سیر تکاملی صنعت راهبردی پلاسما در ایران
محورهای موضوعی :
مجله پلاسما و نشانگرهای زیستی
زهرا قاسمی
1
,
فاطمه بابایی
2
,
فاطمه پرسا
3
1 - دانشکده داروسازی، دانشگاه علوم پزشکی و خدمات بهداشتی درمانی شهید بهشتی، تهران،
2 - دانشکده داروسازی، دانشگاه علوم پزشکی و خدمات بهداشتی درمانی شهید بهشتی، تهران، ایران.
3 - دانشکده علوم دارویی، دانشگاه علوم پزشکی آزاد اسلامی تهران، تهران، ایران
تاریخ دریافت : 1402/06/05
تاریخ پذیرش : 1402/07/12
تاریخ انتشار : 1402/08/01
کلید واژه:
Plasma,
آلبومین,
albumin,
fractionation,
پلاسما,
پالایش,
پالایشگاه,
داروهای مشتق از پلاسما,
ایمونوگلوبین وریدی,
Plasma Derived Medicinal Products,
Intravenous Immunoglobulin,
Fractionator,
چکیده مقاله :
داروهای مشتق از پلاسما چندین دسته از درمان های بیولوژیک را تشکیل می دهند. این داروها برای درمان شرایط نادر، مزمن، شدید و تهدیدکننده زندگی، نظیر اختلالات خونریزی دهنده (مانند هموفیلی A و B)، بیماری همولیتیک جنین و نوزاد، عفونت های شدید، سوختگی و بیماری های کبدی و سایر بیماری های ناشی از نبود یا عدم عملکرد صحیح پروتئین های خاص مورد استفاده قرار می گیرند و کیفیت زندگی بیماران را ارتقا می بخشند. فرآیند تولید داروهای مشتق از پلاسما با جمع آوری پلاسمای انسانی از اهداکنندگان داوطلب سالم آغاز می شود. این مرحله اولیه، پیچیده بوده و توسط مقامات جهانی با دقت و حساسیت بالا نظارت می‌شود تا کیفیت و ایمنی محصول نهایی تولید شده و همچنین سلامت اهداکننده حفظ شود. میزان داروهای مشتق از پلاسمای تولید شده به در دسترس بودن ماده اولیه ی آن یعنی پلاسمای انسانی بستگی دارد از این رو داشتن پلاسمای کافی برای پالایش امری ضروری است. بنابراین در پیش گرفتن سیاست مناسب کشوری در خصوص اهدای پلاسما، ایجاد مراکز جمع آوری و همچنین افزایش آگاهی عموم از اهمیت اهدای پلاسما منجر به بهبود شرایط هر کشوری در خصوص تامین به موقع و کافی از این دسته داروها می‌شود. در این مطالعه ما بر آن شدیم تا نگاهی اجمالی به اهمیت این صنعت و وضعیت آن در کشور عزیزمان ایران داشته باشیم.
چکیده انگلیسی:
Plasma-derived Medicinal Products (PDMPs) are categorized as the biological treatments and used to treat rare, chronic, severe and life-threatening conditions, such as primary immunodeficiency syndrome, bleeding disorders (hemophilia A and B), hemolytic diseases, severe infections, burns and liver diseases, as well as other diseases that caused by absence or lack of proper functioning of certain proteins, and lastly result in recessive patient’s quality of life.The first step in the production of PDMPs, is to collect plasma from eligible and healthy donors. This initial stage is complex and is closely monitored by global authorities with high accuracy and sensitivity to ensure the quality and safety of the finished products, as well as the donor's health.The availability and accessibility of manufactured PDMPs strongly depends on the availability of human plasma as its raw material, meaning that sufficient volume of plasma for fractionation is crucial. Therefore, Adopting a suitable national health policy regarding plasma donation, establishing collection centers, and raising public awareness of the importance of plasma donation will improve nation’s culture for adequate supply of PDMPs. in this paper, we decided to provide a brief and complete oversight of the Iranian plasma industry and highlight the significance of covering the market with toll- manufactured products with Iranian plasma.
منابع و مأخذ:
WHO model list of essential medicines - 22nd list, 2021. Available from: https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2021.02
Strengers PFW, Klein HG. Plasma is a strategic resource. Transfusion. 2016;56(12):3133–7.
Hartmann J, Klein HG. Supply and demand for plasma-derived medicinal products - A critical reassessment amid the COVID-19 pandemic. Transfusion. 2020;60(11):2748–52.
