Description
PYROSTAR™ Neo is a recombinant reagent intended to be used as a synthetic alternative to LAL reagent for endotoxin testing and detection. It uses a colorimetric method that can be quantified with an absorbance microplate reader similar to traditional chromogenic LAL reagent.
PYROSTAR™ Neo is 100% horseshoe crab-free and closely mimics the biochemical cascade of traditional LAL with 3 recombinant factors (Factor C, Factor B, and proclotting enzyme) instead of only 1 recombinant factor such as with recombinant Factor C (rFC) reagents.
PYROSTAR™ Neo is also an endotoxin-specific reagent that eliminates the risk of false positives from (1-->3)ß-D-Glucan.
PYROSTAR™ Neo has a very wide quantitative range of 0.001 EU/mL to 50 EU/mL, allowing for a highly sensitive assay with less lot-to-lot variation.
PYROSTAR™ Neo can be easily validated for use as an alternative method to endotoxin testing. FUJIFILM provides a validation package that includes results and a procedure that users can easily follow to validate PYROSTAR™ Neo as a compendial method and provides training and technical support.
With the draft chapter USP <86> in final review, it is expected that PYROSTAR™ Neo will now support a compendial method, and users will only need to perform method suitability testing, just as with LAL.
PYROSTAR™ Neo can be used for endotoxin testing of parenteral drugs, medical devices, injectables, waters, and radiopharmaceuticals among many other items in the healthcare field.
PYROSTAR™ Neo can be used for environmental monitoring in various healthcare fields as well and end-product and in-process testing. It can be easily validated.