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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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Article Information

vol. 68 no. 5 472-477
DOI 
https://doi.org/10.5731/pdajpst.2014.00999
PubMed 
25336418

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 21, 2014.

Copyright & Usage 
© PDA, Inc. 2014

Author Information

  1. Jay S. Bolden*,
  2. Mark E. Claerbout,
  3. Matthew K. Miner,
  4. Marie A. Murphy,
  5. Kelly R. Smith and
  6. Rob E. Warburton
  1. Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN
  1. ↵*Corresponding Author: Jay Bolden, Lilly Corporate Center, Indianapolis, IN 46285. Phone: +1-317-276-9183; e-mail: bolden_jay{at}lilly.com
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    Scientific Reports 2017 7 1
  • Lipopolysaccharide Structure and the Phenomenon of Low Endotoxin Recovery
    Amy Gorman, Alexander P. Golovanov
    European Journal of Pharmaceutics and Biopharmaceutics 2022 180
  • Masking of endotoxin in surfactant samples: Effects on Limulus-based detection systems
    Johannes Reich, Pierre Lang, Holger Grallert, Hubert Motschmann
    Biologicals 2016 44 5
  • Endotoxin recovery using limulus amebocyte lysate (LAL) assay
    Jay S. Bolden, Rob E. Warburton, Robert Phelan, Marie Murphy, Kelly R. Smith, Michael R. De Felippis, Dayue Chen
    Biologicals 2016 44 5
  • Low Endotoxin Recovery—Masking of Naturally Occurring Endotoxin
    Johannes Reich, Felix Weyer, Hiroshi Tamura, Isao Nagaoka, Hubert Motschmann
    International Journal of Molecular Sciences 2019 20 4
  • Detection of innate immune response modulating impurities (IIRMI) in therapeutic peptides and proteins: Impact of excipients
    Seth G. Thacker, Cheng Her, Logan Kelley-Baker, Derek D C. Ireland, Mohanraj Manangeeswaran, Eric S. Pang, Daniela Verthelyi
    Frontiers in Immunology 2022 13
  • Low endotoxin recovery and its impact on endotoxin detection
    Yuan Cao, Yujie Zhang, Frank Qiu
    Biopolymers 2021 112 11
  • Monocyte Activation Test (MAT) as a possibility of replacement for the rabbit pyrogen test in hyperimmune sera
    Carla Lilian de Agostini Utescher, Klariane Laís Buosi, Viviane Fungaro Botosso, Wagner Quintilio
    Brazilian Journal of Pharmaceutical Sciences 2018 54 2
  • Teste de endotoxina por Fator C recombinante para solução injetável de cloreto de sódio 0,9%
    Ellen Hilinski, Daniela Dal Molim Ghisleni, Carla Lilian de Agostini Utescher, Wagner Quintilio, Adriana Aparecida Buzzo Almodovar, Adriana Bugno, Terezinha de Jesus Andreoli Pinto
    Revista do Instituto Adolfo Lutz 2024 83
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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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