While each pharmaceutical validation provides the necessary foundation for the testing of specific products via recombinant Factor C (rFC) without external reference, there are also several published studies that support the equivalence of recombinant technology.
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Pharmaceutical and medical device manufacturers can now use the compendial chapter 2.6.32.
Expert view: The right endotoxin detection solution for you – bioMérieux’s complete portfolio of rFC endotoxin assays
As part of any general pyrogen testing strategy, the detection of even minute traces of the highly pyrogenic bacterial molecule called lipopolysaccharide (LPS, also named endotoxin) in pharmaceutical samples is mandatory to ensure patient safety.
In this whitepaper, bioMérieux describe the potential application of BioFire® FilmArray technology – a well-recognised technology used in infectious disease diagnostics – for rapid at-line detection of mycoplasmas in the pharmaceutical industry.
THE ADVANTAGES of the recombinant Factor C (rFC) test lie in its (a) scientific characterisation, (b) sustainability and (c) specificity. In light of diminishing horseshoe crab populations, sustainability has been mandated via regulations that include the concept of the “3 Rs”: replacement, reduction and refinement of analytical tests and reagents…
Karolina Heed from the endotoxin unit Hyglos at bioMérieux introducing rapid ENDOZYME® II GO, the latest member of bioMérieux’s ENDONEXT™️ range of endotoxin detection assays based on sustainable recombinant horseshoe crab Factor C (rFC).
bioMérieux launches ENDOZYME® II GO, an innovative test for the detection of endotoxins in pharmaceutical microbiology control
bioMérieux, a world leader in the field of industrial microbiological control, announces the launch of ENDOZYME® II GO, a new endotoxin test in the bioMérieux ENDONEXT™ range of recombinant horseshoe crab Factor C (rFC) assays.