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

References

1.↵
1. Ding J. L.,
2. Bow H
. Cloned factor C cDNA of the Singapore Horseshoe Crab, Carcinoscorpius rotundicauda and purification of Factor C proenzyme. U.S. Patent 5712144A, June 2, 1995.
2.↵
1. Tamura H.
The Road to Next Generation LAL Technology. EC Bacteriol. Virol. Res. 2016, ECO.01: 04–05. https://www.ecronicon.com/eco16/pdf/ECBVR-01-ECO-03.pdf (accessed May 28, 2020).
3.↵
1. Alwis K. U.,
2. Milton D. K.
Recombinant Factor C Assay for Measuring Endotoxin in House Dust: Comparison with LAL, and (1→3)-β D-Glucans. Am. J. Ind. Med. 2006, 49 (4), 296–300.
OpenUrl CrossRef PubMed Web of Science
4.↵
1. Thorne P. S.,
2. Perry S. S.,
3. Saito R.,
4. O’Shaughnessy P. T.,
5. Mehaffy J.,
6. Metwali N.,
7. Keefe T.,
8. Donham K. J.,
9. Reynolds S. J.
Evaluation of the Limulus Amebocyte Lysate and Recombinant Factor C Assays for Assessment of Airborne Endotoxin. Appl. Environ. Microbiol. 2010, 76 (15), 4988–4995.
OpenUrl Abstract/FREE Full Text
5.↵
1. McKenzie J. H.,
2. Alwis K. U.,
3. Sordillo J. E.,
4. Kalluri K. S.,
5. Milton D. K.
Evaluation of Lot-to-Lot Repeatability and Effect of Assay Media Choice in the Recombinant Factor C Assay. J. Environ. Monit. 2011, 13 (6), 1739–1745.
OpenUrl CrossRef PubMed
6.↵
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.
OpenUrl CrossRef PubMed
7.↵
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.
OpenUrl Abstract/FREE Full Text
8.↵
1. Kikuchi Y.,
2. Hashima Y.,
3. Fukui C.,
4. Murai T.,
5. Nakagawa Y.,
6. Ebisawa A.,
7. Matsumura K.,
8. Ouchi K.,
9. Oda T.,
10. Mukai M.,
11. Masuda T.,
12. Katto Y.,
13. Takasuga Y.,
14. Takaoka A.
Collaborative Study on the Bacterial Endotoxins Test Using Recombinant Factor C-Based Procedure for Detection of Lipopolysaccharides Part 1. Pharm. Med. Device Regul. Sci. 2017, 48 (4), 252–260.
OpenUrl
9.↵
1. Kikuchi Y.,
2. Hashima Y.,
3. Fukui C.,
4. Nakagawa Y.,
5. Ebisawa A.,
6. Morioka T.,
7. Matsumura K.,
8. Ouchi K.,
9. Uchida K.,
10. Martinez O. K.,
11. Oda T.,
12. Mukai M.,
13. Masuda T.,
14. Tsukihashi Y.,
15. Takasuga Y.,
16. Takaoka A.
Collaborative Study on the Bacterial Endotoxins Test Using Recombinant Factor C-Based Procedure for Detection of Lipopolysaccharides Part 2. Pharm. Med. Device Regul. Sci. 2018, 49, 708–718.
OpenUrl
10.↵
1. Kaur R.,
2. Sharma M.,
3. Ji D.,
4. Xu M.,
5. Agyei D.
Structural Features, Modification, and Functionalities of Beta-Glucan. Fibers 2020, 8 (1), 1–29.
OpenUrl CrossRef
11.↵
1. Schwarz H.,
2. Schmittner M.,
3. Duschl A.,
4. Horejs-Hoeck J.
Residual Endotoxin Contaminations in Recombinant Proteins Are Sufficient to Activate Human CD1c+ Dendritic Cells. PLoS One 2014, 9 (12), e113840.
OpenUrl CrossRef PubMed
12.↵
1. Schwarz H.,
2. Gornicec J.,
3. Neuper T.,
4. Parigiani M. A.,
5. Wallner M.,
6. Duschl A.,
7. Horejs-Hoeck J.
