European agency backs synthetic crab blood for medical safety tests

The issue in question for the agency was whether recombinant factor C (rFC) can be used in the bacterial contamination tests, rather than the classic limulus amoebocyte lysate (LAL)-based methods that rely on blood from the crabs. "When used under appropriate conditions, rFC-based methods provide the same guarantee of a product's compliance with the test for bacterial endotoxins – and therefore, of its safety for use in patients – as LAL-based methods," Susanne Keitel, director of the European Directorate for the Quality of Medicines and Healthcare (EDQM), said in a statement.

Companies can use a synthetic alternative to the blood of horseshoe crabs in safety tests for medical products, a European agency has ruled, in a boost for wildlife advocates and groups such as Lonza that make it. To test for bacterial contamination in medical products, the world now relies on a single source of lysate - the blood of two species of the horseshoe crab family that are endangered.

Wildlife advocates are pushing drugmakers to switch to a synthetic alternative for the tests, including those needed before a COVID-19 vaccine can be used on humans. The issue in question for the agency was whether recombinant factor C (RFC) can be used in the bacterial contamination tests, rather than the classic Limulus amoebocyte lysate (LAL)-based methods that rely on blood from the crabs.

"When used under appropriate conditions, RFC-based methods provide the same guarantee of a product's compliance with the test for bacterial endotoxins – and therefore, of its safety for use in patients as LAL-based methods," Susanne Keitel, director of the European Directorate for the Quality of Medicines and Healthcare (EDQM), said in a statement. The agency posted https://www.edqm.eu/en/news/recombinant-factor-c-new-ph-eur-chapter-available-1-july-2020 its findings late on Wednesday under a new chapter that takes effect at the start of 2021 and applies to 39 countries signed up with European Pharmacopoeia.

"The publication of the new general chapter ... therefore marks a significant step towards alleviating the need for these animal resources," the agency said.