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PDA Journal of Pharmaceutical Science and Technology

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Research ArticleResearch

Evidence Against a Bacterial Endotoxin Masking Effect in Biologic Drug Products by Limulus Amebocyte Lysate Detection

Jay S. Bolden, Mark E. Claerbout, Matthew K. Miner, Marie A. Murphy, Kelly R. Smith and Rob E. Warburton
PDA Journal of Pharmaceutical Science and Technology September 2014, 68 (5) 472-477; DOI: https://doi.org/10.5731/pdajpst.2014.00999
Jay S. Bolden
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN
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  • For correspondence: bolden_jay@lilly.com
Mark E. Claerbout
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN
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Matthew K. Miner
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN
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Marie A. Murphy
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN
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Kelly R. Smith
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN
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Rob E. Warburton
Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN
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References

  1. 1.↵
    Chapter <85> Bacterial Endotoxins Test. In United States Pharmacopeia; United States Pharmacopeial Convention: Rockville, MD, 2013.
  2. 2.↵
    Chapter 2.6.14 Bacterial Endotoxins. In European Pharmacopoeia; The European Directorate for the Quality of Medicines & Health Care: Strasbourg, France, 2014.
  3. 3.↵
    Chapter 4.01 Bacterial Endotoxins Test. In Japanese Pharmacopoeia; Japanese Ministry of Health, Labour and Welfare: Tokyo, Japan, 2011.
  4. 4.↵
    U.S. Department of Health and Human Services, Food and Drug Administration, Guidance for Industry—Pyrogen and Endotoxin Testing: Questions and Answers, June 2012.
  5. 5.↵
    1. Chen J.
    Low Endotoxin Recovery in Common Biologic Products. Presented at PDA 8th Annual Global Conference on Pharmaceutical Microbiology, Bethesda, MD, 2013.
  6. 6.
    1. Bowers K.,
    2. Tran L.
    Creation of an in-house naturally occurring endotoxin preparation for use in endotoxin spiking studies and LAL sample hold time analysis. Am. Pharm. Rev. 2011, 14 (6).
  7. 7.↵
    1. Williams K.
    Endotoxin test concerns of biologics. Am. Pharm. Rev. 2013, 16 (6).
  8. 8.↵
    1. McCullough K.
    The Bacterial Endotoxins Test: A Practical Guide. PDA and Davis Healthcare International Publishing, LLC: River Grove, IL, 2011; pp 48–49.
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PDA Journal of Pharmaceutical Science and Technology: 68 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 68, Issue 5
September/October 2014
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Evidence Against a Bacterial Endotoxin Masking Effect in Biologic Drug Products by Limulus Amebocyte Lysate Detection
Jay S. Bolden, Mark E. Claerbout, Matthew K. Miner, Marie A. Murphy, Kelly R. Smith, Rob E. Warburton
PDA Journal of Pharmaceutical Science and Technology Sep 2014, 68 (5) 472-477; DOI: 10.5731/pdajpst.2014.00999

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Evidence Against a Bacterial Endotoxin Masking Effect in Biologic Drug Products by Limulus Amebocyte Lysate Detection
Jay S. Bolden, Mark E. Claerbout, Matthew K. Miner, Marie A. Murphy, Kelly R. Smith, Rob E. Warburton
PDA Journal of Pharmaceutical Science and Technology Sep 2014, 68 (5) 472-477; DOI: 10.5731/pdajpst.2014.00999
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Keywords

  • Bacterial endotoxins
  • Masking
  • pyrogens
  • Chromogenic
  • Recombinant factor C
  • Phosphate
  • Citrate
  • Polysorbate

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