Abstract

This conceptual analysis discloses, as defensive prior art (CC BY 4.0), an efficacy-cost decision framework for ensuring pathogen safety of ambient-temperature dried red blood cells (RBCs) produced where laboratory donor screening is incomplete and transfusion-transmitted-infection burden is high. No experimental potency, recovery, or inactivation data are generated; every value is a cited literature anchor or labelled estimate. An earlier version over-stated riboflavin-UV efficacy by quoting plasma/platelet log-reductions for red cells; this is corrected, as haemoglobin attenuates UV and lowers whole-blood efficacy (SARS-CoV-2 about 3.3 log in whole blood vs about 4.8 in plasma; Ragan et al. 2020). The problem is reframed as a choice among three pathogen-reduction strategies applied before drying: (A) riboflavin + UV (Mirasol, whole-blood format), a non-toxic, residue-free option with a randomised malaria-reduction benefit (Allain et al. 2016) and demonstrated downstream red-cell quality (Dimberg et al. 2019); (B) amustaline (S-303) + glutathione (INTERCEPT), the broadest-spectrum (>=4 log) and most clinically advanced red-cell system (Phase 3 ReCePI; Cancelas et al. 2017), at higher cost; and (C) a screening-led approach, lowest-cost but below a standalone safety threshold and suitable only as an adjunct. scCO2 is used solely for drying, never claimed as inactivation, and pathogen reduction is positioned as an adjunct to, not a replacement for, donor screening. Validation against the dried product is required before any use. This disclosure keeps accessible pathogen-safety strategies in the public domain. This is a prior-art disclosure, not deployment, regulatory, or clinical guidance.

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Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 License.

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