ENDONEXT
The evolution in Endotoxin Detection
Leaders in endotoxin analysis with recombinant technology.
One of the main goals is to innovate in endotoxin detection while protecting the patient. ENDONEXT ™ endotoxin detection assays based on recombinant factor C (rFC), present in horseshoe crab, provide the performance needed for speed and efficiency during in-process control, product release, and solutions for the most complex matrices during the manufacturing process. The use of synthetic rFC instead of horseshoe crab blood cell-based not only ensures ecological sustainability and supply reliability, but also provides unprecedented accuracy, sensitivity, and batch-to-batch uniformity.
Key benefits:
● 100% endotoxin specificity, with no false positive results due to ß-glucans or interference caused by cloudy or colored samples.
● Approved for use and validated in the same way as LAL (Limulus Amebocyte Lysate), following the BET (Bacterial Endotoxin Test) sections of the Pharmacopoeia.
● Increased accuracy and rate of valid results with time savings and batch-to-batch uniformity. BioMérieux is delivering faster, simpler, and more environmentally friendly endotoxin tests by mimicking nature rather than abusing it. These tests allow for safe in-process control and decision-making regarding the release of pharmaceutical products and medical devices.
The ENDONEXT ™ range, time and cost saving methods:
ENDOZYME® II GO
Therapid GO version of ENDOZYME®II features GOPLATE ™, a pre-filled microplate with the required standard curve and positive product control concentrations. (PPC).
• Eliminates manual preparation of PPC standard dilutions
• More than 50% reduction of handling time with respect to conventional microplates assays
• Significantly reduces the risk of handling error
• Ideal for in-process control of water and raw materials, as well as analysis for product release
• Easy automation
ENDOZYME® II
The optimized second generation ENDOZYME® is a flexible and easy-to-use assay for endotoxin detection
• State-of-the-art sensitivity below 0.001 EU / ml
• Flexible titration time according to required sensitivity
• Particularly suitable for end-product analysis, formulation, and research
ENDOLISA®
With a single integrated sample preparation step, the ENDOLISA® assay revolutionizes endotoxin analysis of complex samples.
• The ELISA-like format features a precoated 96-well plate with a specific endotoxin-binding protein found in bacteriophages.
• Exceeds the limits of traditional methods such as inhibition and amplification
• Unprecedented tolerance to detergents and organic solvents
BIOMERIEUX
• ENDONEXT®