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

References

1. 1.↵
   1. Rajendran V.,
   2. Al Aboody M.,
   3. Alturaiki W.,
   4. Sandle T.

   Review on Endotoxin Mediated Toxic Anterior Segment Syndrome (TASS) in Ophthalmic Products—Outbreaks, Product Recall and Testing Limits. Eur. J. Parent. Pharmaceut. Sci. 2017, 22 (1), 20–25.

   OpenUrl
2. 2.↵
   1. Bone H. G.,
   2. Schenarts P. J,
   3. Booke M.,
   4. McGuire R.,
   5. Harper D.,
   6. Traber L. D.,
   7. Traber D. L.

   Oxalated Pyridoxalated Hemoglobin Polyoxyethylene Conjugate Normalizes the Hyperdynamic Circulation in Septic Sheep. Crit. Care Med. 1997, 25 (6), 1010–1018.

   OpenUrlCrossRefPubMedWeb of Science
3. 3.↵
   1. Henderson B.,
   2. Poole S.,
   3. Wilson M.

   Microbial/Host Interactions in Health and Disease: Who Controls the Cytokine Network? Immunopharmacology 1996, 35 (1), 1–21.

   OpenUrlCrossRefPubMedWeb of Science
4. 4.↵
   1. Williams K. L.

   1. Williams K. L.

   Limulus Amebocyte Lysate Discovery, Mechanism and Application. In Endotoxins: Pyrogens, LAL Testing and Depyrogenation, 3rd ed.; Williams K. L., Ed.; CRC Press: Boca Raton, FL, 2007; Chapter 10, pp 191–220.
5. 5.↵
   1. Rangel-Frausto M. S.

   The Epidemiology of Bacterial Sepsis. Infect. Dis. Clin. North Am. 1999, 13 (2), 299–312.

   OpenUrlCrossRefPubMedWeb of Science
6. 6.↵
   Council of Europe, Bacterial Endotoxins, Chapter 2.6.14. In European Pharmacopoeia (Ph. Eur.), 9th Edition, Council of Europe: Strasbourg, France, 2016.
7. 7.↵
   U.S. Food and Drug Administration, Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, 2012. U.S. Food and Drug Administration Web site. https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm314718.htm (accessed February 15, 2019).
8. 8.↵
   Ministry of Health, Labour and Welfare of Japan, General Tests, Process and Apparatus—4.01: Bacterial Endotoxins Test. In The Japanese Pharmacopoeia, 17th Edition (English Version), MHLW: Tokyo, 2016; pp 110–113.
9. 9.↵
   U.S. Pharmacopeial Convention, General Chapter <85> Bacterial Endotoxins Test. In USP 39—NF 34, USP: Rockville, MD, 2015, pp 161–167.
10. 10.↵
    1. Wang X.,
    2. Quinn P. J.

    1. Ding J. L.,
    2. Ho B.

    Endotoxin Detection—from Limulus Amebocyte Lysate to Recombinant Factor C. In Endotoxins: Structure, Function and Recognition; Wang X., Quinn P. J., Eds.; Springer Netherlands: Dordrecht, 2010; pp 187–208.
11. 11.↵
    1. Obayashi T.,
    2. Tamura H.,
    3. Tanaka S.,
    4. Ohki M.,
    5. Takahashi S.,
    6. Aral M.,
    7. Masuda M.,
    8. Kawai T.

    A New Chromogenic Endotoxin-Specific Assay Using Recombined Limulus Coagulation Enzymes and Its Clinical Applications. Clin. Chim. Acta 1985, 149 (1), 55–65.

    OpenUrlCrossRefPubMedWeb of Science
12. 12.↵
    1. Sandle T.

    Pharmaceutical Product Impurities: Considering Beta Glucans. Am. Pharm. Rev. 2013, 16 (5), 16–19.

    OpenUrl
13. 13.↵
    1. Chen L.,
    2. Mozier N.

    Comparison of Limulus Amebocyte Lysate Test Methods for Endotoxin Measurement in Protein Solutions. J. Pharm. Biomed. Anal. 2013, 80, 180–185.

    OpenUrlCrossRefPubMed
14. 14.↵
    1. Bolden J.,
    2. Smith K.

