Expands its offering for the detection of endotoxins in pharmaceutical products
BioMérieux, a global player in in vitro diagnostics and a leader in industrial microbiological control, has purchased Hyglos, a specialist in the detection of endotoxins.
Under the terms of the deal BioMérieux will pay €24m for the Bernried, Germany-based firm, phased over the next three years.
Founded in 2009, Hyglos has expertise in the development and production of recombinant proteins used for the detection of endotoxins in pharmaceutical products.
Endotoxins, a component of the outer membrane of certain Gram-negative bacteria, are pyrogenic substances, i.e. they cause high fevers.
Pharmacopoeial standards require that this type of substance is 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 endotoxins are quantified in raw materials such as water, or work-in-process materials.
Endotoxin detection relies on the use of reagents developed using a purified blood fraction taken from a horseshoe crab (Limulidae), a family of crab endangered in Asia and protected in the US 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 endotoxins using a chain of standardised reactions. Moreover, when certain formulations are used in the manufacturing of biotechnological medicines, they can hide or 'mask' endotoxins; Hyglos has developed a unique technology for 'demasking' endotoxins and making their detection possible, even in such cases.
'Hyglos’ expertise in the field of recombinant proteins opens new horizons for the detection of endotoxins,' said Nicolas Cartier, Head of BioMérieux's Industry Unit.
'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.'
The current endotoxin detection market is worth around €250m, an increase of around 12% per year, according to Markets and Markets. This growth is particularly supported by the increase in the volume of drugs derived from biotechnology, medical devices and vaccines.