Endotoxin Content Testing in Biological Products with Recombinant Factor C

Silveira RL, Andrade SS, Schmidt CA, Casali RG, Dalmora SL. Comparative evaluation of pyrogens tests in pharmaceutical products. Braz.J Microbiology 2004;35(1-2):48-53. doi: 10.1590/S1517-83822004000100007.

European Directorate for Quality of Medicine & Healthcare of the Council of Europe. European pharmacopoeia 10.0: bacterial endotoxins. Strasbourg: Council of Europe; 2019. p. 209-213.

European Directorate for Quality of Medicine & Healthcare of the Council of Europe. European pharmacopoeia 10.0: guidelines for using the test for bacterial endotoxins. Strasbourg: Council of Europe; 2019. p. 639-642.

U.S. Pharmacopoeia National Formulary. <85> Bacterial endotoxins test. In: USP43–NF38 [Internet]. 2012 [cited 2021 Mar 23]. Available from: https://www.usp.org/harmonization-standards/pdg/general-methods/bacterial-endotoxins

European Directorate for Quality of Medicine & Healthcare of the Council of Europe. European pharmacopoeia 10.3: Test for bacterial endotoxins using recombinant factor c. Strasbourg: Council of Europe; 2021. p. 4776-7.

Hartung T, Borel A, Schmitz G. Detecting the broad spectrum of pyrogens with the human whole-blood monocyte activation test [Internet]. NY: BioProcess International. 2016 [cited 2021 Mar 23]. 14(3):38-56. Available from: https://bioprocessintl.com/analytical/downstream-validation/detecting-the-broad-spectrum-of-pyrogens-with-the-human-whole-blood-monocyte-activation-test/

Sastalla I, Monack DM, Kubatzky KF. Bacterial exotoxins: how bacteria fight the immune system. Front. Immunology 2016;7:300. doi: 10.3389/fimmu.2016.00300.

Sandle T. Endotoxin and Pyrogen Testing. In pharmaceutical microbiology: essentials for quality assurance and quality control. New Delhi: Woodhead. 2015. p. 131-145.

Williams KL. Endotoxin detection and control in pharma, limulus, and mammalian systems. Springer: Cham; 2019. p. 95-155.

Albertus B, Lambertus GT. Endotoxin and the hypothalamo-pituitary-adrenal (HPA) axis. Journal of Endotoxin Research 2003;9(1):3-24. doi:10.1177/09680519030090010101.

Rangel-Frausto MS. The epidemiology of bacterial sepsis. Infect Dis Clin North Am 1999;13(2): 299-312. doi: 10.1016/s0891-5520(05)70076-3. PMID: 10340168.

Department of Health and Human Services. Guidance for industry pyrogen and endotoxins testing: questions and answers [Internet]. Washington DC: U.S. FDA; 2012 [cited 2021 Feb 13]. Available from: https://www.fda.gov/media/83477/download

European Medicines Agency. ICH guideline Q4B annex 14 to note for evaluation and recommendation of pharmacopoeial texts for use in the ICH regions on bacterial endotoxins tests – general chapter [Internet]. London: EMA; 2013 [cited 2021 Feb 13]. Available from: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/international-conference-harmonisation-technical-requirements-registration-pharmaceuticals-human-use_en.pdf

World Health Organization. 3.4 Test for bacterial endotoxins [Internet]. Geneva: WHO; 2012 [cited 2021 Feb 13]. Available from: https://www.who.int/medicines/publications/pharmacopoeia/Bacterial-endotoxins_QAS11-452_FINAL_July12.pdf

Dubczak J. Past, present, and future of endotoxin testing [Internet]. American Pharmaceutical Review; 2020 [cited 2021 Mar 23]; 23(7):40-43. Available from: https://www.americanpharmaceuticalreview.com/Featured-Articles/571720-Past-Present-and-Future-of-Endotoxin-Testing/

ฐิติพร ภาคภูมิพงศ์. การทดสอบสารไพโรเจน ในผลิตภัณฑ์ยาฉีดปราศจากเชื้อ. วารสารโลหิตวิทยาและเวชศาสตร์บริการโลหิต 2011;21(1):37-40.

