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The Analytical Reality of Recombinant Endotoxin Technologies

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The Analytical Reality of Recombinant Endotoxin Technologies


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Webinar Overview

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.


WEBINAR PRESENTER

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Nicola Reid

Associate Director of Endotoxin Products

Charles River


 

We are providing digital education options to keep you learning about topics you may be interested in. For more information, visit criver.com/digital-education.


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In today’s world, quality and compliance are non-negotiable, and yesterday’s standards are no longer sufficient to meet the demands of a constantly evolving landscape. The field of quality control microbiology is undergoing a disruptive revolution to safeguard patient safety, evolving beyond traditional methods to optimize resources, minimize human error, enable sustainable alternatives, and maintain consistent quality standards. Every test, every result, and every data point define the success of life-changing therapies. That’s why we’re leading a new paradigm, one that redefines efficiency, sustainability, and innovation. Let’s rethink the future of microbial quality control, where modern, automated, data-centric, and scalable solutions are the norm, empowering you to stay ahead in a dynamic regulatory and operational landscape.  Together, we are not just preparing for the future. We’re rethinking it. Because every moment matters.

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This post is related to:

Contamination Control: Quality Control, Lab Testing Services
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