Comparison of Limulus Amoebocyte Lysate and Recombinant Factor C Assays for Endotoxin Detection in Four Human Vaccines with Complex Matrices

Marine Marius; Frédéric Vacher; Thierry Bonnevay

doi:10.5731/pdajpst.2019.010389

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Comparison of Limulus Amoebocyte Lysate and Recombinant Factor C Assays for Endotoxin Detection in Four Human Vaccines with Complex Matrices

Marine Marius, Frédéric Vacher and Thierry Bonnevay

PDA Journal of Pharmaceutical Science and Technology July 2020, 74 (4) 394-407; DOI: https://doi.org/10.5731/pdajpst.2019.010389

Marine Marius

Analytical Sciences, Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy l'Etoile, France

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For correspondence: marine.marius@sanofi.com

Frédéric Vacher

Analytical Sciences, Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy l'Etoile, France

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Thierry Bonnevay

Analytical Sciences, Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy l'Etoile, France

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vol. 74 no. 4 394-407

DOI

https://doi.org/10.5731/pdajpst.2019.010389

PubMed

32179709

Published By

Parenteral Drug Association (PDA)

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1079-7440

Online ISSN

1948-2124

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Published online July 31, 2020.

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previous version (March 16, 2020 - 09:12).
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Marine Marius*,
Frédéric Vacher and
Thierry Bonnevay

Analytical Sciences, Sanofi Pasteur, 1541 Avenue Marcel Mérieux, 69280 Marcy l'Etoile, France

↵*Corresponding Author: Analytical Sciences, Microbiology Platform, Sanofi Pasteur, 1541 avenue Marcel Mérieux, 69280 Marcy l'Etoile, France. Telephone: +33 (0)437 370 100; E-mail: marine.marius{at}sanofi.com

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Comparison of Limulus Amoebocyte Lysate and Recombinant Factor C Assays for Endotoxin Detection in Four Human Vaccines with Complex Matrices

Marine Marius, Frédéric Vacher, Thierry Bonnevay

PDA Journal of Pharmaceutical Science and Technology Jul 2020, 74 (4) 394-407; DOI: 10.5731/pdajpst.2019.010389

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Comparison of Limulus Amoebocyte Lysate and Recombinant Factor C Assays for Endotoxin Detection in Four Human Vaccines with Complex Matrices

Marine Marius, Frédéric Vacher, Thierry Bonnevay

PDA Journal of Pharmaceutical Science and Technology Jul 2020, 74 (4) 394-407; DOI: 10.5731/pdajpst.2019.010389

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Keywords

Endotoxin testing
LAL-based endotoxin assay
recombinant factor C (rFC) endotoxin assay
human vaccines

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Comparison of Limulus Amoebocyte Lysate and Recombinant Factor C Assays for Endotoxin Detection in Four Human Vaccines with Complex Matrices

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