Gorman R. Atlantic horseshoe crabs and endotoxin testing: perspectives on alternatives, sustainable methods, & the 3Rs (replacement, reduction and refinement). Front. Mar. Sci. 2020;7:833. doi: 10.3389/fmars.2020.582132.

Krisfalusi GJ, Ali W, Dellinger K, Robertson L. The role of horseshoe crabs in the biomedical industry and recent trends impacting species sustainability. Front. Mar. Sci. 2018;5:185. doi: 10.3389/fmars.2018.00185.

Maloney T, Phelan R, Simmons N. Saving the horseshoe crab: A synthetic alternative to horseshoe crab blood for endotoxin detection. PLoS Biol. 2018;16(10):1-15. doi: 10.1371/journal.pbio.2006607.

Madrigal AC. The blood harvest [Internet]. Washington DC; The Atlantic; 2014 [cited 2021 Feb 24]. Available from: https://shapeoflife.org/sites/default/files/global/the-blood-harvest-technology-the-atlantic.pdf

Kocek AR. The narrow edge: a tiny bird, an ancient crab, and an epic journey. The Condor: Ornithological Applications 2018;(120):247-248. doi: 10.1650/CONDOR-17-228.1.

Chesler C. Medical labs may be killing horseshoe crabs. Scientific American [Internet]. 2016 [cited 2021 Feb 24]. Available from: https://www.scientificamerican.com/article/medical-labs-may-be-killing-horseshoe-crabs/

Zhang S. The last days of the blue-blood harvest [Internet]. Washington DC: The Atlantic; 2018 [cited 2021 Feb 24]. Available from: https://www.theatlantic.com/science/archive/2018/05/blood-in-the-water/559229/

Deborah C. Inside the biomedical revolution to save horseshoe crabs and the shorebirds that need them [Internet]. NY: Audubon; 2018 [cited 2021 Feb 24]. Available from: https://www.audubon.org/magazine/summer-2018/inside-biomedical-revolution-save-horseshoe-crabs

Rebecca LA, Winsor HW, Christopher CC. Sub-lethal behavioral and physiological effects of the biomedical bleeding process on the American horseshoe crab, limulus polyphemus. Bio Bull 2013;225(3):137-151. doi: 10.1086/BBLv225n3p137.

Russell WMS, Burch RL. The principles of humane experimental technique [Internet]. London: Methuen; 1959 [cited 2021 Feb 28]. Available from: https://caat.jhsph.edu/principles/the-principles-of-humane-experimental-technique

The European Union. Directive2010/63/ EU of The european parliament and of the council of 22 September 2010 on the protection of animals used for scientific purposes. Journal of the European Union [Internet]. 2010 [cited 2021 Mar 18]. Available from: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:276:0033:0079:en:PDF

Ding JL, Ho B. A new era in pyrogen testing. Trends in Biotechnol 2001 Aug;19(8):277-81. doi: 10.1016/s0167-7799(01)01694-8. PMID: 11451451.

Ding J, Ho B. Cloned factor C CDNA of the Singapore horseshoe crab, carcinoscorpius rotundicauda and purification of factor C proenzyme [Internet]. US Patent; 1998 No. 5712144 . [cited 2021 Mar 18]. Available from: https://patentimages.storage.googleapis.com/c0/d7/95/290092910d8823/US5712144.pdf

Piehler M, Roeder R, Blessing S, Reich J. Comparison of LAL and rFC assays participation in a proficiency test program between 2014 and 2019. Microorganisms 2020;8(3):418. doi: 10.3390/microorganisms8030418. PMID: 32188126; PMCID: PMC7143553.

