This review highlights the biological characteristics, biogenesis, sources, isolation, purification, and characterization techniques of exosomes, and summarizes the applications of exosome-based drug delivery in cancer, neurological disorders, cardiovascular diseases,inflammatory conditions, infectious diseases, regenerative medicine, and gene therapy.
Abstract
Exosome-based drug delivery systems have emerged as a promising platform for targeted therapeuticsand precision medicine because of their excellent biocompatibility, low immunogenicity, and intrinsicability to transport diverse therapeutic molecules. Unlike conventional nanocarriers, exosomesefficiently deliver proteins, nucleic acids, and small-molecule drugs while overcoming biologicalbarriers, including the blood–brain barrier. This review highlights the biological characteristics,biogenesis, sources, isolation, purification, and characterization techniques of exosomes. It alsodiscusses recent advances in drug-loading strategies, surface engineering, and exosome modification toimprove targeting efficiency and therapeutic performance. Furthermore, the review summarizes theapplications of exosome-based drug delivery in cancer, neurological disorders, cardiovascular diseases,inflammatory conditions, infectious diseases, regenerative medicine, and gene therapy. Despite theirremarkable therapeutic potential, challenges related to large-scale production, standardization, storagestability, and regulatory approval remain significant barriers to clinical translation. Continued researchand technological advancements are expected to facilitate the successful integration of exosome-basedtherapeutics into personalized healthcare.
Exosomes are small extracellular vesicles (30–150 nm) secreted by most cell types, carrying proteins, lipids, and nucleic acids that mediate intercellular communication. Their natural biocompatibility, low immunogenicity, ability to cross biological barriers, and intrinsic targeting properties have attracted intense interest for therapeutic and drug delivery applications. Exosomes can be loaded with small molecules, proteins, or nucleic acids and engineered to display targeting ligands, enabling precise delivery to specific tissues or cells. This review critically examines the current state of exosome-based therapeutics, focusing on isolation methods, engineering strategies, and clinical translation through early 2024. Isolation techniques include ultracentrifugation, size-exclusion chromatography, and microfluidic approaches, each with trade-offs in purity, yield, and scalability. Engineering strategies encompass cargo loading via electroporation, sonication, or co-incubation, and surface modification using chemical conjugation or genetic fusion. Preclinical studies have demonstrated therapeutic potential in oncology, cardiovascular disease, neurological disorders, and regenerative medicine. Several clinical trials are evaluating exosomes, including mesenchymal stem cell-derived exosomes for COVID-19 and graft-versus-host disease, and plant-derived exosomes for drug delivery. Challenges include heterogeneity, scalable manufacturing, batch-to-batch reproducibility, regulatory classification, and biodistribution. Future directions include standardized isolation and characterization, improved cargo loading efficiency, and development of allogeneic off-the-shelf products. Exosome-based therapeutics hold promise, but rigorous quality control and clinical evidence are required.
Unknown authors· Global Journal of Research i...· 0 citations
A structured translational roadmap is proposed that prioritizes biologically predictive design, fit-for-purpose safety assessment, scalable good manufacturing practice production, early regulatory alignment, and clinically meaningful benefit over unnecessary structural complexity.
Yi Li, Rui Luo, Yuxuan Li et al.· Biomedicine & pharmacotherap...· 0 citations
Exosome mimetic nanocarriers have risen as a progressive biomimetic approach for intracellular drug delivery, exploiting the unique properties of natural exosomes to enhance therapeutic precision and efficacy. These synthetic vesicles imitate the structural, biochemical, and functional characteristics of natural exosomes, including lipid bilayer composition, surface proteins, and molecular cargo, offering superior biocompatibility, immune evasion, and targeted delivery capabilities. Unlike traditional nanocarriers, exosome mimetics exploit receptor-mediated endocytosis and natural cellular communication pathways to facilitate efficient intracellular transport and controlled release of therapeutic payloads such as chemotherapeutic agents, nucleic acids(siRNA, miRNA, mRNA) and proteins. Engineering strategies combine advanced liposome technologies with exosomal components to overcome challenges of yield, scalability, and immunogenicity, enabling customizable and reproducible drug carriers. This chapter comprehensively reviews the design principles, fabrication methods, and functionalization techniques of exosome-mimetic nanocarriers, emphasizing their advantages in precision oncology. Mechanistic insights into cellular uptake, endosomal escape, and tumor targeting are comprehensive alongside preclinical studies demonstrating enhanced antitumor efficacy and safety profiles. Furthermore, the chapter discusses translational hurdles, including standardization, large-scale production, and regulatory considerations. Integration with emerging artificial intelligence tools and multiomics theranostics presents future opportunities for optimizing nanocarrier design, patient stratification, and treatment monitoring. Overall, exosome-mimetic nanocarriers represent a transformative strategy in nanomedicine, poised to revolutionize intracellular drug delivery and enable precision personalized therapy in breast cancer and beyond.
Keywords: Exosome, breast cancer, exosome-biomimetic nanocarriers, intracellular drug delivery, cargo loading, targeted therapy.
T. Shah· Journal of Drug Delivery and...· 0 citations
This review critically examines exosome sources, isolation and characterization methodologies, cargo-loading strategies, biodistribution, pharmacokinetics, and engineering approaches together with their applications in delivering small-molecule drugs and nucleic acid-based therapeutics to overcome multidrug resistance in cancer.
Yaseera Arif, D. N. Moholkar, Raghuram Kandimalla et al.· Journal of Controlled Releas...· 0 citations
Despite their promise, significant challenges remain, including low cargo-loading efficiency, batch heterogeneity, limited scalability and the absence of standardized manufacturing and regulatory frameworks, future research must address these barriers to accelerate the clinical translation of exosome-based therapeutics.
Elza Karabagh, Babek Alibayov, Adil Allahverdiyev· Expert Reviews in Molecular...· 0 citations
Extracellular vesicles (EVs) are naturally occurring nanoscale carriers that have gained attention as next-generation platforms for diagnostics, site-specific drug delivery, and tissue engineering owing to their high biocompatibility, minimal immunogenicity, and capacity to transport diverse bioactive cargo across biological barriers. This review discusses the classification, biogenesis, molecular constituents, and therapeutic properties of the major EV subtypes such as exosomes, microvesicles, and apoptotic bodies. It also highlights recent advances in EV engineering for cancer treatment, emphasizing immune modulation and targeted therapeutic delivery. Particular attention is given to plant-derived EVs, which have shown promise as scalable, low-toxicity nanotherapeutics with inherent bioactivity and effective drug delivery potential. Selected preclinical studies, recent patents, and ongoing clinical trials are also summarized, providing an up-to-date perspective on the clinical translation of EV-based technologies. Current challenges in EV isolation, characterization, scalable manufacturing, cargo loading, standardization, and regulatory approval, along with future directions for clinical translation, are summarized. Collectively, this review summarizes the growing applicability of EVs as next-generation platforms for precision medicine, targeted drug delivery, and regenerative therapies while identifying the major obstacles that must be addressed to facilitate their successful clinical translation.
Shery Jacob, Namitha Raichel Varkey, S. Boddu et al.· Pharmaceutics· 0 citations
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