Journal of Cell Science & Therapy
Open Access

Regulatory and Manufacturing and Functional Challenges of Exosome Integrations

Peng Yan^{* *}Correspondence: Peng Yan, Department of Regenerative Medicine and Biotechnology, School of Medicine, Zhejiang University, Zhejiang, China, Email:

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Description

Extracellular vesicles classified as exosomes usually ranging from 30 to 150 nm in diameter are released by almost all cell types and carry a diverse repertoire of biomolecules, including proteins, lipids, messenger RNAs, microRNAs and DNA fragments. These nanoscale entities are generated within multivesicular bodies and secreted via fusion with the plasma membrane, thereby providing a mechanism for inter- cellular communication beyond classical soluble ligand receptor systems. In biological systems, exosomes take part in physiological processes such as tissue repair, immunomodulation and maintenance of cellular homeostasis. At the same time, their involvement in pathological processes including tumour progression, inflammation and infectious disease has become increasingly evident. These dual roles position exosomes as both biomarkers of disease state and possible therapeutic vehicles.

From a diagnostic standpoint, the presence of exosomes in accessible body fluids (e.g., blood, urine, saliva) makes them attractive as non-invasive indicators of cellular state. Their cargo reflects the status of the donor cell and molecular signatures within these vesicles have been correlated with disease presence and progression. The utility of exosomal biomarkers is constrained by issues such as heterogeneity of vesicle populations, lack of standardised isolation protocols and variance in cargo loading. Technologically, substantial effort has been devoted to isolation, purification and characterisation of exosomes. Ultracentrifugation, size-exclusion chromatography, immunoaffinity capture and microfluidic methods have all been developed or refined. Even so, differing yields, morphological overlap with other extracellular vesicles and lack of universally agreed metrics remain recurring obstacles.

Therapeutic deployment of exosomes draws on their natural delivery capacity. They can transport molecular cargo, including therapeutic nucleic acids or proteins, across biological barriers, with minimal immunogenicity relative to cell-based therapies. Modifying the surface and cargo content of exosomes has drawn substantial interest as a strategy to boost target specificity and enhance therapeutic payload delivery. Yet, translation to clinical use remains hindered by challenges in large- scale production, standardised characterisation, biodistribution control and regulation of off- target effects. Understanding the biological basis of exosome biogenesis, cargo- sorting and recipient-cell uptake remains essential. Variations in donor cell type, physiological state, secretion trigger and cargo composition influence functional outcome, the source of an exosome population matters for application strategy.

Moreover, the kinetics of exosome circulation, clearance, targeting and internalisation influence efficacy for both diagnostic and therapeutic purposes. Purity and reproducibility in isolation are paramount and contaminating proteins, lipoproteins or other vesicle species may confound data or reduce therapeutic safety. Characterisation parameters including size distribution, marker expression, cargo content and functional assays require harmonisation across studies to facilitate meaningful comparison. Regulatory and manufacturing frameworks are needed that address cell-derived vesicles, given their complex nature and potential immunological implications. Exosomes represent a compelling modality but require rigorous scientific and technical foundations. Achieving meaningful diagnostic or therapeutic impact will depend on bridging mechanistic insight with scalable, reproducible production and well-controlled clinical evaluation. The study of exosomes occupies an intersection of cell biology, nanotechnology and translational medicine. Their capacity to transport biologically active cargo, reflect cellular state and traverse biological barriers makes them uniquely suited to serve as biomarkers and delivery vehicles. To realise that potential, consistent methodology, clear definition of vesicle populations, robust functional characterisation and careful patient centred evaluation will be essential. With these in place, exosomes may significantly augment the toolkit of molecular diagnostics and targeted therapeutic delivery.