Introduction: The discussion of this topic hinges necessarily on the question “What is self-sufficiency?” It is our experience that the use of this term many times is used to satisfy political rather than clinical needs.According to the Economics Dictionary Self-sufficiency means: “the ability of a household or a country to exist on products produced by itself without the need to purchase supplies from elsewhere”[1] The question one might ask is whether it is advisable to create a state of national self-sufficiency for PLASMA protein therapies.

Introduction: The role of PLASMA-Derived Medicinal Products (PDMPs) in managing life-threatening diseases is remarkable. Human PLASMA as a raw material for PDMPs is obtained from volunteers through apheresis or whole blood collection. The global PDMPs market in 2021 shows an average annual growth rate of 7.4% since 1996 which is higher than the average annual pharmaceutical market growth rate. In line with WHO policies, Iran has improved its national voluntary non-remunerated donors (VNRD) program to supply the local PDMPs market. This study shows the 10-year Iran PDMPs market evolution to assess its self-sufficiency. Method: We conducted a cross-sectional study from 2012 to 2021 to assess the self-sufficiency rate of Iran’s PLASMA industry for PDMPs including Albumin, Immune globulins, and Antihemophilic Factors. In addition, we show the gap between market supply and demand to lighten the self-sufficiency future. Result: The annual growth rate of total collected PLASMA was 18.9% over 10 years in Iran from 2012 to 2021. Although the consumption rate of intravenous Immune globulins has increased from 777 kg to 2,108 Kg, due to a significant increase in local PLASMA production, its self-sufficiency rate increased from 53% to 93%.  Similarly, the demand rate for Albumin grew from 21% in 2012 to 90% in 2021. Discussion: Although local PLASMA production in Iran significantly provided PLASMA self-sufficiency as a raw material, local market demand for PDMPs is mainly supplied through contract fractionation with European fractionators.  Access to complete self-sufficiency in Iran needs increasing PLASMA production, as well as developing major local PLASMA fractionators.

Cultivated media for the growth of human blood cells are many, but the use of natural and less expensive materials is the most important to obtain the suitable growth for the cultivation of human lymphocytes. It needs a lot of materials that help in its development. Here, PLASMA is a very important growth factor for the growth of cells, which through its growth is useful in studying many natural and abnormal processes and interactions that occur in cells or studying the effect of many chemicals on cells through the examination of cell division so that it does not affect the nature of their chromosomes, and the results showed that the best concentration of chromosomes. Human PLASMA suitable for the growth of human blood cells is 20% and 10% PLASMA concentration which gave the highest cell division rate that could be obtained. There are no significant differences between PLASMA concerning the cell division index. As for the study of the chromosomal body, this indicator is important and is widely used in cytogenetic studies.

The Early Years of the PLASMA Industry: In the early 1940’s, Dr. E. Cohn discovered the PLASMA fractionation process in Boston (1). After it was found that albumin was an efficacious and safe drug, and could be produced in large quantities, several manufacturing plants were built in the United States. Pharmaceutical companies involved at the early stage of the fractionation industry included Parke Davis, which built a plant in Los Angeles (now operated by Grifols), Armour near Chicago, now operated by CSL Behring, Cutter in Berkeley, and Baxter in Glendale, near Los Angeles. Some public entities also built facilities to process human PLASMA, such as the Michigan Biological Laboratory. In Europe, fractionation plants were built in Germany (Behringwerke, part of the Hoechst pharmaceutical concern), Italy (Farma Biagini, Sclavo), France (Centre National de Transfusion Sanguine and Institut Merieux), Grifols in Spain, and the Swiss Red Cross Blood Transfusion Service in Switzerland (2).