Expert Support At Your Fingertips for the Bacterial Endotoxins Test

Become a QC Insider™ Expert and Register Now.

 

 

 

QC Insider - Endotoxin Expertise at Your Fingertips™

 

Since 2013, Low Endotoxin Recovery (LER) has been a topic of debate in the endotoxin detection community. LER has been defined as the masking of endotoxin in undiluted biological drug products, such as monoclonal antibodies, vaccines and other protein products. It has been linked to the use of polysorbate in conjunction with a chelating buffer, specifically, citrate and phosphate buffers. To help ensure our QC Insider™ Experts are equipped with the latest information regarding LER, we have developed a few resources now available in our QC Insider™ Toolbox.

 

Technical Tip, “LER – Frequently Asked Questions (FAQs),” accessible via our QC Insider™ Library, addresses questions such as:

  • What is the FDA’s current position on LER?
  • What are some considerations for conducting a proper hold-time study?
  • What is naturally occurring endotoxin (NOE), and is there an advantage to its use?

 

Archived Webinar, “LER - Context and Resolution from a Broad Biologics Test Perspective” accessible via  QC Insider™ Training, discusses what, other than pyrogenicity, is becoming relevant to endotoxin testing, how biologics are different, and why the idea that “LER doesn’t matter” is quickly diminishing.

 

Already a Subscriber to the QC Insider™ Toolbox?
Click on LER FAQs Technical Tip or Archived Webinar, input your user name and password on the login page. You will then be directed to the respective landing page to access the tool.

 

Not a QC Insider™ Expert Yet?
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 LER tools.

 

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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White Paper: PyroGene™ Recombinant Factor C Assay
Endotoxin Testing: It’s Time to Embrace the Alternative                                                    

 

Topics include:

  • The growing demand of a natural resource
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  • How to validate the PyroGene™ rFC Assay                                                    

      

Login or register to access the new PyroGene™ rFC White Paper.            

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