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Aghaie A. Plasma industry history at a glance. Sci J Iran Blood Transfus Organ 2022; 19 (1) :61-74
URL: http://bloodjournal.ir/article-1-1410-en.html
Plasma industry history at a glance
A. Aghaie *
Keywords: Plasma, Industry, Albumin
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   References:
  1. Curling J, Bryant C. The Plasma Fractionation Industry New Opportunities To Move Forward? BioProcess Int 2005; 18.
  2. Cohn EJ, Strong LE, Hughes WL, Mulford DJ, Ashworth JN, Melin M, et al. Preparation and Properties of Serum and Plasma Proteins. IV. A System for the Separation into Fractions of the Protein and Lipoprotein Components of Biological Tissues and Fluids. J Am Chem Soc 1946; 68(3): 459-75.
  3. Henderson LJ, Cohn EJ. The Equilibrium Between Acids and Bases in Sea Water. Proc Natl Acad Sci U S A 1916; 2(11): 618-22.
  4. Cohn EJ, Henderson LJ. The physical chemistry of bread making. Science 1918; 48(1247): 501-5.
  5. Cohn EJ. Studies in the physical chemistry of the proteins: i. The solubility of certain proteins at their isoelectric points. J Gen Physiol 1922; 4(6): 697-722.
  6. Cohn EJ, McMeekin TL, Edsall JT, Weare JH. Studies in the physical chemistry of amino acids, peptides and related substances. II. The solubility of α-amino acids in water and in alcohol water mixtures. J Am Chem Soc 1934; 56(11): 2270-82.
  7. Curling JM. Methods of plasma protein fractionation. J M Curling ed. London , United Kingdon: Academic Press INC; 1980. p. 148-50.
  8. Pennell R. Fractionation and Isolation of Purified Components by Precipitation Methods. 1960.
  9. Tanaka K, Shigueoka EM, Sawatani E, Dias GA, Arashiro F, Campos TC,  et al. Purification of human albumin by the combination of the method of Cohn with liquid chromatography. Braz J Med Biol Res 1998; 31(11): 1383-8.
  10. Lundblad RL. Biotechnology of plasma proteins. 2012.
  11. World Health Organization (WHO). Guidance on increasing supplies of plasma-derived medicinal products in low-and middle-income countries through fractionation of domestic plasma; 2021. p. 124-6.
  12. Robert P. Worldwide supply and demand of plasma and plasma-derived medicines. Iran J Blood Cancer 2011; 3(3): 111-20.
  13. Burnouf T. Modern plasma fractionation. Transfus Med Rev 2007; 21(2): 101-17.
  14. Burnouf T. Plasma proteins: unique biopharmaceuticals–unique economics. Pharmaceuticals policy and law. 2005; 7: 209-18.
  15. Brand A, De Angelis V, Vuk T, Garraud O, Lozano M, Politis D. Review of indications for immunoglobulin (IG) use: Narrowing the gap between supply and demand. Transfus Clin Biol 2021; 28(1): 96-122.
  16. Burnouf T, Epstein J, Faber JC. Recovered plasma for fractionation: call for quality standards to end wastage. Vox Sang 2020; 115(2): 213-4.
  17. Burnouf T, Faber JC, Radosevic M, Goubran H, Seghatchian J. Plasma fractionation in countries with limited infrastructure and low-/medium income: How to  move  forward? Transfus Apher Sci 2020; 59(1): 102715.
  18. Cheraghali AM, Aboofazeli R. Economical impact of plasma fractionation project in Iran on affordability of plasma-derived medicines. Transfus Med 2009; 19(6): 363-8.
  19. More A. Global plasma protein therapeutics market report 2021, Market report and insights, market value, cagr, Covid-19 impact, types, resources, market report rate, gross margin, share price, and forecast by 2021-2025. The Express Wire: 2021 Jun 3 2021.
  20. Finlayson JS. Therapeutic plasma fractions and plasma fractionation (prologue). Semin Thromb Hemost 1979; 6(1): 1-11.
  21. Hink JH, Jr., Hidalgo J, Seeberg VP, Johnson FF. Preparation and properties of a heat-treated human plasma protein fraction. Vox Sang 1957; 2(3): 174-86.
  22. Schneider W, Lefévre H, Fiedler H, McCarty LJ. An alternative method of large scale plasma fractionation for the isolation of serum albumin. Blut 1975; 30(2): 121-34.
  23. Robert P. Global plasma demand in 2015. Pharmaceuticals, Policy and Law 2009; 11: 359-67.
  24. De Silvestro G, Marson P, Breda A, De Angelis V. Plasma-derived industry and plasma-derived medicinal products in the Italian National Blood Transfusion Service. Transfus Apher Sci 2019; 58(5): 545-9.
  25. Bureau MR. Plasma Economics: How demand for plasma proteins affects plasma fractionation volumes marketing research bureau 2018 [10/07/2021]. Available from: https://marketingresearchbureau.com/plasma-industry/plasma-economics-concept-of-plasma-market-driver/.
