Translating Polymeric Drug Delivery Systems from Design to Clinical Readiness

Drug delivery has rapidly evolved from conventional formulations to advanced platforms capable of improving therapeutic efficacy, minimizing systemic toxicity, and enabling precision medicine. Among the available biomaterials, polymers have emerged as highly versatile candidates owing to their tunable physicochemical properties, biocompatibility, biodegradability, and ease of functionalization. Polymeric nanoparticles, micelles, hydrogels, nanogels, dendrimers, and polymer-drug conjugates have demonstrated remarkable potential for the controlled delivery of small molecules, proteins, peptides, nucleic acids, and other active principles. In particular, stimuli-responsive and ligand-functionalized polymeric systems that respond to endogenous or external triggers offer opportunities for site-specific and on-demand drug release.Despite significant progress, the translation of polymeric drug delivery systems from laboratory research to clinical practice remains limited. Many promising platforms demonstrate excellent performance in vitro and in preclinical models but fail to meet requirements for scalable manufacturing, reproducibility, biological performance, safety, regulatory approval, and clinical efficacy. A deeper understanding of the interactions between polymeric carriers and biological systems, including through animal-free model systems such as organ-on-chip and organoid platforms, is also essential to optimize therapeutic outcomes and minimize adverse effects.This Research Topic aims to showcase recent advances in polymeric drug delivery platforms, with a particular focus on the factors that support their translational readiness. It will bring together interdisciplinary contributions that advance the design, characterization, manufacturing, and preclinical evaluation of polymeric drug delivery systems. The collection will highlight strategies for engineering smart and multifunctional materials, improving targeted and stimuli-responsive delivery, integrating computational and artificial intelligence approaches into formulation design, developing new approach methodologies and animal-free model systems for preclinical evaluation, and establishing standardized methods for evaluating quality, safety, efficacy, and reproducibility. By fostering collaboration across materials science, pharmaceutical technology, biology, and clinical research, this collection aims to accelerate the development of robust, scalable, and clinically relevant drug delivery systems.This Research Topic aims to provide a multidisciplinary forum for the latest advances in polymer-based drug delivery systems, spanning fundamental materials design to preclinical and translational applications. Studies focused solely on material synthesis, basic characterization, or in vitro release without a clear translational rationale are outside the scope of this collection.Specific themes include, but are not limited to:- Design, synthesis, and characterization of functional and biodegradable polymers for drug delivery.- Polymeric nanoparticles, micelles, nanogels, hydrogels, dendrimers, vesicles, and polymer–drug conjugates.- Polymer-lipid hybrid nanocarrier systems or Polymer-Lipid Nanoparticles (PLNPs) for targeted, stimuli-responsive, or controlled (long-acting) drug delivery. - Stimuli-responsive and smart delivery systems triggered by pH, temperature, enzymes, redox conditions, light, magnetic fields, or ultrasound- Targeted delivery of small molecules, proteins, peptides, nucleic acids, vaccines, gene-editing tools, and biologics.- Biomaterial-cell interactions, biodistribution, pharmacokinetics, immunogenicity, and biosafety.- New approach methodologies and animal-free model systems for evaluating polymeric drug delivery systems.- Scalability, manufacturing, batch-to-batch reproducibility, stability, sterilization, and critical quality attributes.- Clinically relevant models, translational validation, and regulatory considerations for polymeric delivery systems.- Artificial intelligence, machine learning, and computational approaches for the design and optimization of drug delivery systems.We encourage the submission of Original Research, Review, Systematic Review, and Mini Review articles that provide innovative insights, critical analyses, and emerging concepts in advanced polymeric drug delivery and translational readiness.Dr. Shehaab Savliwala is employed at Singota Solutions, a privately-owned pharmaceutical contract manufacturing and development organization. Topic editors: Leonard Atanase, Shehaab Savliwala, Christopher Synatschke Source: https://www.frontiersin.org/research-topics/84159/translating-polymeric-drug-delivery-systems-from-design-to-clinical-readiness