Potency Test of Human Hepatitis B Immunoglobulin in Thailand
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Abstract
Background: The prevention or treatment for people without immunity who were close-contacted with hepatitis B infection is to apply human hepatitis B immunoglobulin (HBIG) immediately together with hepatitis B vaccine. The potency of human hepatitis B immunoglobulin expresses their competency to bind to Hepatitis B surface antigens. At present, there are five product brands that were approved by the Thai Food and Drug Administration. Three brands are distributed in Thailand, one is produced in the country and the other two are imported. Each manufacturer company uses different immunoassay methods to test the potency of HBIG according to European pharmacopoeia 9.0, whereas the Institute of Biological Products has no method of HBIG potency testing. Hence, study must be conducted for the potency test of HBIG products to be used as a standard method of testing products distributed in the country.
Objective: To prove that the testing method is suitable and can be used as a standard method for potency test on all HBIG products that are distributed in Thailand.
Methodology: This study selected a commercial test kits for quantitative determination of anti-HBs in serum or plasma with Enzyme-Linked Immunosorbent Assay (ELISA) technique which is validated by international standard. Then, the research used it to examine the potency of HBIG products that distributed in the country between 2016 and 2019 in using samples from three product brands including 15 lots of the production and compare the results with the test results of the manufacturers to prove that it can be used as a standard method.
Results: Using the commercial test kit to examine antibody to hepatitis B virus in serum or plasma of patients to test the potency by ELISA method in 15 lots of 3 product brands found that the test results were similar to those of the manufacturers; there were not statistically significant difference (p>0.05). The results met the requirements of the European Pharmacopeia 9.0 and specification of each licensed products in the country. The application of the commercial test kit can reduce the test preparation period and decrease a variation of substance providing. Moreover, using international standard substance reference on the World Health Organization and use the same dilution method as the samples yielded the test results more reliable.
Conclusions: The results indicate that the commercial test kit is suitable and able to be use as a standard method for potency determination in all products that distributed in Thailand.
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References
2. สำนักโรคติดต่อทั่วไป กรมควบคุมโรค กระทรวงสาธารณสุข. ตำราวัคซีนและการสร้างเสริมภูมิคุ้มกันโรค ปี 2556: บทที่ 7.2 วัคซีนป้องกันโรคไวรัสตับอักเสบบี (Hepatitis B vaccine: HB) [อินเทอร์เน็ต]. นนทบุรี: กรมควบคุมโรค; 2556 [เข้าถึงเมื่อ 15 ส.ค. 2562]. เข้าถึงได้จาก: http://e-lib.ddc.moph.go.th/pdf/material-25/material-25.pdf
3. Akay S, Karasu Z. Hepatitis B immune globulin and HBV-related liver transplantation. Expert Opinion on Biological Therapy 2008;8:1815-22. doi.org/10.1517/14712598.8.11.1815.
4. กองยา สำนักงานคณะกรรมการอาหารและยา กระทรวงสาธารณสุข. ระบบค้นหาข้อมูลผลิตภัณฑ์ยา[อินเทอร์เน็ต]. นนทบุรี: กองยา; 2559. [เข้าถึงเมื่อ 15 ส.ค. 2562]. เข้าถึงได้จาก: http://pertento.fda.moph.go.th/FDA_SEARCH_DRUG/SEARCH_DRUG/FRM_SEARCH_DRUG.aspx
5. Bio-Rad. Monolisa™ anti-Hbs plus: enzyme immunoassay (EIA) for the detection and level determination of antibody to hepatitis b surface antigen (anti-hbs) in human serum or plasma [Internet]. Marnes-la-Coquette: Bio-Rad. 2009. [cited 2019 Aug 12]; [17 screens]. Available from: http://www.bio-rad.com/webroot/web/pdf/inserts/CDG/en/883582_EN.pdf
6. National Institute for Biological Standards and Control. WHO international standard 2nd international standard for anti-hepatitis B surface antigen (anti-HBs) immunoglobulin, human [Internet]. Hertfordshire: Institute; 2008 [cited 2019 Aug 12]. Available from: https://www.nibsc.org/documents/ifu/07-164.pdf
7. BioTek Instruments. Gen5™ microplate reader and imager software. Vermont. 2011.
8. National Institute of Infectious Diseases. Biostatistics program (2006): how to use the statistical quality control program [CD-ROM]. Tokyo: Ministry of Health, Labour and Welfare; 2006.
9. กองยา สำนักงานคณะกรรมการอาหารและยา กระทรวงสาธารณสุข. ประกาศสำนักงานคณะกรรมการอาหารและยา เรื่อง กำหนดหลักเกณฑ์ และวิธีการขอรับหนังสือรับรองรุ่นการผลิตยาชีววัตถุ และกำหนดแบบคำขอ และแบบหนังสือรับรองรุ่นการผลิตยาชีววัตถุ [อินเทอร์เน็ต]. 2557. [เข้าถึงเมื่อ 17 ก.ย. 2562]. เข้าถึงได้จาก: http://www.fda.moph.go.th/sites/drug/Shared%20Documents/Law04-Notification-ThFDA/FDA-20140926.pdf
10. Bonanni P, Bruzzone BM, Ansaldi F, Lai P, Orione L, Fulgheri M, Icardi GC. Hepatitis B immunization and anti-HBs quantitation: comparative performance of thirteen commercial immunoassays. J Prev Med Hyg 1998;39:46-50.
11. Huzly D, Schenk T, Jilg W, Neumann-Haefelin D. Comparison of nine commercially available assays for quantification of antibody response to hepatitis virus surface antigen. J Clin Microbiol 2008(46):1298–306. doi. 10.1128/JCM.02430-07.
12. European Pharmacopoeia. Human hepatitis B immunoglobulin. 9th ed. Strasbourg: Council of Europe; 2017. p. 2684.
13. European Pharmacopoeia. Human hepatitis B immunoglobulin for intravenous administration. 9th ed. Strasbourg: Council of Europe; 2017. p. 2684.
14. European Pharmacopoeia. 2.7.1 Immunochemical. 9th ed. Strasbourg: Council of Europe; 2017. p. 239-40.
15. Ferguson M, Yu MW, Heath A. Calibration of the second international standard for hepatitis B immunoglobulin in an international collaborative study. Vox Sanguinis 2010(99):77–84. doi: 10.1111/j.1423-0410.2010.1314.x. PMID: 20202182.