การพัฒนาวิธีตรวจวิเคราะห์เอกลักษณ์และความบริสุทธิ์ของยาอะดาลิมูแมบโดยเทคนิคแคปิลลารีอิเล็กโทรโฟรีซีส -โซเดียมโดดีซิลซัลเฟต
Article Sidebar
Main Article Content
Article Details
อนุญาตภายใต้เงื่อนไข Creative Commons Attribution 4.0 International License.
เอกสารอ้างอิง
1. Ellis CR, Azmat CE. Adalimumab. In: StatPearls [Internet]. Treasure Island (FL): StatPearls; 2025 Jan [cited 2024 Jan 13]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557889
2. Mordor Intelligence Research & Advisory. Adalimumab drugs market size & share analysis—growth trends & forecasts (2024–2029) [Internet]. Mordor Intelligence; 2024 [cited 2024 Oct 18]. Available from: https://www.mordorintelligence.com/industry-reports/adalimumab-drugs-market
3. U.S. Food and Drug Administration. FDA approves Amjevita, a biosimilar to Humira [Internet]. Silver Spring (MD): FDA; 2020 [cited 2024 Nov 20]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-amjevita-biosimilar-humira
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilars of adalimumab [Internet]. Mol (BE): Pro Pharma Communications International; 2024 Mar 11 [cited 2023 Jan 20]. Available from: https://gabionline.net/biosimilars/general/Biosimilars-of-adalimumab
5. De Putte V, Salfeld J, Kaymakcalan Z. Adalimumab. In: Moreland LW, Emery P, editors. TNF inhibition in the treatment of rheumatoid arthritis. London: Martin Dunitz; 2003.
6. Wiesner R, Scheller C, Krebs F, Wätzig H, Oltmann-Norden I. A comparative study of CE-SDS, SDS-PAGE, and Simple Western: influences of sample preparation on molecular weight determination of proteins. Electrophoresis. 2021 Feb;42(3):206–18. doi: 10.1002/elps.202000199. Epub 2020 Nov 30. PMID: 33185281.
7. Li M, Yu C, Wang W, Wu G, Wang L. Interlaboratory method validation of capillary electrophoresis sodium dodecyl sulfate (CE-SDS) methodology for analysis of mAbs. Electrophoresis. 2021 Oct;42(19):1900–13. doi: 10.1002/elps.202000396. Epub 2021 Aug 6. PMID: 34240427.
8. De Griend S-van CE. CE-SDS method development, validation, and best practice—an overview. Electrophoresis. 2019 Oct;40(18–19):2361–74. doi: 10.1002/elps.201900094. Epub 2019 Jun 6. PMID: 31141192.
9. สำนักยา สำนักงานคณะกรรมการอาหารและยา. คู่มือและหลักเกณฑ์การขึ้นทะเบียนตำรับยาชีววัตถุคล้ายคลึง (Biosimilars) [อินเทอร์เน็ต]. กรุงเทพฯ: อักษรกราฟฟิคแอนด์ดีไซน์; 2561 [เข้าถึงเมื่อ 2021 ก.พ. 19]. เข้าถึงได้จาก: https://drug.fda.moph.go.th/media.php?id=509750409062129664&name=13%20Biosimilar.pdf
10. Duhamel L, Gu Y, Barnett G, Tao Y, Voronov S, Ding J, et al. Therapeutic protein purity and fragmented species characterization by capillary electrophoresis sodium dodecyl sulfate using systematic hybrid cleavage and forced degradation. Anal Bioanal Chem. 2019 Aug;411(24):5617–29. doi: 10.1007/s00216-019-01942-8. Epub 2019 Jun 18. PMID: 31214752.
11. United States Pharmacopoeia. General chapter, <129> Analytical procedures for recombinant therapeutic monoclonal antibodies [Internet]. MD: USP-NF; 2022 [cited 2023 Feb 15]. Available from: https://online.uspnf.com/uspnf/document/1_GUID-AEE677A4-5F8C-46B3-B949-D5D3DF112DB8_2_en-US
12. European Medicines Agency. ICH Topic Q2 (R1) validation of analytical procedures: text and methodology. CPMP/ICH/381/95 [Internet]. 1995 [cited 2022 Jul 19]. Available from: https://www.ema.europa.eu/en/documents/scientific-guideline/ich-q-2-r1-validation-analytical-procedures-text-methodology-step-5_en.pdf
13. Council of Europe. European Pharmacopoeia. Vol I. 11th ed. Strasbourg: Council of Europe; 2022.
14. United States Pharmacopoeia. <1053> Capillary electrophoresis [Internet]. MD: USP-NF; 2023 [cited 2023 Feb 15]. Available from: https://online.uspnf.com/uspnf/document/1_GUID-89EA57F1-8148-4707-BAD5-536BE8DCC4EE_3_en-US
15. Esterman AL, Katiyar A, Krishnamurthy G. Implementation of USP antibody standard for system suitability in capillary electrophoresis sodium dodecyl sulfate (CE-SDS) for release and stability methods. J Pharm Biomed Anal. 2016 Sep;128:447–54. doi: 10.1016/j.jpba.2016.06.006. Epub 2016 Jun 7. PMID: 27344634.
16. Lee N, Lee JJ, Yang H, Baek S, Kim S, Kim S, et al. Evaluation of similar quality attribute characteristics in SB5 and reference product of adalimumab. MAbs. 2019 Jan;11(1):129–44. doi: 10.1080/19420862.2018.1530920. Epub 2018 Oct 19. PMID: 30296198; PMCID: PMC6343792.
17. Zhang E, Xie L, Qin P, Lu L, Xu Y, Gao W, et al. Quality by Design-Based assessment for analytical similarity of adalimumab biosimilar HLX03 to Humira®. AAPS J. 2020 May;22(3):69. doi: 10.1208/s12248-020-00454-z. PMID: 32385732; PMCID: PMC7210234.
