With the USP recently rejecting recombinant Factor C (rFC) as a compendial endotoxin test, the technology has been receiving more attention in the media and our industry. Late 2019, we presented our initial LAL and recombinant study data from global pharmaceutical organizations’ water samples. After a careful analysis of the data, we conducted a second, larger study with hundreds of global water samples evaluating the ruggedness, repeatability, and specificity of commercially available recombinant Factor C products, as well as our own recombinant product in development, against a large panel of endotoxins.
View this webinar for a discussion of these new results and learn where recombinant products stacked up against LAL when it comes specificity and non-inferiority when testing relevant, real-world contaminated pharmaceutical water samples.
Associate Director of Endotoxin Products
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