Inter-center comparison of good manufacturing practices-compliant stromal vascular fraction and proposal for release acceptance criteria: a review of 364 productions

Abstract Background Even though the manufacturing processes of stromal vascular fraction for clinical use are performed in compliance with good practices applying to advanced therapy medicinal products, specifications related quality remain poorly defined. We analyzed batches from two independent practices-compliant facilities, Swiss Stem Cell Foundation (SSCF) and Marseille University Hospitals (AP-HM), goal defining appropriate harmonized release acceptance criteria. Methods This retrospective analysis reviewed biological characteristics 364 clinical-grade fraction. Collected data included cell viability, recovery yield, subset distribution fraction, microbiological quality. Results Stromal SSCF cohort demonstrated a higher viability (89.33% ± 4.30%) yield (2.54 × 10 5 1.22 viable nucleated cells (VNCs) per mL adipose tissue) than AP-HM (84.20% 5.96% 2.25 1.11 VNCs mL). were significantly less contaminated (95.71% sterile versus 74.15% batches). The was different (higher proportion endothelial lower leukocytes pericytes cohort). Conclusions Both centers agreed that batch should exert equal or superior 80%, minimum 1.50 tissue, adipose-derived at least 20%, under 50%. In addition, multiparameter gating strategy is proposed.