Endotoxin Testing

Are you concerned about the quality of your pharmaceutical products and implantable medical devices? Well, no matter how many times you have examined your products’ quality, you should also test the presence of endotoxins to ensure safety and prevent potential health risks. It is when you need PLS Analytical, well-known for quality endotoxin testing of different medical products.

Endotoxins are lipopolysaccharides (LPS) or exogenous pyrogen, generated by bacterial death or autolysis. It can cause severe immune reactions when intravenously enters the body, leading to serious bacterial infections. Thankfully, our experts at PLS Analytical can perform bacterial endotoxin testing for raw materials, medical devices, injectables, etc.

Want to undergo endotoxin microbiological testing? Contact our experts now.

Best-in-Class Endotoxin Testing Method at PLS Analytical

Usually, several methods are available for endotoxin testing in microbiology. However, the most widely used technique at PLS Analytical is the Limulus Amoebocyte Lysate (LAL) assay. The LAL assay utilizes the blood of horseshoe crabs, containing a protein called Limulus amoebocyte lysate. This protein has a unique ability to form a clot in the presence of endotoxins, indicating their presence. The LAL assay appears in various forms. These include -

Gel clot - It involves the formation of a gel clot in the presence of endotoxins.

Turbidimetric - It measures the increase in turbidity caused by the reaction between endotoxins and the LAL reagent.

Chromogenic -It uses a colorimetric reaction to detect the presence of endotoxins.

Indeed, these methods help determine the sensitivity levels and detection limits, allowing researchers to choose the most suitable option for their specific needs.

Moreover, endotoxin testing is crucial for biopharmaceuticals, cell therapy, and raw materials for ensuring safety and efficacy.

Biopharmaceuticals: With the advancements in biotechnology and genetic engineering, the scope for biopharmaceuticals has grown a lot. These are drugs or therapeutic products derived from biological sources such as living organisms, cells, or proteins. They offer effective treatments for various diseases, including cancer, autoimmune disorders, and genetic conditions. It is the reason why these require enhanced quality testing to assess the purity, potency, and absence of microbial contaminants.

Cell Therapy: Cell therapy involves the use of living cells for treating diseases or promoting tissue regeneration. It can address severe health conditions such as certain types of cancer, neurodegenerative disorders, and cardiovascular diseases. The scope for cell therapy is growing exponentially as researchers continue to explore new applications and optimize manufacturing processes. Hence, it requires endotoxin testing to ensure that cell therapy products meet stringent safety standards.

Raw Materials: Raw materials used in biopharmaceuticals or cell therapy, such as culture media, reagents, buffers, etc., are often the potential source of endotoxin contamination. By undergoing endotoxin testing in raw materials, manufacturers can identify potential sources of endotoxin, thereby avoiding them and reducing the risk.

In a nutshell, biopharmaceuticals, cell therapy, and raw materials are all interconnected fields in microbiology. Since their scope for endotoxin testing is growing at a rapid pace, we allow industries like pharmaceuticals and food production to detect the presence of these potent toxins. We follow the strict guidelines of regulatory bodies, including the FDA and USP parameters (mentioned in USP <85>, <161> and European Pharmacopoeia (EP) general chapter 2.6.14)

Want to know more? Get assistance at PLS Analytical.

Identify and Quantify Endotoxin Contamination at PLS Analytical

PLS Analytical serves several industries that deal with health-related products or devices. You can choose this bacterial endotoxin testing to reduce retest rates and improve turnaround times so that you can take the right decisions about your products’ quality. Are you interested in determining endotoxin contamination in your system? PLS Analytical is at your service. Give us a call today.

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