Plasma Fractionation; Current Status

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Plasma Fractionation; Current Status

By Ahmed Waqas, Hafsah Muhammad Chishti, Usman Waheed, Department of Biochemistry, Quaid-i-Azam University, Islamabad

Blood is a specialized tissue divisible into a cellular part (RBCs, WBCs, Platelets) and a liquid part, Plasma which is a transporting medium for cells and a variety of substances vital to the human body. It is 91% water and contains a large variety of proteins including albumin, immunoglobulins, and coagulation proteins such as fibrinogen.

[1] Many of the proteins in plasma have important therapeutic uses because some individuals are not able to produce these proteins in adequate quantities and therefore need replacement therapies (depending on the extent of the deficiency).  Plasma Fractionation is the general process of separating the various components of blood plasma.  Plasma can also be used for analytical purposes because it contains various biomarkers that can play a role in diagnosis of diseases and fractionation of plasma is a fundamental step to identify these biomarkers.

The fractionation process was developed by Edwin Joseph Cohn during the World War II where soldiers recovered at a faster rate because of the transfusions with albumin.  After the war, new developments gained momentum and in 1964, Judith Pool discovered a simple way to make cryoprecipitate that contained factor VIII. This discovery was a breakthrough for the treatment of haemophilia patients and since then, clinical use of these products has increased dramatically along with the advancement in plasma fractionation techniques. The new advancements include development of von Willebrand factor, factor XI, protein C, or alpha 1-antitrypsin concentrates for the substitutive therapy of congenital or acquired deficiencies [2] (such as haemophilia and alpha-1 antitrypsin deficiency).

The plasma fractionation process starts with recruitment and screening of blood donors. The screening process includes the review of the donor’s medical history, health practices and a comprehensive physical examination followed by industrial manufacturing of fractionated products. Unlike collected blood and blood components used for transfusion purposes, plasma used for the production of plasma protein therapies is subject to additional and complex manufacturing processes. Usually pooling of 10,000 to 50,000 donations is required for industrial processing but the major risk associated to plasma products is the transmission of blood-borne infectious agents. To ensure the safety all donations are screened for HBV, HCV and HIV-1/2. When collected for fractionation, the quality and safety of the plasma are intimately linked to the quality and safety of the manufactured plasma derivatives. It is estimated that 23–28 million litres of human plasma are fractionated each year throughout the world of which about 35% is obtained from whole blood donations and 65% by plasmaphaeresis (specialized procedure which separates blood into co.[3]

Currently more than 25 of the plasma proteins are commercially available to treat life-threatening diseases. Some of these medicines are already included in the WHO Model List of Essential Medicines indicating their importance from a global perspective. [4] The global market for plasma derived medicines is a dynamic market growing about 10% each year. However, it should not be forgotten that plasma protein therapies are expensive and considerably inaccessible to the patients living in countries with limited resources available to the health sector. [5] To give an example, about 80% of hemophiliacs living in developing countries have no access to sufficient amounts of coagulation factors. [6, 7]

Due to the unique nature of rare and serious diseases treated with plasma derived medicines, the fractionation programme should be given special priority in health care system that will ultimately leads to better patient care. Therefore, many countries have developed a national policy to improve and secure availability of safe and affordable plasma-derived medicines. It is also important to note that the price of plasma-derived medicines is a huge burden on health sector and plasma fractionation is an ideal project to reduce the cost of medicines fulfilling the demands of the country. In Norway, the fractionation project secured high yields of the fractionated products and the net income from the products produced was 140 € per litre plasma. [8] Iran with its unique technologies in the region exports 100,000 liters of plasma to Europe each year and imports plasma related medicines. [9] In South Asia, India is the first country to initiate the process of setting up the plasma fractionation facility which would have an initial capacity to fractionate 150,000 litres per annum of plasma.

Fractionation Projects across the world have revolutionized the approach to transfusion medicine but in Pakistan, it had not been given the attention and priority, it deserves in health care system. Recently the Ministry of Health has taken concrete steps to achieve safety and quality in blood transfusion services and launched a National Programme on Blood Transfusion. The Programme will follow a nationally coordinated approach that would revolutionalize the existing fragmented transfusion system. The programme, through technical and financial support from the Government of Germany envisages the establishment of regional centres acting as blood procurement centres and feeding the attached hospital blood banks. As the fractionation process needs a centralized blood transfusion system, it can be initiated from these regional centres which will automatically lead to substantial saving on national health resource and ensure continued self-sufficiency of plasma-derived medicines in Pakistan.

References:

  1. Brodniewicz-Proba, T. 1991. “Human Plasma Fractionation and the Impact of New Technologies on the Use and Quality of Plasma-derived Products”. Blood Reviews. Vol. 5. pp.245-257.
  2. Burnouf T. Plasma fractionation. Progress, problems and perspectives. Ann Pharm Fr. 1994; 52(3):124-36.
  3. Burnouf T. Modern plasma fractionation. Transfus Med Rev. 2007;21(2):101-17.
  4. Cheraghali AM, Abolghasemi H. Improving availability and affordability of plasma-derived medicines. Biologicals. 2010; 38(1):81-86
  5. Srivastava, A. Choice of factor concentrates for haemophilia: a developing world perspective. Haemophilia. 2001; 7: 117–122.
  6. Bird, A., Isarangkura, P., Almagro, D., Gonzaga, A. & Srivastava, A. Factor concentrates for haemophilia in the developing world. Haemophilia. 1998; 4: 481–485.
  7. Farrugia, A. (2004a) Product delivery in the developing world: options, opportunities and threats. Haemophilia, 10(Suppl. 4): 77–82.
  8. Flesland O, Seghatchian J, Solheim BG. The Norwegian plasma fractionation project – a 12 year clinical and economic success story. Transf Apher Sci 2003; 28:93–100.
  9. http://english.iribnews.ir/NewsBody.aspx?ID=9514
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