Biological Activity of Masked Endotoxin. Sci. Rep. 2017, 7 (1), 44750.
OpenUrl
13.↵
Parenteral Drug Association Inc. Technical Report No. 82: Low Endotoxin Recovery; Bethesda, MD, 2019. https://www.pda.org/bookstore/pda-bookstore (accessed May 28, 2020).
14.↵
1. Loverock B.,
2. Simon B.,
3. Burgenson A.,
4. Baines A.
Stimuli to the Revision Process: A Recombinant Factor C Procedure for the Detection of Gram-Negative Bacterial Endotoxin. Pharmacopeial Forum 2010, 36 (1), 321–329. http://www.usppf.com/ (accessed May 28, 2020).
OpenUrl
15.↵
1. Abate W.,
2. Sattar A. A.,
3. Liu J.,
4. Conway M. E.,
5. Jackson S. K.
Evaluation of Recombinant Factor C Assay for the Detection of Divergent Lipopolysaccharide Structural Species and Comparison with Limulus Amebocyte Lysate-Based Assays and a Human Monocyte Activity Assay. J. Med. Microbiol. 2017, 66 (7), 888–897.
OpenUrl
16.↵
1. Bolden J.,
2. Knight M.,
3. Stockman S.,
4. Omokoko B.
Results of a Harmonized Endotoxin Recovery Study Protocol Evaluation by 14 BioPhorum Operations Group (BPOG) Member Companies. Biologicals 2017, 48, 74–81.
OpenUrl
17.↵
1. Piehler M.,
2. Roeder R.,
3. Blessing S.,
4. Reich J.
Comparison of LAL and rFC Assays—Participation in a Proficiency Test Program between 2014 and 2019. Microorganisms 2020, 8 (3), 418–411.
OpenUrl
18.↵
1. Muroi M.,
2. Ogura N.,
3. Mizumura H.,
4. Aketagawa J.,
5. Oda T.,
6. Tanamoto K.-I.
Application of a Recombinant Three-Factor Chromogenic Reagent, PyroSmart, for Bacterial Endotoxins Test Filed in the Pharmacopeias. Biol. Pharm. Bull. 2019, 42 (12), 2024–2037.
OpenUrl
19.↵
1. Marius M.,
2. Vacher F.,
3. 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.
OpenUrl Abstract/FREE Full Text
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, 2017. www.edqm.eu (accessed May 28, 2020).
21.↵
General Chapter <1085> Guidelines on the Endotoxin Test. Pharmacopeial Forum 2018, 44 (4). https://www.uspnf.com/notices/1085-guidelines-on-endotoxin-test (accessed May 28, 2020).
22.↵
U.S. Pharmacopeial Convention, General Chapter <85> Bacterial Endotoxins Test. In USP 41–NF 36. USP: Rockville, MD, 2018. www.usp.org (accessed May 28, 2020).
23.↵
Ministry of Health Labour and Welfare of Japan, Bacterial Endotoxins Test and alternative methods using recombinant protein-reagents for endotoxin assay. In The Japanese Pharmacopoeia, MHLW: Tokyo, 2019. https://www.pmda.go.jp/files/000231653.pdf (accessed May 28, 2020).
24.↵
U.S. Food and Drug Administration, Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, 2012. FDA Web site. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pyrogen-and-endotoxins-testing-questions-and-answers (accessed May 28, 2020).
25.↵
U.S. Pharmacopeial Convention, General Chapter <1225> Validation of Compendial Procedures. In USP 40—NF 35, USP: Rockville, MD, 2017. https://pdfs.semanticscholar.org/5b03/95b168eff40a79b267de263480db5020dd05.pdf (accessed May 28, 2020).

