Endotoxin testing and the horseshoe crab: what’s next?

Published: 19-Apr-2016

The development of alternative endotoxin tests such as recombinant factor C assays can provide a long-term, effective alternative to sourcing lysates from horseshoe crabs. Lakiya Wimbish, Product Manager, Lonza, reports on this and other endotoxin testing news

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Endotoxin testing is an essential part of the manufacturing process for parenteral products. Without this critical step, patient health and safety would be compromised.

Endotoxins are derivatives of bacterial cell membranes that can induce unfavourable symptoms in patients, including fever, when not passed through the digestive system. Current endotoxin tests employ assays using lysate of one of two horseshoe crab genera: Limulus or Tachypleus. Limulus amoebocyte lysate (LAL) and Tachypleus amoebocyte lysate (TAL) coagulate when in contact with endotoxins and this highly sensitive reaction forms the basis for the assays. While this test currently remains a key resource for the pharmaceutical industry, challenges are emerging, and these challenges are being met by innovative solutions that are pushing the endotoxin testing community into new directions.

As the global population grows and developing nations become wealthier, healthcare demands increase, including the demand for parenteral medicines. These medicines all need to be tested for endotoxins and will therefore enhance the demand for LAL and TAL, the former being the sole lysate used in Western nations and the latter being used predominantly in Asia. This will place great pressure on the source of these lysates: the blue blood of horseshoe crabs.

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