ОСОБЕННОСТИ КОНТРОЛЯ ПРЕПАРАТОВ АЛЬБУМИНА ЧЕЛОВЕКА НА СОДЕРЖАНИЕ БАКТЕРИАЛЬНЫХ ЭНДОТОКСИНОВ
Аннотация
Рассмотрена проблема определения бактериальных эндотоксинов в препаратах альбумина человека. Для повышения безопасности препаратов рекомендован вариант двойного контроля, включающий биологический контроль на кроликах, а так же определение бактериальных эндотоксинов методом ЛАЛ-теста. Описаны причины, обосновывающие необходимость двойного контроля препаратов альбумина человека на содержание пирогенов и бактериальных эндотоксинов, основной из которых является особая природа молекулы альбумина, обратимо связывающая большое количество соединений, в том числе эндотоксины. Изложены известные причины ложноположительных и ложноотрицательных реакций ЛАЛ-теста, а так же универсальный вариант пробоподготовки, включающий разведение, температурную обработку и использование специальных диспергирующих агентов.
Об авторах
Т. В. Кукунина
Филиал ФГУП «НПО «Микроген» в г. Уфа «Иммунопрепарат»
Россия
Россия
А. Г. Исрафилов
Филиал ФГУП «НПО «Микроген» в г. Уфа «Иммунопрепарат»
Россия
Россия
М. Л. Романенкова
Филиал ФГУП «НПО «Микроген» в г. Уфа «Иммунопрепарат»
Россия
Россия
Р. С. Гайнуллина
Филиал ФГУП «НПО «Микроген» в г. Уфа «Иммунопрепарат»
Россия
Россия
Л. Г. Федько
Филиал ФГУП «НПО «Микроген» в г. Уфа «Иммунопрепарат»
Россия
Россия
Список литературы
1. G. Yamey. Albumin industry launches global promotion // BMJ. 2000. V. 320(7234). P. 533.
2. T. Zhou et al. Review of the rational use and adverse reactions to human serum albumin in the People’s Republic of China // Patient Prefer Adherence. 2013. V. 7. P. 1207-1212.
3. A.C. Steere, M.K. Rifaat, E.B. Seligmann et al. Pyrogen reactions associated with the infusion of normal serum albumin (human) // Transfusion. 1978. V. 18 (1). P. 102-107.
4. M.E. Dawson. Interference with the LAL test and how to address it. Associates of Cape Cod, Inc., Woods Hole, Massachusetts // LAL Update. 2005. V. 22(3). P. 1-6.
5. Improved endotoxin detection in protein/peptide and antibody samples using EndoPrep™. EndoPrep™ Application notes - Rev 1 09-11-08 // BioDtech. 2008. P. 1-10. URL: http://www.endotox-in-test.com/endoprep-sample-treat-ment-proteins-antibodies-peptides/ (дата обращения 22.12.2017).
6. Chapter 2.6.8. Pyrogens // European pharmacopoeia 8.0. 2013.
7. Chapter №151>. Pyrogen Test // United States Pharmacopeia. 2011.
8. M.E. Weary. A short history of the Limulus amebocyte lysate (LAL) test // Endosafe Times. 2007. V. 13 (1). URL: http://www.biobit.ro/produse/documente/qc_mm_n_endosafe_times_august_2010.pdf (дата обращения 17.12.2017).
9. E.T. Rietschel, T. Kirikae, F.U. Scheda et al. Bacterial endotoxin: molecular relationships of structure to activity and function // FASEB J. 1994. V. 8. P. 217-225.
10. V. Liebers, T. Brüning, M. Raulf-Heimsoth. Occupational endotoxin-exposure and possible health effects on humans // Am J Ind Med. 2006. V. 49. P. 474-491.
11. E.S. Van Amersfoort, T.J.C. Van Berkel, J. Kuiper. Receptors, mediators, and mechanisms involved in bacterial sepsis and septic shock // Clin. Microbiol. Rev. 2003. V. 16. P. 379-414.
12. F.B. Bang. A bacterial diseases of Limulus polyphemus // Bull Johns Hopkins Hosp. 1956. V. 98. P. 325-351.
13. J. Levin, F.B. Bang. Clottable protein in Limulus: its localization and kinetics of its coagulation by endotoxin // Thromb Diath Haemorrh. 1968. V. 19. P. 186-197.
14. J. Levin, F.B. Bang. The role of endotoxin in the extracellular coagulation of Limulus blood // Bull Johns Hopkins Hosp. 1964. V. 115. P. 265-274.