    Application of Recombinant Factor C Reagent for the Detection of Bacterial Endotoxins in Pharmaceutical Products. PDA J. Pharm. Sci. Technol. 2017, 71 (5), 405–412.

    OpenUrlAbstract/FREE Full Text
15. 15.↵
    1. Carmichael R. H.,
    2. Botton M. L.,
    3. Shin P. K. S.,
    4. Cheung S. G.

    Changing Global Perspectives on Horseshoe Crab Biology, Conservation and Management; Carmichael R. H., Botton M. L., Shin P. K. S., Cheung S. G., Eds.; Springer International Publishing: Switzerland, 2015; p 599.
16. 16.↵
    1. Carmichael R. H.,
    2. Botton M. L.,
    3. Shin P. K. S.,
    4. Cheung S. G.

    1. Botton M. L.,
    2. Carmichael R. H.,
    3. Shin P. K. S.,
    4. Cheung S. G.

    Emerging Issues in Horseshoe Crab Conservation: A Perspective from the IUCN Species Specialist Group. In Changing Global Perspectives on Horseshoe Crab Biology, Conservation and Management; Carmichael R. H., Botton M. L., Shin P. K. S., Cheung S. G., Eds.; Springer International Publishing: Switzerland, 2015; pp 369–381.
17. 17.↵
    1. Maloney T.,
    2. Phelan R.,
    3. Simmons N.

    Saving the Horseshoe Crab: A Synthetic Alternative to Horseshoe Crab Blood for Endotoxin Detection. 2018, e26922v1. PeerJ Preprints. https://peerj.com/preprints/26922/ (accessed February 15, 2019).
18. 18.↵
    European Union Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the Protection of Animals Used for Scientific Purposes. OJEU L 276/33, 2019. EUR-Lex Web site. https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=celex%3A32010L0063 (accessed February 15, 2019).
19. 19.↵
    U.S. Pharmacopeial Convention, Process Revision: <1085> Guidelines on the Endotoxins Test. Pharmacopeial Forum [Online] 2018, 44 (4). PF Online Web site. www.usppf.com/pf/pub/data/v444/CHA_IPR_444_c1085.xml (accessed June 8, 2020).
20. 20.↵
    Council of Europe, Guidelines for Using the Test for Bacterial Endotoxins, Chapter 5.1.10. In European Pharmacopoeia (Ph. Eur.), 9th Edition, Council of Europe: Strasbourg, France, 2016.
21. 21.↵
    1. Dawson M.

    Changes in European Endotoxin Testing Regulations and Guidance, 2019. Associates of Cape Cod Incorporated Web site. http://www.acciusa.com/pdfs/whitepapers/EuropeanPolicy_n_Guideline-PR17-012.pdf (accessed February 15, 2019).
22. 22.↵
    European Pharmacopoeia (Ph. Eur.), Chapter 5.1.6, Alternative Methods for Control of Microbiological Quality, 9th Edition, Council of Europe: Strasbourg, France, 2016.
23. 23.↵
    U.S. Pharmacopeial Convention, General Chapter <1225> Validation of Compendial Procedures. Herbal Medicines Compendium Web site. https://hmc.usp.org/sites/default/files/documents/HMC/GCs-Pdfs/c1225_1SUSP40.pdf (accessed April 25, 2019).
24. 24.↵
    U.S. Pharmacopeial Convention, General Notices and Requirements: Applying to Standards, Tests, Assays, and Other Specifications of the United States Pharmacopeia. Elsmar Cove Web site. https://elsmar.com/elsmarqualityforum/attachments/usp34-nf29general-notices-pdf.17376/ (accessed February 15, 2019).
25. 25.↵
    Package Insert ENDOZYME® II. bioMérieux Industry Web site. http://www.hyglos.de/fileadmin/media/Products/Endotoxin_detection/PDF/Package_Insert_200254_V1_0_en_809030_EndoZyme_II.pdf (accessed February 15, 2019).
26. 26.↵
    Package Insert ENDOLISA. bioMérieux Industry Web site. http://www.hyglos.de/fileadmin/media/Package_Insert_606168_V2_0_en_60903_3_EndoLISA.pdf (accessed February 15, 2019).
27. 27.↵
    Endosafe®-MCS™ User's Guide for Endotoxin (LAL) Testing. BioBit Web site. http://www.biobit.ro/produse/documente/qc_mm_r_mcs_users_guide.pdf (accessed February 15, 2019).
28. 28.↵
    Package Insert Limulus Amebocyte Lysate (LAL) Kinetic-QCL. Lonza Web site. www.lonzabio.jp/products/endotoxin/pdf/00190169_en.pdf (accessed February 15, 2019).
29. 29.↵
    1. Bolden J. S.,
    2. Warburton R. E.,
    3. Phelan R.,
    4. Murphy M.,
    5. Smith K. R.,
    6. De Felippis M. R.,
    7. Chen D.

