Classification and Manufacturing Model of Advanced Therapy Medicinal Products
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Oct 14, 2021
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kidpun P, Chalongsuk R. Classification and Manufacturing Model of Advanced Therapy Medicinal Products. TFDJ [Internet]. 2021 Oct. 14 [cited 2024 Apr. 26];28(3):4-9. Available from: https://he01.tci-thaijo.org/index.php/fdajournal/article/view/252462
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References
1. European Medicines Agency. Regulation (EC) No 1394/2007 of the European Parliament and of the Council [Internet]. Official Journal of the European Union. 2007 [cited 2019 May 9]. Available from: https://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2007:324:0121:0137:en:PDF
2. United State Food and Drug Administration. Regulating Biological Products [Internet]. Silver Spring MD: U.S. FDA; 2008 [cited 2019 May 9]. Available from: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products
3. Azuma K. Regulatory landscape of regenerative medicine in Japan. Current Stem Cell Rep 1 2015;1:118-28. doi: https://doi.org/10.1007/s4778-015-0012-6.
4. กระทรวงสาธารณสุข.ประกาศสำนักงานคณะกรรมการอาหารและยา เรื่อง แนวทางการขึ้นทะเบียนตำรับยาที่เป็นผลิตภัณฑ์การแพทย์ขั้นสูง ชนิดผลิตภัณฑ์เซลล์บำบัด. ราชกิจจานุเบกษา เล่มที่ 135, ตอนพิเศษ 302 ง (ลงวันที่ 28 พฤศจิกายน 2561).
5. Azmi B, Inglefield CJ, Lewis MP. Autologous cell therapy: current treatments and future prospects. Wounds 2009;21(9):234-42. PMID: 25903815.
6. Wang X, Riviere I. Clinical manufacturing of CAR T cells: foundation of a promising therapy. Mol Ther Oncolytics 2016;3:16015. doi: 10.1038/mto.2016.15.
7. Bonini C, Mondino A. Adoptive T-cell therapy for cancer: the era of engineered T cells. Eur J Immunol 2015;45(9):2457-69. doi: 10.1002/eji.201545552. PMID: 26202766.
8. June CH, O'Connor RS, Kawalekar OU, Ghassemi S, Milone MC. CAR T cell immunotherapy for human cancer. Science 2018;359:1361-5. doi: 10.1126/science.aar6711. PMID: 29567707.
9. Davila ML, Bouhassira DC, Park JH, Curran KJ, Smith EL, Pegram HJ, et al. Chimeric antigen receptors for the adoptive T cell therapy of hematologic malignancies. Int J Hematol 2014;99:361-71. PIMD: 24311149.
10. European Medicines Agency. Yescarta [Internet]. 2018 [cited 2019 Jun 10]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/yescarta
11. United State Food and Drug Administration. YESCARTA (axicabtagene ciloleucel) [Internet]. Silver Spring MD: U.S. FDA; 2018 [cited 2019 Jun 10]. Available from: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/yescarta-axicabtagene-ciloleucel
12. Gionet-Gonzales MA, Leach JK. Engineering principles for guiding spheroid function in the regeneration of bone, cartilage, and skin. Biomed Mater 2018;13(3):1-27. doi: 10.1088/1748-605X/aab0b3. PMID: 29460842.
13. European Medicines Agency. Maci: matrix applied characterized autologous cultured ahondrocytes [Internet]. Amsterdam: Agency; 2013 [cited 2019 Jun 10]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/maci
14. United State Food and Drug Administration. Maci: autologous cultured chondrocytes porcine collagen membrane [Internet]. Silver Spring MD: U.S. FDA; 2019 [cited 2019 Jun 10]. Available from: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/maci-autologous-cultured-chondrocytes-porcine-collagen-membrane
15. Zur S. ATMPs: how to successfully master challenges and foster the regulatory success rate?. Corpus 2016;18:132-39.
16. Hunsberger J, Harrysson O, Shirwaiker R, Starly B, Wysk R, Cohen P, et al. Manufacturing road map for tissue engineering and regenerative medicine technologies. Stem cells transl med 2015;4:130-5.
17. Karantalis V, Schulman IH, Balkan W, Hare JM. Allogeneic cell therapy: a new paradigm in therapeutics. Circ res 2015;116:12-5.
18. Wang K, Liu Y, Li J, Wang B, Bishop R, White C, et al. A multiscale simulation framework for the manufacturing facility and supply chain of autologous cell therapies. Cytotherapy 2019;21:1081-93.
19. Mark W Lowdell, Owen Bain. Supply chain management in the delivery of ATMPs for trials and as licensed medicines. Cell Gene Therapy Insights 2017;3:843-51.
