the country
  • The best reporters in the industry
  • The most trusted and well-connected newsroom in the health care industry
  • And much more
  • Exclusive interviews with industry leaders, profiles, and premium tools, like our CRISPR Trackr.
Sign up to receive a free weekly opinions recap from our community of experts.
Privacy Policy