Implementation of Plasma Fractionation in Biological Medicines Production
نویسندگان
چکیده
CONTEXT The major motivation for the preparation of the plasma derived biological medicine was the treatment of casualties from the Second World War. Due to the high expenses for preparation of plasma derived products, achievement of self-sufficiency in human plasma biotechnological industry is an important goal for developing countries. EVIDENCE ACQUISITION The complexity of the blood plasma was first revealed by the Nobel Prize laureate, Arne Tiselius and Theodor Svedberg, which resulted in the identification of thousands of plasma proteins. Among all these proteins, four of which are commercially important for production due to significant need of patients. These four products are: albumin, IgG, factor VIII, and Factor IX. The starting material for the production of biological drugs from plasma is natural which is different from synthetic starting material. So, the quality of plasma as starting material plays an important role in the quality of final product. Introducing new techniques for preparation of the biological drugs from human plasma has resulted in the improvements in purity of products, higher safety, and yield noticeably. Still, the backbone of the modern plasma fractionation technique is mainly based on cold ethanol fractionation of the human plasma that is almost the same as fractionation of crude oil, breaking it down into its components. The demand for IgG for treating immune deficiencies and coagulation factor VIII for hemophilia A determines how to design the plasma fractionation industry in terms of capacity. Nowadays, cold ethanol fractionation has followed by chromatographic methods, since they offer higher purity. In this review, we describe different methods of plasma fractionation such as cold ethanol fractionation, gel filtration, fractionation by salt, and fractionation by polyethylene glycol. There is no doubt that the four main products of human plasma are albumin, IgG, coagulation factor VIII, and IX, which their methods of separation from human plasma have been explained in this paper. CONCLUSIONS It can be concluded that plasma fractionation with ethanol at low temperature for the preparation of the main human plasma biological components including albumin, IgG, coagulation factors VIII, and IX is still the most widely used method at an industrial scale. Nowadays, this method is being used in combination with different chromatographic techniques in order to achieve a higher quality and the yield.
منابع مشابه
Implementation of Plasma Fractionation in Biological Medicines Production
Context: The major motivation for the preparation of the plasma derived biological medicine was the treatment of casualties from the Second World War. Due to the high expenses for preparation of plasma derived products, achievement of self-sufficiency in human plasma biotechnological industry is an important goal for developing countries.Evidence Acquisition: The complexity of the bloo...
متن کاملغیرفعالسازی پاتوژنها در داروهای بیولوژیکی مشتق از خون: مقاله مروری
One of the main sources of a wide range of biological products as starting material is the human blood. These biological human plasma derived medicines play essential role in prevention and treatment of a variety of life threatening diseases. Mention to the starting material of these medicines which is blood or in another word human plasma, possibility of contamination by blood borne viruses ca...
متن کاملWHO Recommendations for the production, control and regulation of human plasma for fractionation
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Human plasma derived drugs separation by fractionation of plasma with polyethylene glycol
Background: There are varieties of purification techniques for separation of human plasma proteins such as salting out, ion exchange chromatography, and ethanol fractionation. There are limitations for each method, for example in salting out method, the salt has to be removed in an additional step. Ion exchange chromatography is difficult for scaling up, and plasma fractionation is a time consu...
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