AI-Driven Innovations for Quality Control and Standardization: Future Strategies in Adipose-Derived Stem Cell Manufacturing

TL;DR

This paper explores how AI can improve the manufacturing of adipose-derived stem cells by enhancing quality control, standardization, and data-driven decision-making.

Contribution

The paper introduces AI-driven strategies for overcoming challenges in ADSC manufacturing, including computer vision and multi-omics integration.

Findings

AI methods like computer vision and label-free imaging can monitor ADSC morphology and proliferation effectively.

Multi-omics combined with ML can predict potency and identify therapeutic biomarkers in ADSCs.

AI offers solutions for standardization and scalability in ADSC manufacturing under GMP conditions.

Abstract

Artificial intelligence (AI), including machine learning (ML) and deep learning (DL), is increasingly transforming the study, manufacturing, and clinical translation of adipose-derived stem/stromal cells (ADSCs). ADSC-based therapies face persistent challenges related to donor variability, heterogeneous cell populations, limited standardization of culture protocols, and the need for robust quality control (QC) and potency assessment under Good Manufacturing Practice (GMP) conditions. This review discusses how AI-driven approaches can support the ADSC pipeline from donor and tissue pre-screening, through isolation and expansion, to differentiation and batch release decisions. We highlight major methodological advances in computer vision and label-free imaging for monitoring morphology, confluency, proliferation, senescence, and contamination, as well as AI-assisted optimization strategies for culture parameters and differentiation protocols. In addition, we examine the growing role of multi-omics integration (transcriptomics, proteomics, metabolomics, and secretomics) combined with ML to predict functional potency, stratify donors, and identify biomarkers associated with therapeutic efficacy. Finally, we address current limitations, including data scarcity, inter-laboratory variability, model interpretability, and regulatory requirements, and outline future perspectives such as closed-loop bioprocess control, foundation models, and federated learning frameworks. Overall, AI offers a powerful toolkit to improve the reproducibility, safety, and scalability of ADSC manufacturing and to accelerate the development of standardized, data-driven regenerative medicine products.

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