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White Paper: Low Endotoxin Recovery - Beyond the Controversy


LER is defined as the failure to detect a known amount of spiked endotoxin in an undiluted drug product over multiple time points. Since its discovery in 2013, LER continues to be a topic of debate and a complex challenge for the endotoxin testing community.

Lonza’s LER White Paper, available for download in the QC Insider™ Toolbox, provides the latest understanding of the LER phenomenon. Topics include:

  • The impact of LER on pharmaceutical manufacturing
  • Update on guidance from regulatory authorities
  • How to manage LER in your daily work

Download the White Paper: LER: Beyond the Controversy


    

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Date Published: 20th March 2017

Source article link: Lonza Pharma&Biotech – Bioscience Solutions


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Lonza Pharma&Biotech - Bioscience Solutions

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Tel: +[1] 800-521-0390

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