Review and assessment of the donor safety among plasma donors

Abstract

Human plasma-derived medicinal products (PDMPs) are unique biological therapies derived from human plasma that are used to treat patients with rare, often genetic and chronic, conditions with a high disease burden, as well as acute indications.Despite decades of effective therapeutic use in the United States (US) and Europe and demonstrable clinical and societal value, these treatments still face numerous challenges pertaining to the plasma supply relative to growing demand, the donation landscape, regulatory and reimbursement frameworks, and treatment paradigms.1 As new indications arise and more patients are diagnosed with diseases requiring PDMP treatment, there is a growing clinical need for PDMPs, and considerably more plasma must be collected.Manufacturing from plasma collection to finished product generally takes 7 to 12 months.Plasma used for manufacturing PDMPs may be derived from whole blood donations (recovered plasma) or may be collected by apheresis for the sole purpose of fractionation (source plasma).Source plasma comprises more than 80% of the plasma fractionated in the US, totaling more than 53 million donations in 2019, with recovered plasma representing only 20%.The US

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