Human plasma-derived medicinal products and snake antivenom immunoglobulins are unique and complex therapeutic protein products. Human plasma products are obtained by fractionating large pools of plasma collected from blood plasma donors. They comprise a wide range of protein products, including polyvalent and hyperimmune immunoglobulins, coagulation factors, albumin, and various protease inhibitors that are transfused to patients affected by congenital or acquired protein deficiencies, immunological disorders, or metabolic diseases. Snake antivenoms are manufactured from pools of plasma collected from animals, typically horses, which have been immunized against snake venoms. Transfusing antivenoms is the cornerstone therapy to treat patients affected by snakebite envenoming. Over the last thirty years, much technical and regulatory evolution has been implemented to ensure that this class of biologicals meets modern quality requirements. The purpose of this review is to compare the main developments that took place in plasma production, protein fractionation, pathogen safety, quality control, preclinical and clinical studies, and regulations of these products. We also analyze whether both fields have been influencing and cross-fertilizing each other technically and in regulatory aspects to reach modern safety and efficacy standards at global levels, and how experience in the human plasma fractionation industry can further impact the manufacture of snake antivenom and that of other animal-derived antisera.
- Virus safety
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