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Research ArticlePDA Paper

Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review

Jay Bolden, Chris Knutsen, Jack Levin, Catherine Milne, Tina Morris, Ned Mozier, Ingo Spreitzer and Friedrich von Wintzingerode
PDA Journal of Pharmaceutical Science and Technology September 2020, 74 (5) 602-611; DOI: https://doi.org/10.5731/pdajpst.2020.012187
Jay Bolden
1Eli Lilly and Company;
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  • For correspondence: jbolden@lilly.com
Chris Knutsen
2Bristol Myers Squibb;
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Jack Levin
3University of California School of Medicine, San Francisco, CA;
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Catherine Milne
4European Directorate for the Quality of Medicines and HealthCare, France;
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Tina Morris
5American Association of Pharmaceutical Scientists;
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Ned Mozier
6Pfizer;
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Ingo Spreitzer
7Paul-Ehrlich-Institute, Germany; and
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Friedrich von Wintzingerode
8Roche-Genentech
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Article Information

vol. 74 no. 5 602-611
DOI 
https://doi.org/10.5731/pdajpst.2020.012187
PubMed 
32817324

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online October 5, 2020.

Article Versions

  • previous version (August 14, 2020 - 07:58).
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Copyright & Usage 
© PDA, Inc. 2020

Author Information

  1. Jay Bolden1,*,
  2. Chris Knutsen2,
  3. Jack Levin3,
  4. Catherine Milne4,
  5. Tina Morris5,
  6. Ned Mozier6,
  7. Ingo Spreitzer7 and
  8. Friedrich von Wintzingerode8,i
  1. 1Eli Lilly and Company;
  2. 2Bristol Myers Squibb;
  3. 3University of California School of Medicine, San Francisco, CA;
  4. 4European Directorate for the Quality of Medicines and HealthCare, France;
  5. 5American Association of Pharmaceutical Scientists;
  6. 6Pfizer;
  7. 7Paul-Ehrlich-Institute, Germany; and
  8. 8Roche-Genentech
  1. ↵*Corresponding Author: Global Quality Laboratories Eli Lilly and Company, Lilly Corporate Center, Indianapolis IN 46285; E-mail: jbolden{at}lilly.com
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PDA Journal of Pharmaceutical Science and Technology: 74 (5)
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 5
September/October 2020
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Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review
Jay Bolden, Chris Knutsen, Jack Levin, Catherine Milne, Tina Morris, Ned Mozier, Ingo Spreitzer, Friedrich von Wintzingerode
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 602-611; DOI: 10.5731/pdajpst.2020.012187

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Currently Available Recombinant Alternatives to Horseshoe Crab Blood Lysates: Are They Comparable for the Detection of Environmental Bacterial Endotoxins? A Review
Jay Bolden, Chris Knutsen, Jack Levin, Catherine Milne, Tina Morris, Ned Mozier, Ingo Spreitzer, Friedrich von Wintzingerode
PDA Journal of Pharmaceutical Science and Technology Sep 2020, 74 (5) 602-611; DOI: 10.5731/pdajpst.2020.012187
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Keywords

  • Endotoxin testing
  • Recombinant factor C
  • Amebocyte lysates
  • LAL
  • rFC
  • Horseshoe crabs
  • Environmental endotoxin
  • Recombinant technologies

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