Virus-like particles as a unifying platform bridging prophylaxis, precision medicine, and advanced therapeutic modalities

Abstract Virus-like particles (VLPs) are self-assembling biomimetic nanostructures that mimic viral morphology while lacking infectious genetic material, making them useful platforms for vaccines, immunotherapies, drug and gene delivery, and diagnostic systems. This review summarizes VLP fundamentals, classification, production systems, characterization methods, cargo-loading strategies, and biomedical applications, with emphasis on structure–property relationships and translational constraints. We discuss established prophylactic vaccine precedents and distinguish them from emerging therapeutic, mRNA-delivery, CRISPR/Cas-delivery, imaging, and AI-assisted design applications that remain largely preclinical or early translational. We also examine manufacturing and regulatory challenges, including expression-system trade-offs, scalability, cost, glycosylation, impurity control, potency assays, critical quality attributes, and batch comparability. Particular attention is given to biohybrid and composite design features, including capsid engineering, surface functionalization, lipid or polymer modification, and cargo incorporation. By integrating materials engineering, immunology, biomanufacturing, and regulatory perspectives, this review presents VLPs as adaptable biohybrid nanomaterials whose clinical value depends on reproducible design, validated characterization, scalable production, and evidence-based implementation. Graphical abstract Schematic overview of VLPs as modular biomedical platforms. The graphic summarizes their core properties, structural classes, expression systems, cargo-loading strategies, characterization methods, therapeutic and diagnostic applications, and major translational challenges. VLPs integrate self-assembly, high immunogenicity, surface engineering, and cargo capacity, supporting applications in vaccines, cancer immunotherapy, gene and RNA delivery, imaging, and targeted drug delivery. Key barriers to global translation include manufacturing complexity, batch consistency, glycosylation control, stability, scalability, and regulatory harmonization.