Translational Nanomedicine: Bridging the Gap Between Smart Delivery Systems and Quality Control

Rehan Mujtaba, Sumaiya Karim, Md Suhaib Ahmed

Vol. 21, Issue 1, Jan-Jun 2026

Abstract:

Despite the fact that research into nanomedicine has made it possible to discover fascinating new avenues for the distribution of medications, there is still a significant distance to go before the limited number of nanomedicine products that have been granted regulatory clearance can compete with the innovative smart delivery systems that have been developed in laboratories. In spite of the dramatic growth in both academic publications and technological skill, the proportion of nanomedicine research that results in therapies that are commercially viable is less than one percent. A number of issues, including those pertaining to regulation, quality control, safety, and the scalability of manufacturing, have contributed to this distinction. In addition, it is the outcome of inconsistent clinical performance, which is particularly troublesome when dealing with biological phenomena such as the Enhanced Permeability and Retention (EPR) effect, which may vary greatly from one instance to the next. There were early successes that demonstrated the viability of the notion, such as lipid nanoparticle platforms and liposomes, but these platforms also demonstrated that there were limitations in terms of repeatability and predictability. Therefore, it is necessary to employ improved formulation procedures in order to overcome biological obstacles. Lipid-based, polymer-based, hybrid/inorganic systems, and carriers originating from biological sources are some of the techniques that fall under this category. In order for these ideas to become a reality, there must be stringent control over key quality attributes (CQAs), a comprehensive characterization of bio-nano interactions, scalable procedures that are in accordance with Good Manufacturing Practice (GMP), and unified regulatory channels. The DELIVER framework provides structured instructions for synchronizing the steps of early-stage design, experimental validation, production preparation, and regulatory strategy. This is done with the intention of reducing the likelihood of translational risk occurring. It is essential to place a high priority on quality-by-design (QBD), immunological risk assessment, standardized analytical methodologies, and early regulatory participation in order to increase clinical success rates. Last but not least, in order to bring nanomedicine products that are safe, effective, and reproducible from the laboratory to the bedside of the patient, it is necessary to bridge the gap between the development of smart nanocarriers and the incorporation of quality control.

DOI: http://doi.org/10.37648/ijrmst.v21i01.002

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