Expert Support At Your Fingertips for the Bacterial Endotoxins Test

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QC Insider - Endotoxin Expertise at Your Fingertips™


Although the PyroGene™ recombinant Factor C Assay has been commercially available since 2003, it has recently experienced a boost in interest. This renewed interest is primarily due to a rapidly expanding acceptance of the recombinant Factor C test method by global regulatory authorities resulting in a growing number of users adopting alternative endotoxin methods.


In 2018, proof of the method’s equivalency to LAL was confirmed when the FDA approved the application for the first drug product marketed in the United States using the recombinant Factor C method as its endotoxin release test method.   


There are several other reasons why the industry has reached a critical point where we can no longer rely on a potentially finite natural resource, and where a sustainable and alternative means of endotoxin detection is necessary.


Learn why more companies are considering an alternative method for their endotoxin testing.


Our White Paper topics include: 


  • The growing demand of a natural resource
  • Benefits of the synthetic version of Factor C   
  • How to validate the PyroGene™ rFC Assay: it’s easier than you think   


Already a Subscriber to the QC Insider™ Toolbox?    Not a QC Insider™ Expert Yet? 
After clicking on White Paper, input your user name and password on the login page. You will then be directed to the White Papers page where you can access the latest tool.   Register and you will be directed to a Registration Page. After you have successfully registered, you will be able to navigate through the QC Insider™ Toolbox and access the White Paper.


Delivered to you from the QC experts who face many of the same regulated manufacturing challenges as you do, the QC Insider™ Toolbox is packed with comprehensive support tools that will help you perform the bacterial endotoxins test.


Become a QC Insider™ expert and Register Now.




Explore Our Resources


QC Insider™ Support: direct access to one-on-one guidance and detailed information about software support, recertification & testing services, reader install & maintenance and workflow optimization.


QC Insider™ Training: self-directed training resources that will help you build on your bacterial endotoxins test expertise.


QC Insider™ Library: technical resources that will help ensure your success with the bacterial endotoxins test. You will have access to a collection of package inserts, quick guides, technical tips and more.


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On-demand Webinar: Automated Endotoxin Testing


Our webinar, "Streamlining Your QC Testing: Automated Endotoxin Testing and Process Optimization" demonstrates how users are able to automate the liquid handling aspect of the endotoxin test and improve compliance with data integrity regulations.     


Topics discussed: 

  • What is assay automation?                               
  • Potential data integrity gaps in manual procedures
  • Case Study: automated vs. manual endotoxin testing     


Login or register to to view the webinar.