15. J. Levin et al. History of the Limulus Lysate Test // Bacterial endotoxins: structure, biomedical significance, and detection with the Limulus Amebocyte Lysate Test. - N.Y.: Alan R. Liss, Inc., 1985. P. 3-28.
16. А.Г. Ситников, Л.А. Травина, В.А. Багирова. ЛАЛ-тест. Современные подходы к определению пирогенности. - М. 1997. 96 с.
17. Licensing of Limulus Amebocyte Lysate, Use as an Alternative for Rabbit Pyrogen Test. 42 FR 57749. November 4, 1977.
18. Guideline on Validation of the Limulus Amebocyte Lysate Test As an Endproduct Endotoxin Test for Human and Animal Parenteral Drugs // Biological Products and Medical Devices. U.S. FDA. December 1987/June 2011.
19. Chapter <85>. Bacterial Endotoxins Test // United States Pharmacopeia 36. United States Pharmacopeial Convention, Rockville, MD, 2012. 90 р.
20. Chapter <161>. Transfusion and Infusion Assemblies and Similar Medical Device // United States Pharmacopeia 36. 2012. 131 р.
21. ANSI/AAMI ST72:2011/(R)2016. Bacterial endotoxins - Test methods, routine monitoring, and alternatives to batch testing. Association for the Advancement of Medical Instrumentation, Arlington, VA, 2011.
22. 4. Test for bacterial endotoxins. Document QAS/11.452 FINAL / World Health Organization, July 2012. P. 1-13. URL: http://www.who.int/medicines/publications/pharmacopoeia/Bacterial-endotoxins_QAS11-452_FINAL_July12. pdf (дата обращения 10.12.2017).
23. 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. EMA/CHMP/ICH/529785/2010 European Medicines Agency, September 2010, pp. 1-10. URL: http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural._guideline/2012/12/WC500136403.pdf (дата обращения 10.12.2017).
24. M.E. Dawson. A wealth of options. Choosing an LAL test method. Associates of Cape Cod, Inc., Woods Hole, Massachusetts // LAL Update. 1995. V. 13 (3). P. 1-6.
25. R.L. Górny, J. Douwes, P. Versloot, D. Heederik, J. Dutkiewicz. Application of the classic Limulus test and the quantitative kinetic chromogenic LAL method for evaluation of endotoxin concentration in indoor air // Ann Agric Environ Med. 1999. V. 6. P. 45-51.
26. Lonza: Limulus Amebocyte Lysate (LAL) PYROGENT®-5000. Cat. № N383, N384, N588, N688. Lonza. - Walkersville. 2007.
27. S. Nakamura, T. Morita, S. Iwanaga, M. Niwa, K. Takahashi. A sensitive substrate for the clotting enzyme in horseshoe crab hemocytes // J Biochem. 1977. V. 81. P. 1567-1569.
28. Limulus Amebocyte Lysate CHROMO- LAL for the Detection and Quantitation of Gram-negative Bacterial Endotoxins (Lipopolysaccharides). Associates of Cape Cod, Inc. Cat. № C0031. ACC, Falmouth, 2007.
29. S. Iwanaga, T. Morita, T. Harada, S. Nakamura, M. Niwa, K. Takada, T. Kimura, S. Sakakibara. Chromogenic substrates for horseshoe crab clotting enzyme. Its application for the assay of bacterial endotoxins // Hemostasis 1978. V. 7. P. 183-188.
30. M.J. Devleeschouwer, M.F. Cornil, J. Dony. Studies on the sensitivity and specificity of the Limulus amebocyte lysate test and rabbit pyrogen assays // Appl Environ Microbiol. 1985. V. 50. P. 1509-1511.
31. Limulus Amebocyte Lysate (LAL) Kinetic-QCL. Cat. № 50-650. Cambrex, Walkersville, 2008.
32. Chapter 2.6.14. Bacterial endotoxins // European pharmacopoeia 8.0, 2013.
33. 01. Bacterial Endotoxins Test // Japanese pharmacopoeia XIV. Сhapter 6. Р. 20-23.
34. Test for Bacterial Endotoxin // Pharmacopoeia of the People's Republic of China, Volume III. Appendix XII. 2015. P. A120-A124.
35. ОФС.1.2.4.0006.15. Бактериальные эндотоксины // Государственная фармакопея Российской Федерации. XIII изд. 2015. URL: http://pharmacopoeia.ru/ofs-1-2-4-0006-15-bakterialnye-endotoksiny/ (дата обращения 10.12.2017).
