Expert Support At Your Fingertips for the Bacterial Endotoxins Test
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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.
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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