Advertorial

Expert view: Low Endotoxin Recovery (LER)

12
SHARES

The Parenteral Drug Association (PDA) has recently published Technical Report No. 82 (TR82) on the topic of Low Endotoxin Recovery (LER), providing both consensus to the science and data behind the analytical issue, as well as to analytical and mitigation strategies.

Join our free webinar: The Future of Sterility Testing: One-Day Results with Advanced RT-rt PCR Technology

Join this webinar to find out how RT-rt PCR is revolutionising sterility testing and discover a unique approach that provides reliable one-day results and enhanced sensitivity and detection capabilities.

Date: 5 Nov | Time: 15:00 BST

REGISTER NOW TO SECURE YOUR SPOT <<<

Can’t attend live? No worries – register to receive the recording post-event.

 

 

ACCESS your FREE COPY

 


This report addresses the key factors shaping pharmaceutical formulation, including regulation, QC and analysis.

Access the full report now to discover the techniques, tools and innovations that are transforming pharmaceutical formulation, and learn how to position your organisation for long-term success.

What you’ll discover:

  • Key trends shaping the pharmaceutical formulation sector
  • Innovations leading progress in pharmaceutical formulation and how senior professionals can harness their benefits
  • Considerations and best practices when utilising QbD during formulation of oral solid dosage forms
  • And more!

Don’t miss your chance to access this exclusive report ! Access now – it’s free

What is PDA TR82?

In March 2019, the PDA published TR82 on LER. The report constitutes a much‑needed source of information and guidance, including scientific findings on the mechanism behind the analytical issue. It also includes recommended procedures for analysis and mitigation of endotoxin masking commonly leading to LER in biologics. This comprehensive document is a result of three years intensive work completed by the PDA LER Task Force, which consists of members from the US FDA, academia, pharmaceutical industry and all endotoxin testing suppliers. TR82 is available in full for members and can be purchased directly from the PDA Technical Reports Portal.

What are TR82’s biggest takeaways?

TR82 is an important scientific and guidance document that will give pharmaceutical companies leverage for the successful mitigation of the LER phenomenon, with the ultimate outcome of increased process and product knowledge. Important takeaways of the report are: 1) a description of the underlying mechanisms and contributing factors of LER, 2) a summary of the potential clinical impact, 3) clear guidelines for conducting LER hold-time studies and 4) a choice of strategies for the mitigation of LER are made available for the industry.

What are the outcomes of Case Study 7: evaluation of an endotoxin demasking protocol, in TR82?

An important part of TR82 is the comprehensive appendix of case studies considering LER occurrences, encompassing both analyses of root-causes and endotoxin preparations, as well as methodologies for overcoming LER. In one of the studies, Case Study 7: evaluation of an endotoxin demasking protocol, the application of the ENDO-RS method, developed by Hyglos – a bioMérieux company, was assessed. This study used a sample known to be affected by LER to evaluate a sample preparation protocol using ENDO-RS reagents prior to detection of endotoxin using the LAL method. The results showed that the ENDO-RS protocol was able to reliably detect the endotoxin under all conditions tested, ensuring robust recovery and diminishing the risk of false‑negative test results.

What is the ENDO-RS® method?

The ENDO-RS method is a patented set of reagents for sample preparation addressing the masking of endotoxin in biopharmaceutical formulations typically containing surfactants, chelating agents or specific active pharmaceutical ingredients (APIs). ENDO-RS enables full quantitative recovery of endotoxin prior to detection, independent of storage time and endotoxin concentration. bioMérieux provides specialised protocol development services applying ENDO-RS. Our work for leading pharmaceutical companies has resulted in validated methods for LER, fulfilling regulatory requirements.

 

Share via
Share via