Endotoxins are a component of the outer membrane of certain Gram-negative bacteria. They are pyrogenic substances, i.e. they cause high fevers. Pharmacopoeial standards require that this type of substance be absent from pharmaceutical products that come into contact with the bloodstream or the central nervous system such as injectable drugs or medical devices. It is also recommended that the endotoxins be quantified in raw materials such as water, or work-in-process materials.
Today, endotoxin detection relies on the use of reagents developed based on a purified blood fraction taken from a horseshoe crab (Limulidae), a family of crab endangered in Asia and protected in the United States and whose blood has the ability to coagulate in the presence of minute amounts of bacterial endotoxins.
Hyglos has developed an innovative method from recombinant proteins, which eliminates the need for horseshoe crab blood and thus allows for the detection of the presence of endotoxins using a chain of completely standardized reactions. Moreover, when certain formulations are used in the manufacturing of biotechnological medicines, they can hide or "mask" endotoxins; Hyglos has developed a unique and original technology for "demasking" endotoxins, i.e. making endotoxin detection possible, even in such cases.
“Hyglos’ expertise in the field of recombinant proteins opens new horizons for the detection of endotoxins. True to our pioneering spirit, we are convinced of the relevance of its innovative method. Its existing product portfolio has enriched our offering of microbiological control solutions for the pharmaceutical industry and medical devices", states Nicolas Cartier, Head of bioMérieux's Industry Unit.
Dr. Wolfgang Mutter, Managing Director of Hyglos, adds: “We are very pleased to join bioMérieux. Its global leadership in industrial microbiological control and the scope of its commercial network creates promising perspectives that allow pharmaceutical manufacturers to benefit from the scientific and technical soundness of the products that we have developed for reliable and efficient endotoxin detection.”
The endotoxin detection market is today estimated at €250 million, an increase of around 12% per year[1], particularly supported by the growth in the volume of drugs derived from biotechnology, medical devices and vaccines.
The total consideration paid by bioMérieux to acquire 100% of Hyglos shares will amount to €24 million, phased over the next 3 years. The transaction was closed on May 31, 2016.
Hyglos will be consolidated in the Group’s financial statements from June 1st, 2016.