bioMérieux's solutions for endotoxin detection Combine a Strong Innovative Spirit with Customer Vision

Interview with Holger Grallert, Scientific Expert at bioMérieux’s Endotoxin Center of Excellence 

Endotoxins can cause very serious side effects in patients. To ensure patient safety, endotoxin detection is a necessary prerequisite — and regulatory requirement — for all injectable drugs and implantable devices. 

Our clients manage several tests each year, sometimes even tens of thousands. Their priorities are the simplification, automation and robustness of the tests. They are exploring software that is aligned with pharmaceutical regulatory requirements and addresses data security issues. Some of their samples are very specific and need highly sophisticated solutions.  

We developed a range of products and services that provide high throughput and can handle complex samples. For example, ENDOZYME® II GO allows faster, easier tests while ENDOLISA® offers precise and robust quantification of endotoxin content in complex samples. At our Center of Excellence in Germany, there are 20 dedicated experts who are continuously improving the test systems and developing sample-specific solutions to answer our customers’ evolving needs.

The Endotoxin Center of Excellence was launched as a start-up. Innovation has always been a driver, supported by important investments in R&D. Today, not only are we experts in the foundational science, but we have applied this knowledge to the full development of our solutions, meaning we have a deep understanding of our test system. bioMérieux’s solutions for endotoxin detection combine a strong innovative spirit with customer vision. We strive to be in constant contact with our customers — knowing their needs and expectations helps us define our strategy for the future. 

A great illustration of our dedication to scientific innovation is recombinant horseshoe crab factor C (rFC), the synthetic analogue to the native endotoxin-specific principal receptor in the Limulus Amebocyte Lysate (LAL) cascade. Instead of relying on an animal source, we provide our clients with a sustainable alternative method aligned with regulatory requirements. With this technology, we can guarantee high-quality, robust products, batch reproducibility and the ability to scale up easily. 

We want to support our customers in regard to compliance with sustainability requirements.. For instance, it was clear from the beginning that we wouldn’t source from any animal species, and we’re also fully engaged in the “3Rs” principle: reduce, replace and refine. We want to develop tests that use less consumables and replace plastic with environmentally friendly alternatives.

Today, ENDONEXT™ is our flagship solution in the field of sustainability. Based on Factor C, this technology helps to preserve the horseshoe crab population and the ecosystem that depends on these creatures. ENDONEXT™ also improves the efficiency of our customers’ labs. With 100% endotoxin specificity, lot-to-lot consistency and more streamlined workflows, we’re able to provide reliable results from in-process controls to final product testing on the most challenging matrices.

Whenever it is necessary, we make the required human and technical investments to help keep our customers compliant and audit ready. 

There have been many evolutions and innovations within the endotoxin detection domain over the last 20 years. Today, our products work very well — we’re very proud of them — and we are anticipating the next 20 years with enthusiasm. We have many ideas for new developments for our portfolio that will help our customers fulfill their needs in the field of pharma quality control.