“Go no Go” in plasma fractionation in the world's emerging economies: Still a question asked 70 years after the COHN process was developed!

Abstract

In the late 1980s, following the human immunodeficiency virus (HIV) epidemic and transfusion-transmitted infections from plasma-derived coagulation factor concentrates to hemophiliacs, many “advanced thinkers” claimed that plasma-derived products would be completely replaced by the year 2000 by safe recombinant products in most developed countries. However, things have not turned out that way, due to both the continual progress witnessed in plasma fractionation and viral-reduction technologies and technical difficulties still being encountered in developing more cost-effective non-immunogenic, fully active recombinant therapeutic proteins. Accordingly, plasma fractionation remains a reasonably healthy industry worldwide, with an ever-increasing volume of plasma fractionated each year to meet the demands for safe and effective plasma-derived medicines at the global level. While high-income countries currently have generally good access to a panel of plasma-derived and recombinant products, desperate shortages of fractionated plasma products remain in developing economies,and patients still have to be treated inadequately. The steady development of the collection of whole blood in developing economies, to gradually cover the recognized needs for red blood cell concentrates, generates an increasing volume of recovered plasma that is currently wasted. Incentives are therefore high for those countries to consider fractionating such plasma as a means of enhancing their supply of products to treat patients, thereby also decreasing the level of dependence on imported products. Challenges of local plasma fractionation in developing economies are high, in a context where the technological and regulatory sophistication of the plasma fractionation industry is often underestimated, and the blood supply may be exposed to emerging infectious agents. In parallel, plasma product quality requirements and drivers are evolving in developed economies as is the awareness of clinicians to newer uses of products such as intravenous immunoglobulins, somewhat deviating from what currently remain the basic needs of developing countries in terms of affordable safe plasma products. Global market trends for plasma-derived products, through plasma fractionation, are still increasing, despite increasing use of recombinant products, and attention is being focused on the five Ws of the fractionation field: which products; where; when; what and how much; and who will be the main suppliers?

Cost-minimization analysis comparing intravenous immunoglobulin with plasma exchange in the management of patients with myasthenia gravis

“…Fifth, the assumption of this study is that PLEX and IVIg are equally available, but the accessibility of resources is actually variable across the world. Although plasma fractionation is largely available among developed countries, local plasma fractionation in developing economies is still challenging in many countries . Therefore, the decision for either therapy must be tailored to the patient's condition and local resources.…”

Creation of Technology of Obtaining of Blood Coagulation Factor Viii With the Use of Macroporous Silica Sorbents With Immobilized Active Dyes

“…Застосування нових терапевтичних плазмових та рекомбінантних препаратів FVIII робить можливим лікування пацієнтів очищеними, стандартизованими, біологічно активними, вірус-безпечними продуктами на противагу використання свіжозамороженої плазми та кріопреципітату [4].…”

“…Ці білки заважають виділенню інших, що є в значно нижчих концентраціях. Тому процес отримання факторів зсідання крові, зокрема FVIII, вимагає попередніх етапів концентрування цих білків: кріопреципітації, переосадженння неорганічними солями та розчинниками, різні види хроматографічних процесів, тощо [4,6].…”

“…Сучасні підходи потребують стандартизації хроматографічного процесу з точки зору селективності, специфічності, багатократного застосування, зменшення собівартості, простоти регенерації сорбенту. Це досягається шляхом створення нових підходів у виборі лігандів та матриць [4,7].…”

Uses of Intravenous Immunoglobulin: A 13-Year Evaluation of Guillain–Barré Syndrome in Fez, Morocco

“…Medical evidence shows that IVIG is benefi cial for treating many off-label indications, which, according to past estimates, represent 50 percent to 80 percent of total IVG use. Export of IVIG was also another factor contributing to the shortage of IVIG [3]. Morocco has depended heavily on importation of plasma derived medicines.…”