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

Current status of pathogen-reduced platelets in the United States-Edward Snyder, MD, FACP, and Sara Rutter, MD Speaker's summary: Pathogen-reduced PLTs manufactured using a synthetic psoralen compound (amotosalen) are approved by the FDA for use by all patient demographics. [21] [22] [23] [24] Currently this is the only PLT PR manufacturing system approved by the FDA in the United States. It requires ultraviolet (UV)-A light activation of the psoralen photochemical to enable it to function as the inactivation agent. [21] [22] [23] [24] [25] Approval is limited to single-donor PLTs collected using either of two apheresis devices and stored in a PLT additive solution, PAS-C, or in autologous donor plasma, depending on the apheresis device used for manufacture. Both PR products have a 5-day shelf life at 20 to 24 C. 23 The psoralen product currently is being evaluated in PIPER, a Phase IV postmarketing study. Other manufacturing systems are under varying degrees of development. 26, 27 One of these systems uses a different light-activated photochemical, riboflavin, and is currently being evaluated in the United States in a Phase III randomized clinical trial, MIPLATE. 28 A third PR technology uses a shorter wavelength of UV light (UVC), as the sole mechanism of inactivation. 27, 29, 30 It, too, is being evaluated in CAPTURE, a Phase III clinical trial in Europe.