(P-BT-27) Survey Comparison: Variability in Allogeneic Hematopoietic Progenitor Cell Product Counts between US and non-US Collection Centers.

AABB Cell Therapy Standard 5.28 for incoming cell therapy products requires verification of labeling, traceability, donor eligibility, & “product attributes.” CT Standard 5.10 has additional requirements including product testing & review/retention of collection center (CC)/manufacturers Certificate of Analysis (CoA) or equivalent. Although it is standard for CC to provide the volume & total CD34 yield for peripheral blood hematopoietic progenitor cell products (HPC-A), information for other product attributes is neither defined nor required.

Study

Design/Methods:

Batch records of all allogeneic, non-cryopreserved, HPC-A products received from external CC between 1/1/2023 & 4/30/2024 were reviewed: Marrow & HPC-A with missing CC product counts were excluded. External CC product information was examined for document type (electronic, CC-specific CoA) & product information (volume, total cell yield [total nucleated cells (TNC) or WBC; TNC/kg], cell concentration [WBC/vol], WBC differential [% MNC], platelet (PLT; per volume, total), RBC contamination [% Hct, total mL], CD34 [total CD34, CD34/kg], % viability, lymphocyte content [CD3, CD4, CD8, CD19, CD56]. Product information was compared by document type & CC (US vs international [internl]). Statistics were performed with commercial software.

Results/Findings:

External product CC count data was available for 89/103 allogeneic HPC-A products (86%) from 10 countries & 27 CC (Table 1). Most US-CCs (34/36, 94%) uploaded product information electronically including the WBC/uL (32/34, 94%), %MNC (85%), PLT/uL (88%), %HCT (88%), total CD34 yield (97%), % viability & method (76%; 7-ADD). Two US-CC provided CC-specific CoA with product volume (2/2), TNC/kg (1), %CD34 (1), total CD34 (1), & viability (2).  In contrast, CC-specific CoA were provided for all 53 products from internl-CC (P< 0.001). Most internl-CC (92%) provided cell counts as total cell count (89%), cell concentration (3.8%) or both (11%) & reported as TNC (64%), CD45+ (26%) or WBC (7.5%). CD34 yields were reported as either total CD34 (45/53, 85%), CD34/kg (81%), or %CD34 (23%) with %viability reported in only 53% products. One internl-CC provided CD34 collection efficiency. Lymphocyte content was reported as %MNC (17%), MNC/kg (2%), total CD3+ (38%), CD3/kg (34%), CD19/kg (6%), CD56/kg (4%). RBC contamination was reported in 72% as %Hct (60%) & total mL (25%). PLT content was reported in 28% as total per product (21%) or PLT/vol (7.5%).

Conclusions:

HPC-A product content provided by external CC varies significantly, particularly between internl-CC. CC-specific CoA often provided more detailed product quality data than the electronic product data preferred by US-CC.