Stored red blood cell viability is maintained after treatment with a second‐generation S‐303 pathogen inactivation process

Abstract

RBCs prepared using the S-303 pathogen inactivation process were physiologically and metabolically suitable for transfusion after 35 days of storage, met the FDA guidance criteria for 24-hour recovery, and did not induce antibody formation.

Measurement of Posttransfusion Red Cell Survival With the Biotin Label

“…FDA licensing of RBC storage media requires that mean PTR 24 be ≥ 75% with a standard deviation ≤ 9% and a 95% CI lower limit ≥ 70% after transfusion of labeled autologous RBC [86]. More recently, the FDA is also requiring manufacturers to determine the long-term survival of RBC in vivo [9]. The current methods applied in FDA licensure are 51 Cr radiolabeling for RBC recovery and survival and 99 Tc(m) for blood volume determinations.…”

“…For RBC produced during steady state erythropoiesis that exhibit linear removal for a substantial fraction of their lifespan, the linear portion of the survival curve may be extrapolated to the x-axis to determine the RBC lifespan (“mean potential lifespan”, MPL). Reduced, but still linear, survival may be seen in some types of storage lesions where the overall population of RBC is affected enough to decrease survival [9, 10]. For RBC with nonlinear removal (e.g., RBC in sickle cell disease, other severe hemolytic states, and even in some normal individuals [3]), a half-time for removal (denoted T 50 ) is useful, as reviewed in [1].…”

Measurement of Red Cell Lifespan and Aging

“…RBC survival determinations are rarely performed for clinical purposes, but there are a number of investigational circumstances in which they are useful, including: i) evaluation of RBC storage and pathogen inactivation [33][34][35]; ii) studies of the pathophysiology of sickle cell disease [19][20][21][22]; iii) the importance of RBC lifespan in diabetes as an explanation of mismatches between blood glucose and HbA1c [1]; iv) studies of the optimum RBC transfusion product for premature newborns [17]; v) poorly understood anemias including those associated with chronic inflammation [36] and the elderly; vi) investigations of RBC aging and senescence. Studies of transfusion products require a population-type, ex vivo label.…”

Babesia: An Emerging Infectious Threat in Transfusion Medicine

“…No pathogen reduction technology for RBC units is commercially available at the present time, although there are two major platforms that are poised to change this status. The first is a technology (Cerus Corporation, Concord, California) based on the use of S-303, an intercalator group that inserts into the helical region of the nucleic acid, an effector group that allows covalent modification of nucleic acid, and a central frangible bond that allows degradation of the compound [20]. The second is the Mirasol PRT system (TerumoBCT Biotechnologies, Lakewood, Colorado), which uses a riboflavin additive that is UV light-activated to treat platelets, plasma, and whole blood [21].…”