36. ФС.3.3.2.0006.15. Альбумин человека // Государственная фармакопея Российской Федерации. XIII изд. 2015. URL: http://pharmacopoeia.ru/fs-3-3-2-0006-15-albumin-cheloveka/ (дата обращения 15.10.2017).
37. Human Albumin solution 01/2013:0255 // European pharmacopoeia 8.0. Сhapter 0255. 2013.
38. Monographs Human Albumin // Pharmacopoeia of the people’s republic of China. V. III. 2005. Р. 175-177.
39. Human albumin. 3.9. Pyrogen test // Minimum requirements for biological products. National institute of infectious diseases Japan. 2006. Р. 217-218.
40. J.F. Cooper, J. Levin, H.N. Wagner. Quantitative comparison of in vitro and in vivo methods for the detection of endotoxin // J. Lab. Clin. Med. 1971. V. 78. P. 138-148.
41. S.M. Wolff. Biological effects of bacterial endotoxins in man // J. Infect. Dis. 1973. V. 128s. P. 251-256.
42. Determination of the bacterial endotoxin in pharmaceutical raw material, finished products and water for injection (WFI) using lysate and control standard endotoxin and bacterial endotoxin test method validation. URL: https://www.pharmaguideline.com/2011/04/bacterial-endotoxin-test-bet-validation.html (дата обращения 22.12.2017).
43. Guidance for Industry. Pyrogen and Endotoxins Testing: Questions and Answers, FDA, June 2012. URL: http://www.fda.gov/Drugs/Guidance-Compliance-Regulatory-information/Guidances/ucm31471B.htm (дата обращения 22.12.2017).
44. Official Control Authority Batch Release of Human Albumin. Guideline for Human Albumin. Human Blood Derived Medical Products / Council Directive 2001/83/EC formerly 89/381/ EEC, amended by Directive 2004/27/EC, EDQM, 2012.
45. Technical Guide for the Elaboration and Use of Monographs on Human Plasma-derived Products // European Pharmacopoeia. EDQM, 2015.
46. Overview of Comments Received on the Guideline on the Replacement of Rabbit Pyrogen Testing by an Alternative Test for Plasma Derived Medical Products (EMEA/CHMP/BWP/452081/2007).
47. Endotoxins: Pyrogens, LAL Testing and Depyrogenation / Ed. by K.L. Williams. - Boca Raton: CRC Press, 2007. 440 p.
48. T.J. Joiner, P.F. Kraus, T.C. Kupiec. Comparison of endotoxin testing methods for pharmaceutical products // International Journal of Pharmaceutical Compounding. 2002. V. 6. №. 6. P. 408-409.
49. A. Gardi, G. Arpagaus. The Limulus Amebocyte lysate test, a useful tool for the control of plasma fractions // Develop. Biol. Standard. 1977. V. 34. P. 21-26.
50. H.D. Hochstein, E.G. Seligmann, R.B. Marquina, E. Rivera. Limulus Amebocyte lysate testing in normal serum albumin (human) // Develop. Biol. Standard. 1979. V. 44. P. 35-52.
51. J. Levin, P.A. Tomasulo, R.S. Oser. Detection of endotoxemia in human blood and demonstration of an inhibitor // J. Lab. Clin. Med. 1970. V. 75. P. 903-911.
52. R.C. Skames, N.Y. Ann. The inactivation of endotoxin after interaction with certain proteins of normal serum // Acad. Sci. 1966. V. 133. P. 644-662.
53. Guideline on the Replacement of Rabbit Pyrogen Testing by an Alternative Test for Plasma Derived Medicinal Products. Committee for Medicinal Products for Human Use. European Medicines Agency. Doc. Ref. EMEA/CHMP/BWP/452081/2007. - London. 2009.
54. S.A. David, P. Balaram, V.I. Mathan. Characterization of the interaction of lipid A and lipopolysaccharide with human serum albumin: implications for an endotoxin carrier function for albumin // Journal of Endotoxin Research. 1995. V. 2. № 2. P. 99-106.
55. R. Elin, S. Wolff. Nonspecificity of the Limulus Amebocyte Lysate test: Positive reactions with polynucleotides and proteins // J. Infect. Diseases. 1973. V. 128. P. 349-352.
56. P.F. Rolansky, T.J. Novitsky. Sensitivity of Limulus Amebocyte Lysate (LAL) to LAL-reactive glucans // J. Clinical microbiology. 1991. V. 29. P. 2477-2483.
