Product Focus in BioPharma Asia: Hyglos Addresses the Underlying Causes of Low Endotoxin Recovery (LER)

10.01.2017

Demasking with Endo-RS® Ensures Full Recovery of Endotoxin Contaminants prior to LAL Detection

Hyglos Addresses the Underlying Causes of Low Endotoxin Recovery (LER)

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Demasking with Endo-RS® Ensures Full Recovery of Endotoxin Contaminants prior to LAL Detection

Scientists have determined that endotoxin is likely to be masked in biologics typically containing phosphate or citrate and polysorbates. In a masked state, endotoxin is not accessible for detection by conventional detection methods such as the Limulus amebocyte lysate test (LAL). This phenomenon has been denominated Low Endotoxin Recovery (LER).

In order to ensure patient safety, authorities require thorough analysis of each new drug as well as the development of suitable in vitro test methods for testing of affected products.

To meet this analytical need, the Hyglos scientists developed the Endo-RS® endotoxin recovery method. Endo-RS is a sample preparation method, which in combination with rFC or LAL renders endotoxin contaminants detectable over time. The detectability of endotoxin depends on the concentration of a number of factors typically specific to each individual biopharmaceutical product. The Endo-RS technology with its wide biochemical spectra addresses exactly this complex situation and renders endotoxin detectable again.

Hyglos Customized Services for demasking protocol development fulfills all Pharmacopoeial validation criteria and GMP requirements.

https://biopharma-asia.com/products/hyglos-addresses-underlying-causes-low-endotoxin-recovery-ler/