Lonza Not 'Shellfish' When it Comes to Endotoxin QC Testing

By Dan Stanton

- Last updated on GMT

Lonza Not 'Shellfish' When it Comes to Endotoxin QC Testing
Lonza says it is raising awareness of the role horseshoe crabs play in QC endotoxin detection tests, and its PyroGene Assay can provide a sustainable alternative.

For every new subscriber of its e-newsletter​ on endotoxin and rapid mycoplasma detection, Lonza has pledged to donate $1 to the Ecological Research & Development Group (ERDG), a charity dedicated to protecting the world’s horseshoe crabs – a species essential in providing the raw material in Limulus Ameboctye Lysate (LAL) Endotoxin Detection tests.

“It is a gesture which we hope will raise awareness in support of this amazing animal and its unique contribution to human and animal health,”​ said spokesperson Jody Baller, who told in-Pharmatechnologist.com about the significance of the horseshoe crab in contributing to the safety of drugs and medical devices.

The LAL Quality Control (QC) test was developed to ensure intravenous drugs and medical devices are safe from endotoxin contamination by testing them with raw, in-process and final release materials.

Baller added “LAL is the current ‘gold standard’ for endotoxin testing and is required by law around the world” ​for all injectables, vaccines, chemotherapies and intravenous saline solutions before they can be released for consumer use.

The importance of horseshoe crabs in detecting the presence of Gram-negative bacteria in pharmaceutical products was first discovered in 1964. The crab’s own natural defense mechanism against the bacteria is to form a blood clot that provides wound control by preventing bleeding and forming a physical barrier against additional bacterial entry and infection, a mechanism that has since been taken up by the pharmaceutical industry for QC testing.

In order to manufacture LAL, the industry collects a portion of blood from horseshoe crabs and releases them back alive. However, according to the ERDG​, up to 15 per cent of crabs do not survive accounting for the death of 20,000 to 37,500 horseshoe crabs per year.

Lonza’s latest commitment to the sustainability of the species comes as environmental changes and the use in fishing threaten the species further.

Lonza's Alternative

In 2009 the US Food and Drug Administration (FDA) approved the application for Lonza’s PyroGene Assay - an alternative QC test for endotoxins which does not use horseshoe crab blood as a raw material – and last year approved it as an alternative to LAL, issuing a specific guidance document​ on its use in the industry.

The PyroGene system contains a recombinant form of Factor C, (rFC), an endotoxin-sensitive protein that initiates the traditional LAL clotting mechanism. According to Baller, Lonza is one of only a few companies to have developed an alternative test and “the rFC technology eliminates false-positive glucan reactions.”​ Furthermore, because it is not a biologic, it “offers predictable and reliable lot-to-lot performance.”

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