An overview of plasma fractionation

Abstract

The fractionation of human plasma still essentially remains the only biotechnological approach to make several life-saving protein therapeutics required to treat several human diseases. Plasma products include a range of coagulation factors (such as factor VIII, factor IX, the prothrombin complex, Von Willebrand factor, or fibrinogen and several others), polyvalent and hyperimmune (such as anti-RhO, anti-hepatitis B, anti-rabies, or anti-tetanus) immunoglobulins (IgGs), protease inhibitors (such as alpha 1-antitrypsin and C1-inhibitor), anticoagulants (such as antithrombin), and albumin. Considering the therapeutic role played by these products at global level, it is essential that they are extracted from human plasma by applying properly regulated industrial processes capable to ensure optimal quality, safety, and recovery. The current plasma fractionation methods used by the pharmaceutical industry still derive from the cold ethanol precipitation process developed in the 1940’s by Cohn and his collaborators. However, the technology, and the manufacturing practices used, have evolved dramatically in the last few years to provide optimized selective hemotherapy to patients, ensure optimal use of the plasma raw material limited resource, and last, but not least, introduce dedicated treatments to increase the safety margin and avoid virus transmissions. This review analyzes the current status of the plasma fractionation industry and its likely development in the foreseeable future.