Current horseshoe crab harvesting practices cannot support global demand for TAL/LAL: The pharmaceutical and medical device industries' role in the sustainability of horseshoe crabs

Abstract

Globally, injectable pharmaceuticals and parenterals, implantable medical devices and similar therapeutic products are safety tested for endotoxin contamination using indicator reagents derived from the blood of horseshoe crabs. Tachypleus and Limulus Amoebocyte Lysate (TAL and LAL, respectively) are used in quality control laboratories for testing of raw materials, intermediates and final products to protect public health. As the demand for human and animal drugs and devices increases, so does the demand for TAL and LAL. In the United States, the harvesting of horseshoe crabs (Limulus polyphemus) is regulated and monitored. Harvesting limits have been exceeded in recent years and may lead to enforcement of harvesting limits to the American LAL industry. Throughout most of Asia, the harvesting of horseshoe crabs is poorly regulated and unmonitored. All indicators point to a declining population. If the Tachypleus population cannot support TAL production for the Asia and Pacifi c pharmaceutical and medical device industries, companies will entirely depend on LAL for testing. The already limited LAL supply is not suffi cient to support this increased global demand and will likely result in increased cost and constrain the availability of pharmaceutical and medical device products. As consumers of horseshoe crab-based products, the pharmaceutical and medical device industries can act to help protect horseshoe crab species and, in turn, protect the long-term availability of endotoxin testing products. Global supply chain initiatives that integrate social and environmental considerations into the qualifi cation and choice of vendors, use of best practices for TAL and LAL production, and developing alternative testing methods will promote a more sustainable TAL/LAL industry that can include reduction of animal-based testing and global conservation of horseshoe crab species.