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1

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

Bolden J, Knutsen C, Levin J, Milne C, Morris T, Mozier N, Spreitzer I, von Wintzingerode F. Bolden J, et al. PDA J Pharm Sci Technol. 2020 Sep-Oct;74(5):602-611. doi: 10.5731/pdajpst.2020.012187. Epub 2020 Aug 14. PDA J Pharm Sci Technol. 2020. PMID: 32817324 Review.

2

Application of Recombinant Factor C Reagent for the Detection of Bacterial Endotoxins in Pharmaceutical Products.

Bolden J, Smith K. Bolden J, et al. PDA J Pharm Sci Technol. 2017 Sep-Oct;71(5):405-412. doi: 10.5731/pdajpst.2017.007849. Epub 2017 Jul 20. PDA J Pharm Sci Technol. 2017. PMID: 28733334

3

Saving the horseshoe crab: A synthetic alternative to horseshoe crab blood for endotoxin detection.

Maloney T, Phelan R, Simmons N. Maloney T, et al. PLoS Biol. 2018 Oct 12;16(10):e2006607. doi: 10.1371/journal.pbio.2006607. eCollection 2018 Oct. PLoS Biol. 2018. PMID: 30312293 Free PMC article. Review.

4

Endotoxin detection--from limulus amebocyte lysate to recombinant factor C.

Ding JL, Ho B. Ding JL, et al. Subcell Biochem. 2010;53:187-208. doi: 10.1007/978-90-481-9078-2_9. Subcell Biochem. 2010. PMID: 20593268

5

Evaluation of limulus amebocyte lysate and recombinant endotoxin alternative assays for an assessment of endotoxin detection specificity.

Dubczak J, Reid N, Tsuchiya M. Dubczak J, et al. Eur J Pharm Sci. 2021 Apr 1;159:105716. doi: 10.1016/j.ejps.2021.105716. Epub 2021 Jan 14. Eur J Pharm Sci. 2021. PMID: 33454378 Free article.

6

Genetic engineering approach to develop next-generation reagents for endotoxin quantification.

Mizumura H, Ogura N, Aketagawa J, Aizawa M, Kobayashi Y, Kawabata SI, Oda T. Mizumura H, et al. Innate Immun. 2017 Feb;23(2):136-146. doi: 10.1177/1753425916681074. Epub 2016 Dec 5. Innate Immun. 2017. PMID: 27913792 Free PMC article.

7

Recombinant factor C assay for measuring endotoxin in house dust: comparison with LAL, and (1 --> 3)-beta-D-glucans.

Alwis KU, Milton DK. Alwis KU, et al. Am J Ind Med. 2006 Apr;49(4):296-300. doi: 10.1002/ajim.20264. Am J Ind Med. 2006. PMID: 16550568

8

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

Marius M, Vacher F, Bonnevay T. Marius M, et al. PDA J Pharm Sci Technol. 2020 Jul-Aug;74(4):394-407. doi: 10.5731/pdajpst.2019.010389. Epub 2020 Mar 16. PDA J Pharm Sci Technol. 2020. PMID: 32179709

9

Evaluation of lot-to-lot repeatability and effect of assay media choice in the recombinant Factor C assay.

McKenzie JH, Alwis KU, Sordillo JE, Kalluri KS, Milton DK. McKenzie JH, et al. J Environ Monit. 2011 Jun;13(6):1739-45. doi: 10.1039/c1em10035a. Epub 2011 May 9. J Environ Monit. 2011. PMID: 21552635 Free PMC article.

10

Recombinant bacterial endotoxin testing: a proven solution.

Tindall B, Demircioglu D, Uhlig T. Tindall B, et al. Biotechniques. 2021 May;70(5):290-300. doi: 10.2144/btn-2020-0165. Epub 2021 May 6. Biotechniques. 2021. PMID: 33956506 Free article.

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