    Endotoxin Recovery Using Limulus Amebocyte Lysate (LAL) Assay. Biologicals 2016, 44 (5), 434–440.

    OpenUrl
30. 30.↵
    1. Nalepka J. L.,
    2. Greenfield E. M.

    Detection of Bacterial Endotoxin in Human Tissues. Biotechniques 2004, 37 (3), 413–417.

    OpenUrlPubMed
31. 31.↵
    1. Iwanaga S.,
    2. Kawabata S.,
    3. Muta T.

    New Types of Clotting Factors and Defense Molecules Found in Horseshoe Crab Hemolymph: Their Structures and Functions. J. Biochem. 1998, 123 (1), 1–15.

    OpenUrlCrossRefPubMedWeb of Science
32. 32.↵
    1. Roslansky P. F.,
    2. Novitsky T. J.

    Sensitivity of Limulus Amebocyte Lysate (LAL) to LAL-Reactive Glucans. J. Clin. Microbiol. 1991, 29 (11), 2477–2483.

    OpenUrlAbstract/FREE Full Text
33. 33.↵
    1. Tsuchiya M.,
    2. Takaoka A.,
    3. Tokioka N.,
    4. Matsuura S.

    Development of an Endotoxin-Specific Limulus Amebocyte Lysate Test Blocking Beta-Glucan-Mediated Pathway by Carboxymethylated Curdlan and Its Application. Nippon Saikingaku Zasshi 1990, 45 (6), 903–911.

    OpenUrlPubMed
34. 34.↵
    1. Tanaka S.,
    2. Aketagawa J.,
    3. Ohki M.,
    4. Takahashi S.,
    5. Tamura H.,
    6. Shibata Y.

    Horseshoe Crab Amebocyte Lysate Factor G Activation Inhibitor. U.S. Patent 5,155,032A, Oct 13, 1992. https://patents.google.com/patent/US5155032A/en (accessed November 4, 2019).
35. 35.↵
    1. Loverock B.,
    2. Simon B.,
    3. Burgenson A.,
    4. Baines A.

    A Recombinant Factor C Procedure for the Detection of Gram-Negative Bacterial Endotoxin. Pharmacopeial Forum 2010, 36 (1), 321–329.

    OpenUrl
36. 36.↵
    1. Fenwick N.,
    2. Griffin G.,
    3. Gauthier C.

    The Welfare of Animals Used in Science: How the “Three Rs” Ethic Guides Improvements. Can. Vet. J. 2009, 50 (5), 523–530.

    OpenUrlPubMed
37. 37.↵
    Council of Europe, Substitution of In Vivo Methods by In Vitro Methods for the Quality Control of Vaccines, Chapter 5.2.14. In European Pharmacopoeia (Ph. Eur.), 9th Edition, Council of Europe: Strasbourg, France, 2016.
38. 38.↵
    Outcome of the 160th Session of the European Pharmacopoeia Commission, 2018. EDQM Web site. https://www.edqm.eu/sites/default/files/pressrelease-pheur-160session-march2018.pdf (accessed February 15, 2019).
39. 39.↵
    Future of Endotoxins and Pyrogen Testing: Reference Standards and Procedures, Rockville, MD, June 10–11, 2019. USP Web site. http://www.usp.org/events-training/workshops/future-of-endotoxins-and-pyrogen-testing (accessed February 15, 2019).