Endotoxins, as cell wall components of Gram-negative bacteria, can cause an inflammatory response when released into the human blood stream, leading to serious diseases such as sepsis. Therefore, the control of endotoxin contamination within pharmaceutical formulations is of paramount importance. Low endotoxin recovery (LER) was first reported in 2013 and is a phenomenon occurring in protein formulations characterized by the efficient masking of lipopolysaccharides (LPS/endotoxin), leading to an underestimation of endotoxin observations.
It is specifically defined as the inability to recover more than 50% of the activity over time when endotoxin is added to an undiluted product. To ensure safety and efficacy, regulatory authorities require hold-time studies for endotoxins in addition to pharmacopeial requirements. Numerous studies have shown that buffers containing citrate or phosphate in combination with surfactants such as polysorbates may cause LER. The effect depends largely on storage temperature, duration of storage, and other relevant factors.
To better study LER, Creative BioMart's endotoxin experts have assembled a comprehensive and powerful technology platform to provide customers with detailed project plans, reports, consulting, and risk analysis for high-quality hold-time studies. The service is tailored according to the nature of the formulation, manufacturing process and storage conditions provided by the customer. Endotoxin was added to the samples and incubated at different temperatures for 7 days. If LER was present, the endotoxin concentration would decrease with time and temperature. The entire experiment was performed according to USP endotoxin standard. In addition to this, we also offer endotoxin demasking agents. After more than ten years of research and technological upgrading, we have become experts in LER research, and our experienced team is the guarantee of our quality service.
As a leading expert in endotoxin research, Creative BioMart has the solid expertise and scientific background to provide strong technical support to researchers around the world. Low endotoxin recovery has a great impact on endotoxin detection. In order to improve the accuracy of detection and eliminate LER interference, Creative BioMart provides you with efficient hold-time study services. If you are interested in our services, please contact us for more details.
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