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Copyright: ©Author(s) 2026.
World J Stem Cells. Jul 26, 2026; 18(7): 120363
Published online Jul 26, 2026. doi: 10.4252/wjsc.120363
Table 4 Translational bottlenecks and mitigation approaches
Translational challenge
Impact on clinical translation
Proposed mitigation strategy
Ref.
Batch heterogeneityVariable efficacyStandardized MSC banking[180]
Donor variabilityProduct heterogeneityDefined donor selection criteria[21]
Low scalabilityLimited clinical productionBioreactor + TFF systems-based manufacture[181]
Stability issuesCold-chain dependenceLyophilization with trehalose[182]
Regulatory ambiguityDelayed approvalEarly regulator[183]
Potency assay standardizationDifficulty assessing therapeutic activitiesFunctional bioassay validation[180]
Comparability after process changeRegulatory approval riskAnalytical comparability testing[177]
Storage stability limitationsReduced shelf-lifeCryopreservation optimization[182]
Cost effectivenessManufacturing feasibility concernsProcess automation[181]


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