167 1 2 Divided By 2 The Recombinant Factor C Assay rFC is an effective animal free solution for bacterial endotoxin detection testing BET
ENDOTOXIN TESTING The benefits from switching from LAL to rFC based bacterial endotoxin tests has been clearly identified by diferent regulatory bodies refer to the rFC test which they The PyroGene rFC method is a quantitative assay that is run on a 96 well plate incubated in a microplate reader at 37 C that measures fluorescence with excitation emission wavelengths at
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The USP Microbiology Expert Committee officially approved the use of recombinant Factor C for endotoxin testing in July 2024 Advancements in recombinant protein technology have led to the development of the recombinant Factor C rFC testing method This method offers a more sustainable and
In 2018 FDA approved the first drug that used an endotoxin test based on the recombinant Factor C rFC reagent This opened the door for wider adoption of the rFC test Endotoxin detection by LAL test or rFC test checks the safety namely absence of endotoxins sterile pharmaceutical products for human consumption In addition the detection of
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Therefore rFC based tests were found to represent reliable methods as equivalent or even superior to LAL assays and suitable for routine bacterial endotoxin testing The method described involves the use of a recombinant factor C rFC based on the gene sequence of the horseshoe crab and fluorimetric detection in keeping with the kits
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The Recombinant Factor C Assay rFC is an effective animal free solution for bacterial endotoxin detection testing BET
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ENDOTOXIN TESTING The benefits from switching from LAL to rFC based bacterial endotoxin tests has been clearly identified by diferent regulatory bodies refer to the rFC test which they
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167 1 2 Divided By 2 - In 2018 FDA approved the first drug that used an endotoxin test based on the recombinant Factor C rFC reagent This opened the door for wider adoption of the rFC test
