Clinical feasibility and cost efficiency of perinatal mesenchymal stem cell production under GMP conditions

Perinatal tissues such as umbilical cord, amniotic fluid, amniotic membrane, and placenta contain mesenchymal stem cells (MSCs) with clinical potential; however, a direct comparison of these sources under Good Manufacturing Practice (GMP) conditions remains limited. To evaluate and compare perinatal tissue types in terms of viable MSC yield, sterility, and GMP-adjusted processing cost in order to identify practically applicable sources for clinical-grade biobanking. A total of 160 perinatal tissue samples were collected from 32 term pregnancies during elective cesarean delivery. Standardized GMP protocols were applied for MSC isolation, sterility screening using automated BACTEC™ culture systems, and immunophenotypic characterization in accordance with ISCT criteria. Multivariate linear regression was used to identify independent predictors of MSC yield. Cost modeling included reagents, labor, and cryostorage within a laboratory-scale GMP setting. Umbilical cord tissue yielded the highest number of viable MSCs (6.5 × 10⁶ ± 0.8 cells/sample), followed by amniotic fluid (5.8 × 10⁶ ± 0.6). Amniotic fluid exhibited the lowest contamination rate (3%), whereas placental tissues demonstrated higher microbial burden (18-21%). Tissue type was the strongest predictor of MSC yield (β = 0.61, p < 0.001). Normalized cost analyses indicated that umbilical cord and amniotic fluid offered the most favorable yield-to-cost profiles. Under current GMP conditions, umbilical cord and amniotic fluid appear to provide the most balanced combination of MSC yield, sterility, and processing cost. These findings support a practical framework for tissue selection and workflow optimization in perinatal MSC biobanking and translational regenerative applications.