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Recombinant Factor C Validation--Simpler Than You Think!

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Keywords

[1] 1.↵
Ding J. L.,
Bow H
. Cloned factor C cDNA of the Singapore Horseshoe Crab, Carcinoscorpius rotundicauda and purification of Factor C proenzyme. U.S. Patent 5712144A, June 2, 1995.

[2] Ding J. L.,

[3] Bow H

[4] 2.↵
Tamura H.
The Road to Next Generation LAL Technology. EC Bacteriol. Virol. Res. 2016, ECO.01: 04–05. https://www.ecronicon.com/eco16/pdf/ECBVR-01-ECO-03.pdf (accessed May 28, 2020).

[5] Tamura H.

[6] 3.↵
Alwis K. U.,
Milton D. K.
Recombinant Factor C Assay for Measuring Endotoxin in House Dust: Comparison with LAL, and (1→3)-β D-Glucans. Am. J. Ind. Med. 2006, 49 (4), 296–300.
OpenUrl CrossRef PubMed Web of Science

[7] Alwis K. U.,

[8] Milton D. K.

[9] 4.↵
Thorne P. S.,
Perry S. S.,
Saito R.,
O’Shaughnessy P. T.,
Mehaffy J.,
Metwali N.,
Keefe T.,
Donham K. J.,
Reynolds S. J.
Evaluation of the Limulus Amebocyte Lysate and Recombinant Factor C Assays for Assessment of Airborne Endotoxin. Appl. Environ. Microbiol. 2010, 76 (15), 4988–4995.
OpenUrl Abstract/FREE Full Text

[10] Thorne P. S.,

[11] Perry S. S.,

[12] Saito R.,

[13] O’Shaughnessy P. T.,

[14] Mehaffy J.,

[15] Metwali N.,

[16] Keefe T.,

[17] Donham K. J.,

[18] Reynolds S. J.

[19] 5.↵
McKenzie J. H.,
Alwis K. U.,
Sordillo J. E.,
Kalluri K. S.,
Milton D. K.
Evaluation of Lot-to-Lot Repeatability and Effect of Assay Media Choice in the Recombinant Factor C Assay. J. Environ. Monit. 2011, 13 (6), 1739–1745.
OpenUrl CrossRef PubMed

[20] McKenzie J. H.,

[21] Alwis K. U.,

[22] Sordillo J. E.,

[23] Kalluri K. S.,

[24] Milton D. K.

[25] 6.↵
Chen L.,
Mozier N.
Comparison of Limulus Amebocyte Lysate Test Methods for Endotoxin Measurement in Protein Solutions. J. Pharm. Biomed. Anal. 2013, 80, 180–185.
OpenUrl CrossRef PubMed

[26] Chen L.,

[27] Mozier N.

[28] 7.↵
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.
OpenUrl Abstract/FREE Full Text

[29] Bolden J.,

[30] Smith K.

[31] 8.↵
Kikuchi Y.,
Hashima Y.,
Fukui C.,
Murai T.,
Nakagawa Y.,
Ebisawa A.,
Matsumura K.,
Ouchi K.,
Oda T.,
Mukai M.,
Masuda T.,
Katto Y.,
Takasuga Y.,
Takaoka A.
Collaborative Study on the Bacterial Endotoxins Test Using Recombinant Factor C-Based Procedure for Detection of Lipopolysaccharides Part 1. Pharm. Med. Device Regul. Sci. 2017, 48 (4), 252–260.
OpenUrl

[32] Kikuchi Y.,

[33] Hashima Y.,

[34] Fukui C.,

[35] Murai T.,

[36] Nakagawa Y.,

[37] Ebisawa A.,

[38] Matsumura K.,

[39] Ouchi K.,

[40] Oda T.,

[41] Mukai M.,

[42] Masuda T.,

[43] Katto Y.,

[44] Takasuga Y.,

[45] Takaoka A.

[46] 9.↵
Kikuchi Y.,
Hashima Y.,
Fukui C.,
Nakagawa Y.,
Ebisawa A.,
Morioka T.,
Matsumura K.,
Ouchi K.,
Uchida K.,
Martinez O. K.,
Oda T.,
Mukai M.,
Masuda T.,
Tsukihashi Y.,
Takasuga Y.,
Takaoka A.
Collaborative Study on the Bacterial Endotoxins Test Using Recombinant Factor C-Based Procedure for Detection of Lipopolysaccharides Part 2. Pharm. Med. Device Regul. Sci. 2018, 49, 708–718.
OpenUrl

[47] Kikuchi Y.,

[48] Hashima Y.,

[49] Fukui C.,

[50] Nakagawa Y.,

[51] Ebisawa A.,

[52] Morioka T.,

[53] Matsumura K.,

[54] Ouchi K.,

[55] Uchida K.,

[56] Martinez O. K.,

[57] Oda T.,

[58] Mukai M.,

[59] Masuda T.,

[60] Tsukihashi Y.,

[61] Takasuga Y.,

[62] Takaoka A.

[63] 10.↵
Kaur R.,
Sharma M.,
Ji D.,
Xu M.,
Agyei D.
Structural Features, Modification, and Functionalities of Beta-Glucan. Fibers 2020, 8 (1), 1–29.
OpenUrl CrossRef

[64] Kaur R.,

[65] Sharma M.,

[66] Ji D.,

[67] Xu M.,

[68] Agyei D.

[69] 11.↵
Schwarz H.,
Schmittner M.,
Duschl A.,
Horejs-Hoeck J.
Residual Endotoxin Contaminations in Recombinant Proteins Are Sufficient to Activate Human CD1c+ Dendritic Cells. PLoS One 2014, 9 (12), e113840.
OpenUrl CrossRef PubMed

[70] Schwarz H.,

[71] Schmittner M.,

[72] Duschl A.,

[73] Horejs-Hoeck J.