Schmidt PJ. The plasma wars: a history. Transfusion [Internet]. 2012 May;52:2S-4S. Available from: https://onlinelibrary.wiley.com/doi/10.1111/j.1537-2995.2012.03689.x
European Medicines Agency. Guideline on plasma-derived medicinal products. Vol. 44, EMA Guideline. 2011. p. 1–33.
Farrugia A, Penrod J, Bult JM. The Ethics of Paid Plasma Donation: A Plea for Patient Centeredness. HEC Forum. 2015;27(4):417–29.
Farrugia A, Scaramuccia D. The dynamics of contract plasma fractionation. Biologicals [Internet]. 2017;46:159–67. Available from: http://dx.doi.org/10.1016/j.biologicals.2017.02.007
Structures MB. Guidance on increasing supplies of plasma-derived medicinal products in low- and middle-income countries through fractionation of domestic plasma. 2021.
Rosendaal FR, Smitt C, Varekamps I. Modern haemophilia treatment : medical improvements and quality of life. 1990;633–40.
N Engl J Med 1965. Production of high-potency concentrates of antihemophilic globulin in a closed-bag system. N Engl J Med. 1965;
Mercier Ythier J. The contested market of plasma. Transfus Clin Biol [Internet]. 2020;27(1):52–7. Available from: https://doi.org/10.1016/j.tracli.2019.10.003
Prevot J, Jolles S. Global immunoglobulin supply: Steaming towards the iceberg? Curr Opin Allergy Clin Immunol. 2020;20(6):557–64.
Guidelines on Assessing Donor Suitability for Blood Donation. World Heal Organ. 2012;1(5396):1497–1497.
Kluszczynski, T; Rohr, S; Ernst R. Key Economic and Value Considerations for Plasma-Derived Medicinal Products (PDMPs) in Europe. Ppta. 2020;
Burnouf T. An overview of plasma fractionation. Ann Blood. 2018;3:33–33.
Farrugia A, Penrod J, Bult JM. Payment, compensation and replacement - The ethics and motivation of blood and plasma donation. Vox Sang. 2010;99(3):202–11.
HealthCare ED for the Q of M&. Who Recommendations for the Production , Control and Regulation of human plasma for fractionation. Methods. 2005;(October):24–8.
Burnouf T. An overview of plasma fractionation. Ann Blood. 2018;3(June):33–33.
Grabowski H. Key economic and value considerations in the U.S. market for plasma protein therapies. 2018;(February).
Siegel J. The product: All intravenous immunoglobulins are not equivalent. Pharmacotherapy. 2005;25(11 II).
Burnouf T, Faber J, Radosevic M, Goubran H. Transfusion and Apheresis Science Plasma fractionation in countries with limited infrastructure and low- / medium income : How to move forward ? Transfus Apher Sci [Internet]. 2019;(xxxx):102715. Available from: https://doi.org/10.1016/j.transci.2019.102715
Robert P. “Plasma industry challenges and opportunities differences between the plasma and the pharmaceutical industries.” In: Barcelona: International Plasma Proteins Congress (IPPC). 2016.
Hotchko M. Current Market Landscape For Methodology And Immunoglobulins. In 2022.
Cheraghali M. Availability of blood components and plasma derived medicines in Iran. Transfus Apher Sci. 2007;37:3–7.
Biodarou Co. [Internet]. Available from: https://biodarou.com/
Darmanara Co. [Internet]. Available from: https://www.darmanara.com/
Afsaneh Aghaei. Plasma industry history at a glance. Sci J Iran Blood Transfus Organ. 2022;40:61–74.
Mohammadi S, Aghabozorg F, Balagholi S, Ferdowsi S, Sharifi S, Eshghi P. Source Plasma Donation: The Experience of the Iranian Blood Transfusion Organization. Int J Hematol Stem Cell Res [Internet]. 2022 Jul 24;16(3). Available from: https://publish.kne-publishing.com/index.php/IJHOSCR/article/view/10137
Maghsudlu M, Nasizadeh S. Iranian blood donors’ motivations and their influencing factors. Transfus Med. 2011;21(4):247–52.
WHO. Improving access to safe blood products through local production and technology transfer in blood establishments. 2015;
Robert PP. International Blood / Plasma News. 2002;19(11).
_||_
WHO model list of essential medicines - 22nd list, 2021. Available from: https://www.who.int/publications/i/item/WHO-MHP-HPS-EML-2021.02
Strengers PFW, Klein HG. Plasma is a strategic resource. Transfusion. 2016;56(12):3133–7.
