Proceedings of the Food and Drug Administration public workshop on pathogen reduction technologies for blood safety 2018 (Commentary, p. 3026)

Atreya, Chintamani; Glynn, Simone; Busch, Michael; Kleinman, Steve; Snyder, Edward; Rutter, Sara; AuBuchon, James; Flegel, Willy; Reeve, David; Devine, Dana; Cohn, Claudia; Custer, Brian; Goodrich, Raymond; Benjamin, Richard J.; Razatos, Anna; Cancelas, Jose; Wagner, Stephen; Maclean, Michelle; Gelderman, Monique; Cap, Andrew; Ness, Paul

Using solvent/detergent-treated pooled plasma (Octaplas): implementation at University of Minnesota-Claudia Cohn, MD, PhD Speaker's summary: Octaplas, an FDA-approved blood component, is S/D-treated plasma that is manufactured by combining multiple ABO-matched plasma units from healthy US donors. The plasma units, which are frozen within 8 hours of collection, are pooled (approx. 380 L from 630 to 1520 donors in the United States) and then filtered to remove residual cells and treated with a combination of 1% tri(nbutyl)-phosphate and 1% octoxynol to inactivate enveloped viruses. The residual S/D is removed by oil extraction and chromatography. The final product is sterile-filtered, aliquoted into 200-mL bags, and stored frozen. 94 Octaplas is indicated for replacement of coagulation factors in patients with acquired deficiencies due to liver disease or undergoing cardiac surgery or liver transplant and for plasma exchange in patients with thrombotic thrombocytopenic purpura. Octaplas is contraindicated in patients with immunoglobulin A deficiency and severe deficiency of protein S. All other contraindications, including a history of hypersensitivity to fresh-frozen plasma and/or plasma-derived products, are common to conventional plasma components. Octaplas may be stored for up to three years at not more than − 18 C. After thawing, Octaplas may be stored for 24 hours at +1 to 6 C or for 8 hours at room temperature.