Bolden J. Recombinant factor C in endotoxin detection and control in pharma, limulus, and mammalian systems. Springer: Cham; 2019. doi: 10.1007/978-3-030-17148-3_13.

Ding JL, Ho B. Endotoxin detection–from limulus amebocyte lysate to recombinant factor C. Subcell Biochem 2010;53:187-208. doi: 10.1007/978-90-481-9078-2_9. PMID: 20593268.

Alwis KU, Milton DK. Recombinant factor C assay for measuring endotoxin in house dust: comparison with LAL, and (1-->3)-beta-D-glucans. Am J Ind Med 2006 Apr;49(4):296-300. doi: 10.1002/ajim.20264. PMID: 16550568.

Chen L, Mozier N. Comparison of limulus amebocyte lysate test methods for endotoxin measurement in protein solutions. J Pharm Biomed Anal 2013Jun; 80:180-5. doi: 10.1016/j.jpba.2013.03.011. Epub 2013 Mar 26. PMID: 23584077.

Bolden J, 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. doi: 10.5731/pdajpst.2017.007849. Epub 2017 Jul 20. PMID: 28733334.

Marius M, Vacher F, Bonnevay T. Comparison of LAL and recombinant factor C endotoxin testing assays in human vaccines with complex matrices. PDA J Pharm Sci Technol 2020;74(4):394-407. doi: 10.5731/pdajpst.2019.010389. Epub 2020 Mar 16. PMID: 32179709.

Marius M, Vacher, F, Bonnevay T. Comparison of bacterial endotoxin testing methods in purified pharmaceutical water matrices. Biologicals 2020 Sep;67:49-55. doi: 10.1016/j.biologicals.2020.07.001. Epub 2020 Aug 2. PMID: 32753293.

Dubczak J, Reid N, Tsuchiya M. Evaluation of limulus amebocyte lysate and recombinant endotoxin alternative assays for an assessment of endotoxin detection specificity. Eur J Pharm Sci 2021 Apr 1;159:105716. doi: 10.1016/j.ejps.2021.105716. Epub 2021 Jan 14.

Council of Europe. Recombinant factor C: new Ph. Eur. chapter available as of 1 July 2020 [Internet]. Strabourg: Council of Europe; 2020 [cited 2021 Mar 23] Available from: https://www.edqm.eu/en/news/recombinant-factor-c-new-ph-eur-chapter-available-1-july-2020

Bolden J, Knutsen C, Levin J, Milne C, Morris T, Mozier N, von Wintzingerode F. Currently available recombinant alternatives to horseshoe crab blood lysates: are they comparable for the detection of environmental bacterial endotoxins? a review. PDA J Pharm Sci Technol 2020;74(5):602-611. doi: 10.5731/pdajpst.2020.012187. Epub 2020 Aug 14. PMID: 32817324.

U.S. Pharmacopoeia National Formulary. USP provides guidelines for recombinant factor C (rFC) a non-animal-derived reagent critical to development of vaccines and other sterile pharmaceutical products [Internet]. MD: US Prarmacopeial Convention; 2020 [cited 2021 Mar 23] Available from: https://www.usp.org/news/rfc-horseshoe-crabs-statement

Loverock B, Simon B, Burgenson A, Baines A. A recombinant factor C procedure for the detection of gram-negative bacterial endotoxin. Pharmacopeial Forum 2010;36(1):321-329.

Pharmaceuticals and Medical Devices Agency. Japanese Pharmacopeia: bacterial endotoxins test and alternative methods using recombinant protein-reagents for endotoxin assay [Internet]. 2019 [cited 2021 Mar 23]. Available from: https://www.pmda.go.jp/files/000231653.pdf

European Directorate for Quality of Medicine & Healthcare of the Council of Europe. European Pharmacopoeia 10.0: 2.6.30 monocyte activation test. Strasbourg: Council of Europe; 2019. p. 233-39.