Surveys to vaccine and pharmaceutical regulators and manufacturers on endotoxin testing methods

Endotoxin testing is essential for ensuring the safety of injectable pharmaceutical products by detecting potentially harmful bacterial toxins.

Traditional gold standard method, the Limulus Amebocyte Lysate (LAL) test, utilizes horseshoe crab blood for endotoxin detection. However, use of horseshoe crab blood led to the decline in horseshoe crab population. It now poses a significant threat to the sustainability of LAL test, impacting the medical field by potentially jeopardizing the safety of pharmaceutical products and posing a significant threat to public health.

Advancements in technology have introduced alternatives, notably the recombinant Factor C (rFC) assay, which offers a sustainable and ethical alternative by eliminating the need for horseshoe crab blood.

This survey aims to review current endotoxin testing methods and assess the potential for the rFC method to be adopted by manufacturers in Low- and Middle-Income Countries (LMICs).

By evaluating the benefits and challenges of rFC technology, this survey seeks to provide valuable insights into how LMIC manufacturers, regulators and stakeholders might navigate the transition to this innovative method, enhancing their testing capabilities while addressing global sustainability and ethical considerations.