TY - JOUR
T1 - Nanomedicine Manufacturing Systems: Scale-Up Fragility, Reproducibility, and Quality Translation
AU - Bruno Martins
AU - Lucas Pereira
AU - Renata Azevedo
AU - Pedro Costa
JF - EAMD 3
Y1 - 0
VL - 0
IS - 0
SP - 172
N2 - Nanomedicines promise therapeutic advantages that are difficult to achieve with conventional dosage forms, including improved targeting, altered pharmacokinetics, protected delivery of fragile payloads, and platform adaptability across drug classes. Yet these benefits depend on manufacturing systems that can repeatedly generate nanoscale products within narrow physicochemical and biological performance windows. The central difficulty is that small changes in process conditions can produce disproportionate changes in particle size, morphology, surface properties, encapsulation efficiency, release behaviour, and biological interaction. Despite decades of academic activity, the translation of nanomedicine from laboratory prototypes to routine clinical and industrial products remains limited. Many formulations are optimised in small batches under conditions that are poorly suited to pilot or commercial production. As a result, promising nanocarriers may fail not because their therapeutic concept is weak, but because their quality attributes cannot be reproduced reliably at scale. The analysis identifies a systemic mismatch between laboratory-optimised formulation methods and industrial requirements for control, documentation, comparability, continuous monitoring, and GMP-ready reproducibility. Four tables synthesise manufacturing platforms, scale-up fragility points, reproducibility challenges, and regulatory or industrial barriers. Together, these syntheses support a translational quality framework centred on process understanding, platform logic, critical quality attributes, and regulatory co-evolution. The review concludes that nanomedicine translation cannot rely on linear scale-up assumptions. Robust translation requires a shift toward platform-based manufacturing, quality-by-design development, integrated process analytical technology, orthogonal characterisation, predictive scale-down models, and shared regulatory learning. Nanomedicines will become clinically credible only when therapeutic innovation is matched by reproducible, affordable, and auditable manufacturing systems.
UR - https://pubsys.eshragh.co/a764521438
ER -