  26. Cheraghali AM. Availability of blood components and plasma derived medicines in Iran. Transfus Apher Sci 2007; 37(1): 3-7.
  27. Farrugia A. International movement of plasma and plasma contracting. Dev Biol (Basel) 2005; 120: 85-96.
  28. Farrugia A, Evers T, Falcou PF, Burnouf T, Amorim L, Thomas S. Plasma fractionation issues. Biologicals  2009; 37(2): 88-93.
  29. Khorsand  Mohammad  Pour  H,  Banazadeh S, Aghaie A. Quality evaluation of human serum albumin prepared by heat denaturation in Iran: An experience for developing countries. Transfus Apher Sci 2014; 50(2): 219-24.
  30. Aghaie A, Pourfatollah A, Bathaie S, Moazzeni S, Pour H, Banazadeh S. Preparation, purification and virus inactivation of intravenous immunoglobulin from human plasma. Hum Antibodies 2010; 19(1): 1-6.
  31. Schlegel A, Immelmann A, Kempf C. Virus inactivation of plasma-derived proteins by pasteurization in the presence of guanidine hydrochloride. Transfusion 2001; 41(3): 382-9.
  32. Pamphilon D. Viral inactivation of fresh frozen plasma. British journal of haematology. 2000;109(4):680-93.
  33. Hoots WK. History of plasma-product safety. Transfus Med Rev 2001; 15(2 Suppl 1): 3-10.
  34. Trejo S, Hotta J, Lebing W, et al. Evaluation of virus and prion reduction in a new intravenous immunoglobulin manufacturing process. Vox Sang 2003; 84(3): 176-87.
  35. Velthove KJ, Over J, Abbink K, Janssen MP. Viral safety of human plasma–derived medicinal products: Impact of regulation requirements. Transfus Med Rev 2013; 27(3): 179-83.
  36. Fricke WA, Lamb MA. Viral safety of clotting factor concentrates. Semin Thromb Hemost 1993; 19(1): 54-61.
  37. Pierce GF, Lusher JM, Brownstein AP, Goldsmith JC, Kessler CM. The use of purified clotting factor concentrates in hemophilia: influence of viral safety, cost, and supply on therapy. JAMA 1989; 261(23): 3434-8.
  38. Parkkinen J, Rahola A, Von Bonsdorff L, Tölö H, Törmä E. A modified caprylic acid method for manufacturing immunoglobulin G from human plasma with high yield and efficient virus clearance. Vox Sang 2006; 90(2): 97-104.
  39. Remington K, Trejo S, Buczynski G, et al. Inactivation of West Nile virus, vaccinia virus and viral surrogates for relevant and emergent viral pathogens in plasma-derived products. Vox Sang 2004; 87(1): 10-8.
  40. Ragan I, Hartson L, Pidcoke H, Bowen R, Goodrich R. Pathogen reduction of SARS-CoV-2 virus in plasma and whole blood using riboflavin and UV light. PLoS
    One 2020; 15(5): e0233947.
  41. Tang JW, Shetty N, Lam TT, Hon KE. Emerging, novel, and known influenza virus infections in humans. Infect Dis Clin 2010; 24(3): 603-17.
  42. Roess AA, Galan A, Kitces E. Novel deer-associated parapoxvirus infection in deer hunters. N Engl J Med 2010; 363(27): 2621-7.
  43. Leiby DA. Transfusion-transmitted Babesia spp.: bull's-eye on Babesia microti. Clin Microbiol Rev 2011; 24(1): 14-28.
  44. Altizer S, Bartel R, Han BA. Animal migration and infectious disease risk. Science (New York, NY). 2011; 331(6015): 296-302.
  45. Burnouf T, Radosevich M. Reducing the risk of infection from plasma products: specific preventative strategies. Blood Rev 2000; 14(2): 94-110.
  46. Cai K, Gierman TM, Hotta J. Ensuring the biologic safety of plasma-derived therapeutic proteins. BioDrugs 2005; 19(2): 79-96.
  47. Aghaie A, Pourfathollah A, Bathaie S, Moazzeni S, Khorsand Mohammad Pour H, Banazadeh S. Structural study on immunoglobulin G solution after pasteurization with and without stabilizer. Transfus Med 2008; 18(1): 62-70.
  48. Aghaie A, Pourfatollah A, Bathaie S, Moazzeni S, Pour H, Sharifi Z. Inactivation of virus in intravenous immunoglobulin G using solvent/detergent treatment and pasteurization. Hum Antibodies 2008; 17(3-4): 79-84.
  49. Mantovani LG, Monzini M, Mannucci P, et al. Differences between patients’, physicians’ and pharmacists’ preferences for treatment products in haemophilia: a discrete choice experiment. Haemophilia 2005; 11(6): 589-97.
  50. Bodrogi J, Kaló Z. Principles of pharmacoeconomics and their impact on strategic imperatives of pharmaceutical research and development. Br J Pharmacol 2010; 159(7): 1367-73.
  51. Strengers PF. Plasma derived versus biotechnological manufactured medicine. Iran J Blood Cancer 2011; 3(3): 131-7.
  52. Cheraghali AM, Abolghasemi H. Improving availability and affordability of plasma-derived medicines. Biologicals 2010; 38(1): 81-6.












