Challenges associated and approaches for successful translation of nanomedicines into commercial products.

Nanomedicines are complex engineered nanoscale structures and are widely used in the treatment and targeting of diseases because of their numerous therapeutic benefits. These benefits are: protection of biomolecules from degradation, enhanced solubility and bioavailability, improved pharmacokinetics, reduced toxicity, enhanced therapeutic efficacy, decreased drug’s immunogenicity, delivery at the target site and diagnostics/ treatment options in one system [1–4]. Several nanomedicine products have been approved by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for various therapeutic indications [2,5–6]. High therapeutic efficacy and safety are the two primary qualifications for a product to become commercially successful. But, most of the nanomedicine products fail to accomplish these requirements and thus their successful commercialization [7]. Limited clinical success of nanomedicines is mainly due to challenges in formulation optimization, batch-to-batch consistency, robust and reproducible manufacturing and scale-up, characterization and screening methods, regulatory barriers and instability under biological environments [2,7–8]. Specific properties of nanomedicines those are responsible for their numerous benefits also generate safety and translational challenges. Thus, understanding the fundamental, clinical and regulatory aspects of nanomedicine is of paramount significance. In this editorial, challenges associated with the successful translation of nanomedicines from preclinical to commercial stage and suggested approaches to achieve this translation are discussed. Nanopharmaceutical drug delivery and therapeutic systems are collectively referred as nanomedicines in this article.