20. Hourd P, Chandra A, Medcalf N, Williams DJ, Regulatory challenges for the manufacture and scale-out of autologous cell therapies. 2014 Mar 31. In: StemBook [Internet]. Cambridge (MA): Harvard Stem Cell Institute; 2008. doi: 10.3824/stembook.1.96.1. PIMD: 24851305.
2. United State Food and Drug Administration. Regulating Biological Products [Internet]. Silver Spring MD: U.S. FDA; 2008 [cited 2019 May 9]. Available from: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products
3. Azuma K. Regulatory landscape of regenerative medicine in Japan. Current Stem Cell Rep 1 2015;1:118-28. doi: https://doi.org/10.1007/s4778-015-0012-6.
4. กระทรวงสาธารณสุข.ประกาศสำนักงานคณะกรรมการอาหารและยา เรื่อง แนวทางการขึ้นทะเบียนตำรับยาที่เป็นผลิตภัณฑ์การแพทย์ขั้นสูง ชนิดผลิตภัณฑ์เซลล์บำบัด. ราชกิจจานุเบกษา เล่มที่ 135, ตอนพิเศษ 302 ง (ลงวันที่ 28 พฤศจิกายน 2561).
5. Azmi B, Inglefield CJ, Lewis MP. Autologous cell therapy: current treatments and future prospects. Wounds 2009;21(9):234-42. PMID: 25903815.
6. Wang X, Riviere I. Clinical manufacturing of CAR T cells: foundation of a promising therapy. Mol Ther Oncolytics 2016;3:16015. doi: 10.1038/mto.2016.15.
7. Bonini C, Mondino A. Adoptive T-cell therapy for cancer: the era of engineered T cells. Eur J Immunol 2015;45(9):2457-69. doi: 10.1002/eji.201545552. PMID: 26202766.
8. June CH, O'Connor RS, Kawalekar OU, Ghassemi S, Milone MC. CAR T cell immunotherapy for human cancer. Science 2018;359:1361-5. doi: 10.1126/science.aar6711. PMID: 29567707.
9. Davila ML, Bouhassira DC, Park JH, Curran KJ, Smith EL, Pegram HJ, et al. Chimeric antigen receptors for the adoptive T cell therapy of hematologic malignancies. Int J Hematol 2014;99:361-71. PIMD: 24311149.
10. European Medicines Agency. Yescarta [Internet]. 2018 [cited 2019 Jun 10]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/yescarta
11. United State Food and Drug Administration. YESCARTA (axicabtagene ciloleucel) [Internet]. Silver Spring MD: U.S. FDA; 2018 [cited 2019 Jun 10]. Available from: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/yescarta-axicabtagene-ciloleucel
12. Gionet-Gonzales MA, Leach JK. Engineering principles for guiding spheroid function in the regeneration of bone, cartilage, and skin. Biomed Mater 2018;13(3):1-27. doi: 10.1088/1748-605X/aab0b3. PMID: 29460842.
13. European Medicines Agency. Maci: matrix applied characterized autologous cultured ahondrocytes [Internet]. Amsterdam: Agency; 2013 [cited 2019 Jun 10]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/maci
14. United State Food and Drug Administration. Maci: autologous cultured chondrocytes porcine collagen membrane [Internet]. Silver Spring MD: U.S. FDA; 2019 [cited 2019 Jun 10]. Available from: https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/maci-autologous-cultured-chondrocytes-porcine-collagen-membrane
15. Zur S. ATMPs: how to successfully master challenges and foster the regulatory success rate?. Corpus 2016;18:132-39.
16. Hunsberger J, Harrysson O, Shirwaiker R, Starly B, Wysk R, Cohen P, et al. Manufacturing road map for tissue engineering and regenerative medicine technologies. Stem cells transl med 2015;4:130-5.
17. Karantalis V, Schulman IH, Balkan W, Hare JM. Allogeneic cell therapy: a new paradigm in therapeutics. Circ res 2015;116:12-5.
18. Wang K, Liu Y, Li J, Wang B, Bishop R, White C, et al. A multiscale simulation framework for the manufacturing facility and supply chain of autologous cell therapies. Cytotherapy 2019;21:1081-93.
19. Mark W Lowdell, Owen Bain. Supply chain management in the delivery of ATMPs for trials and as licensed medicines. Cell Gene Therapy Insights 2017;3:843-51.
20. Hourd P, Chandra A, Medcalf N, Williams DJ, Regulatory challenges for the manufacture and scale-out of autologous cell therapies. 2014 Mar 31. In: StemBook [Internet]. Cambridge (MA): Harvard Stem Cell Institute; 2008. doi: 10.3824/stembook.1.96.1. PIMD: 24851305.