 



Sci J Iran Blood Transfus Organ 2022;19 (1): 61-74
 
Review Article
 
Plasma industry history at a glance

Aghaie A.1



1Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine, Tehran, Iran



Abstract
Background and Objectives
The plasma industry started during World War II with the need for Plasma Derived Medicinal Products (PDMP). About 30 major plasma products are now commercially available, the most important of which are albumin, coagulation factors and immunoglobulin. Demand for these products is still growing, and these products have become particularly important not only in the treatment of diseases but also in global trade. The article is a brief overview on the evolution of plasma industry over the past eighty years.

Materials and Methods
This review was done by searching for articles in Google Scholar, PubMed, Scopus databases, based on aspects of the evolution of the plasma industry, and the cost of producing plasma derivatives, from the beginning of this industry, from 1940 to 2021. Additionally, private sector entry and cost and benefit of viral deactivation processes in plasma industry was selected.

Results
The plasma industry has experienced tremendous progress over the years and faced many problems, and despite advances in biotechnology, this industry is a unique necessity in the health of human societies. The production of plasma-derived pharmaceutical products is a complex activity and involves several stages of operational units.

Conclusions 
There are many challenges and opportunities in the future of plasma industry. It seems that the emergence of new pathogens, the need for new PDMPs, and the potential to create new consumer markets, will be a challenge for plasma industry in the future. But the increasing demand can provide a good opportunity to change strategies and optimize consumption. The development of recombinant methods provides a good alternative to these products. In addition, the potential of using surplus plasma for local production provides an opportunity for developing countries.

Key words: Plasma, Industry, Albumin





Received:  23 May 2021
Accepted: 15 Aug 2021


Correspondence: Aghaie A., PhD of Immunology. Associate Professor of Blood Transfusion Research Center, High Institute for Research and Education in Transfusion Medicine.
P.O.Box: 14665-1157, Tehran, Iran. Tel: (+9821) 82052183; Fax: (+9821) 88601599
E-mail: aghaie.a@gmail.com
 
Type of Study: Review Article | Subject: Blood Transfusion
Published: 2022/03/30
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