Hartmann J, Klein HG. Supply and demand for plasma-derived medicinal products - A critical reassessment amid the COVID-19 pandemic. Transfusion. 2020;60(11):2748–52.
Schmidt PJ. The plasma wars: a history. Transfusion [Internet]. 2012 May;52:2S-4S. Available from: https://onlinelibrary.wiley.com/doi/10.1111/j.1537-2995.2012.03689.x
European Medicines Agency. Guideline on plasma-derived medicinal products. Vol. 44, EMA Guideline. 2011. p. 1–33.
Farrugia A, Penrod J, Bult JM. The Ethics of Paid Plasma Donation: A Plea for Patient Centeredness. HEC Forum. 2015;27(4):417–29.
Farrugia A, Scaramuccia D. The dynamics of contract plasma fractionation. Biologicals [Internet]. 2017;46:159–67. Available from: http://dx.doi.org/10.1016/j.biologicals.2017.02.007
Structures MB. Guidance on increasing supplies of plasma-derived medicinal products in low- and middle-income countries through fractionation of domestic plasma. 2021.
Rosendaal FR, Smitt C, Varekamps I. Modern haemophilia treatment : medical improvements and quality of life. 1990;633–40.
N Engl J Med 1965. Production of high-potency concentrates of antihemophilic globulin in a closed-bag system. N Engl J Med. 1965;
Mercier Ythier J. The contested market of plasma. Transfus Clin Biol [Internet]. 2020;27(1):52–7. Available from: https://doi.org/10.1016/j.tracli.2019.10.003
Prevot J, Jolles S. Global immunoglobulin supply: Steaming towards the iceberg? Curr Opin Allergy Clin Immunol. 2020;20(6):557–64.
Guidelines on Assessing Donor Suitability for Blood Donation. World Heal Organ. 2012;1(5396):1497–1497.
Kluszczynski, T; Rohr, S; Ernst R. Key Economic and Value Considerations for Plasma-Derived Medicinal Products (PDMPs) in Europe. Ppta. 2020;
Burnouf T. An overview of plasma fractionation. Ann Blood. 2018;3:33–33.
Farrugia A, Penrod J, Bult JM. Payment, compensation and replacement - The ethics and motivation of blood and plasma donation. Vox Sang. 2010;99(3):202–11.
HealthCare ED for the Q of M&. Who Recommendations for the Production , Control and Regulation of human plasma for fractionation. Methods. 2005;(October):24–8.
Burnouf T. An overview of plasma fractionation. Ann Blood. 2018;3(June):33–33.
Grabowski H. Key economic and value considerations in the U.S. market for plasma protein therapies. 2018;(February).
Siegel J. The product: All intravenous immunoglobulins are not equivalent. Pharmacotherapy. 2005;25(11 II).
Burnouf T, Faber J, Radosevic M, Goubran H. Transfusion and Apheresis Science Plasma fractionation in countries with limited infrastructure and low- / medium income : How to move forward ? Transfus Apher Sci [Internet]. 2019;(xxxx):102715. Available from: https://doi.org/10.1016/j.transci.2019.102715
Robert P. “Plasma industry challenges and opportunities differences between the plasma and the pharmaceutical industries.” In: Barcelona: International Plasma Proteins Congress (IPPC). 2016.
Hotchko M. Current Market Landscape For Methodology And Immunoglobulins. In 2022.
Cheraghali M. Availability of blood components and plasma derived medicines in Iran. Transfus Apher Sci. 2007;37:3–7.
Biodarou Co. [Internet]. Available from: https://biodarou.com/
Darmanara Co. [Internet]. Available from: https://www.darmanara.com/
Afsaneh Aghaei. Plasma industry history at a glance. Sci J Iran Blood Transfus Organ. 2022;40:61–74.
Mohammadi S, Aghabozorg F, Balagholi S, Ferdowsi S, Sharifi S, Eshghi P. Source Plasma Donation: The Experience of the Iranian Blood Transfusion Organization. Int J Hematol Stem Cell Res [Internet]. 2022 Jul 24;16(3). Available from: https://publish.kne-publishing.com/index.php/IJHOSCR/article/view/10137
Maghsudlu M, Nasizadeh S. Iranian blood donors’ motivations and their influencing factors. Transfus Med. 2011;21(4):247–52.
WHO. Improving access to safe blood products through local production and technology transfer in blood establishments. 2015;
Robert PP. International Blood / Plasma News. 2002;19(11).
