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

doi:10.5731/pdajpst.2020.012187

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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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.

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previous version (August 14, 2020 - 07:58).
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Author Information

Jay Bolden¹,*,
Chris Knutsen²,
Jack Levin³,
Catherine Milne⁴,
Tina Morris⁵,
Ned Mozier⁶,
Ingo Spreitzer⁷ and
Friedrich von Wintzingerode⁸,ⁱ

¹Eli Lilly and Company;
²Bristol Myers Squibb;
³University of California School of Medicine, San Francisco, CA;
⁴European Directorate for the Quality of Medicines and HealthCare, France;
⁵American Association of Pharmaceutical Scientists;
⁶Pfizer;
⁷Paul-Ehrlich-Institute, Germany; and
⁸Roche-Genentech

↵*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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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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