57. A. Kakinuma, T. Asano, H. Torri, Y. Sugino. Gelation of Limulus amebocyte lysate by an antitumor (1→3)-β-D-glucan // Biochem. Biophys. Res. Commun. 1981. V. 101. P. 434-439.
58. А.В. Карякин. Отечественные препараты крови и проблемы соответствия международным требованиям // Гематология и трансфузиология. 2012. № 3. Приложение. C. 112-113.
59. Beta-G-Blocker Kit Cat. № N190. Lonza, Walkersville, 2013. URL: http://bio.lonza.com/uploads/tx_mwaxmarketingmaterial/Lonza_ManualsProductInstructions_B-G-Blocker_Product_Insert.pdf (дата обращения 15.12.2017).
60. T. Obayashi. Addition of perchloric acid to blood samples for colorimetric limulus test using chromogenic substrate: comparison with conventional procedures and clinical applications // J. Lab. Clin. Med. 1984. V. 104(3). P. 321-330.
61. O. Westphal, O. Luderitz, F. Blister. Extraction of bacteria with phenol/ water // Naturforsch. B: Anorg. Chem. Org. Chem. Biochem. Biophys. Biol. 1952. V. 7B. P. 148-155.
62. R.I. Roth, F.C. Levin, J. Levin. Optimization of detection of bacterial endotoxin in plasma with the Limulus test // J. Lab. Clin. Med. 1990. V. 116(2). P. 153-161.
63. J.A. Rudbach, K.C. Milner. Reaction of endotoxin and surfactants. III, Effect of sodium lauryl sulfate on the structure and pyrogenicity of endotoxin // Canadian J. of Microbiol. 1968. V. 14. P. 1173-1178.
64. K.J. Sweadner, M. Forte, L.L. Nelson. Filtration removal of endotoxins (pyrogens) in solution in different states of aggregation // J. Applied and Environmental Microbiology. 1977. P. 382-385.
65. Medical Devices and LAL Testing. Associates of Cape Cod, Inc. Hong Kong, 2008. URL: http://www.service.hkpc.org/bme2008/CPD_Activities/Powerpoint_LAL.pdf (дата обращения 15.12.2017).
66. Rapid Micro Methods PTS - LAL. Endosafe Products and sevices. Charles river laboratories. P. 1-36. URL: https://www.yumpu.com/en/document/view/31599122/rapid-micro-methods-pts-a-lal-cvg (дата обращения 22.12.2017).
67. Pyrosperse™ (dispersing agent). Cat. № N188. Lonza, Walkersville, 2014. URL: http://bio.lonza.com/uploads/tx_mwaxmarketingmaterial/Lonza_ManualsProductInstructions_PYROSPERSE_Product_Insert.pdf (дата обращения 15.12.2017).
68. Lonza Manuals Product Instructions. Serum Plasma Testing with PYROGENT-5000 and Kinetic-QCL Assays. Technical Tips. URL: http://www.phmb.com/campaigns/pharmabiotech/linkedin-qc-sst/qc-tech-tip-serum-plasma.aspx (дата обращения 22.12.2017).
69. Accurate Endotoxin Detection in Human Plasma With ESP™. Endotoxin Sample Preparation (ESP™) Kit // ESP™ Application Notes. BioDtech, Inc. 2014. Rev 2 11-13-14. P. 1-9. URL: http://biodtechinc.com/wp-content/uploads/2014/09/ESP™-Application-Note.pdf (дата обращения 17.12.2017).
70. Patent US № 8921063 B2. Enhancing endotoxin detection / M.G. Pepe, M.K. Champion.
Рецензия
Для цитирования:
Кукунина Т.В., Исрафилов А.Г., Романенкова М.Л., Гайнуллина Р.С., Федько Л.Г. ОСОБЕННОСТИ КОНТРОЛЯ ПРЕПАРАТОВ АЛЬБУМИНА ЧЕЛОВЕКА НА СОДЕРЖАНИЕ БАКТЕРИАЛЬНЫХ ЭНДОТОКСИНОВ. Разработка и регистрация лекарственных средств. 2018;(2):100-109.
For citation:
Kukunina T.V., Israfilov A.G., Romanenkova M.L., Gaynullina R.S., Fedko L.G. PECULIARITIES OF CONTROL OF HUMAN ALBUMIN DRUGS ON THE CONTENT OF BACTERIAL ENDOTOXINS. Drug development & registration. 2018;(2):100-109. (In Russ.)
Просмотров: 950
Послать статью по эл. почте 