[74] 12.↵
Schwarz H.,
Gornicec J.,
Neuper T.,
Parigiani M. A.,
Wallner M.,
Duschl A.,
Horejs-Hoeck J.
Biological Activity of Masked Endotoxin. Sci. Rep. 2017, 7 (1), 44750.
OpenUrl

[75] Schwarz H.,

[76] Gornicec J.,

[77] Neuper T.,

[78] Parigiani M. A.,

[79] Wallner M.,

[80] Duschl A.,

[81] Horejs-Hoeck J.

[82] 13.↵
Parenteral Drug Association Inc. Technical Report No. 82: Low Endotoxin Recovery; Bethesda, MD, 2019. https://www.pda.org/bookstore/pda-bookstore (accessed May 28, 2020).

[83] 14.↵
Loverock B.,
Simon B.,
Burgenson A.,
Baines A.
Stimuli to the Revision Process: A Recombinant Factor C Procedure for the Detection of Gram-Negative Bacterial Endotoxin. Pharmacopeial Forum 2010, 36 (1), 321–329. http://www.usppf.com/ (accessed May 28, 2020).
OpenUrl

[84] Loverock B.,

[85] Simon B.,

[86] Burgenson A.,

[87] Baines A.

[88] 15.↵
Abate W.,
Sattar A. A.,
Liu J.,
Conway M. E.,
Jackson S. K.
Evaluation of Recombinant Factor C Assay for the Detection of Divergent Lipopolysaccharide Structural Species and Comparison with Limulus Amebocyte Lysate-Based Assays and a Human Monocyte Activity Assay. J. Med. Microbiol. 2017, 66 (7), 888–897.
OpenUrl

[89] Abate W.,

[90] Sattar A. A.,

[91] Liu J.,

[92] Conway M. E.,

[93] Jackson S. K.

[94] 16.↵
Bolden J.,
Knight M.,
Stockman S.,
Omokoko B.
Results of a Harmonized Endotoxin Recovery Study Protocol Evaluation by 14 BioPhorum Operations Group (BPOG) Member Companies. Biologicals 2017, 48, 74–81.
OpenUrl

[95] Bolden J.,

[96] Knight M.,

[97] Stockman S.,

[98] Omokoko B.

[99] 17.↵
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), 418–411.
OpenUrl

[100] Piehler M.,

[101] Roeder R.,

[102] Blessing S.,

[103] Reich J.

[104] 18.↵
Muroi M.,
Ogura N.,
Mizumura H.,
Aketagawa J.,
Oda T.,
Tanamoto K.-I.
Application of a Recombinant Three-Factor Chromogenic Reagent, PyroSmart, for Bacterial Endotoxins Test Filed in the Pharmacopeias. Biol. Pharm. Bull. 2019, 42 (12), 2024–2037.
OpenUrl

[105] Muroi M.,

[106] Ogura N.,

[107] Mizumura H.,

[108] Aketagawa J.,

[109] Oda T.,

[110] Tanamoto K.-I.

[111] 19.↵
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.
OpenUrl Abstract/FREE Full Text

[112] Marius M.,

[113] Vacher F.,

[114] Bonnevay T.

[115] 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, 2017. www.edqm.eu (accessed May 28, 2020).

[116] 21.↵
General Chapter <1085> Guidelines on the Endotoxin Test. Pharmacopeial Forum 2018, 44 (4). https://www.uspnf.com/notices/1085-guidelines-on-endotoxin-test (accessed May 28, 2020).

[117] 22.↵
U.S. Pharmacopeial Convention, General Chapter <85> Bacterial Endotoxins Test. In USP 41–NF 36. USP: Rockville, MD, 2018. www.usp.org (accessed May 28, 2020).

[118] 23.↵
Ministry of Health Labour and Welfare of Japan, Bacterial Endotoxins Test and alternative methods using recombinant protein-reagents for endotoxin assay. In The Japanese Pharmacopoeia, MHLW: Tokyo, 2019. https://www.pmda.go.jp/files/000231653.pdf (accessed May 28, 2020).

[119] 24.↵
U.S. Food and Drug Administration, Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers, 2012. FDA Web site. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pyrogen-and-endotoxins-testing-questions-and-answers (accessed May 28, 2020).

[120] 25.↵
U.S. Pharmacopeial Convention, General Chapter <1225> Validation of Compendial Procedures. In USP 40—NF 35, USP: Rockville, MD, 2017. https://pdfs.semanticscholar.org/5b03/95b168eff40a79b267de263480db5020dd05.pdf (accessed May 28, 2020).

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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

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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

References

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Author/Reviewer Information

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