(P-BC-59) In Vivo 24-Hour Recovery and in Vitro Quality Assessment of Apheresis Leukoreduced Red Blood Cells Collected and Stored for 42 Days in Non-DEHP Disposable Sets

Background/Case Studies: The use of di(2-ethylhexyl) phthalate (DEHP) plasticized materials in blood bags will be restricted in the European Union on 01 July 2030, prompting the need for alternative materials. In vitro and in vivo quality evaluation is essential to ensure transfusable red blood cell (RBC) products continue to meet regulatory standards during non-DEHP transition.

Study

Design/Methods: These prospective, open-label studies enrolled healthy adults who consented to undergo an apheresis RBC collection with automatic device leukoreduction (LR) using The Trima Accel™ Automated Blood Collection System (Terumo BCT, Lakewood, CO) and non-DEHP disposables plus Additive Solution Formula 3. Adverse events were monitored to assess participant safety. Phase 1: In vitro quality parameters were evaluated on Days 0, 35, and 42 against United States Food and Drug Administration (FDA) and European Directorate for the Quality of Medicines & HealthCare (EDQM) standards. Phase 2: Participants received a radiolabeled autologous infusion on Day 42 to determine 24-hour RBC recovery using both single- (chromium-51) and dual-label (chromium-51/technetium-99m) methods evaluated against FDA’s 3-part criteria.

Results/Findings: Phase 1: 72 participants were enrolled with 61 evaluable LR-RBC products obtained for in vitro assessment. Results are shown in Table 1. All FDA criteria were met except for Day 0 RBC Filtration Recovery (acceptable threshold ≥85%), with one unit failing and the one-sided 95% confidence interval (CI) lower bound at 92.5% (FDA threshold ≥95%). All EDQM criteria were met except for Day 0 Hematocrit (acceptable range: 50–70%), with 8 units outside range and the CI lower bound at 77.6% (EDQM threshold ≥90%). Failure analyses suggested overestimated hematocrit values entered into the apheresis device during donor qualification resulting in lower unit hematocrit values.

Phase 2: 37 participants were enrolled with 25 evaluable data points obtained for 24-hour RBC recovery. For the single- (n=25) and dual-label (n=24) methods, respectively, the one-sided lower CIs for the proportion of RBC components with percent recoveries >75% was 82.4% and 76.0% (≥70%), the sample means were 84.6% and 83.8% (≥75%), and the sample standard deviations were 6.40% and 6.01% (≤9%).

No serious adverse events or unanticipated adverse device effects were reported in either phase.

Conclusions: Apheresis LR-RBC products collected using non-DEHP disposables and stored for 42 days met in vitro FDA and EDQM criteria, with any parameter failures considered artifactual. Products met FDA's 3-part in vivo 24-hour RBC recovery criteria, supporting their use as acceptable transfusable blood products.