Challenges posed by the scale-up of nanomedicines.

The recent cutting-edge developments in nanomedicines have brought numerous advances in the diagnosis and therapy of highly challenging diseases [1]. Nanomedicines, which are medical applications of nanotechnology, are mainly nanoparticle-based drug products. Several comprehensive definitions are now available for nanoparticles in nanomedicine. For pharmaceutical purposes, nanoparticles are colloidal particles that range in size from 10 to 1000 nm (1 μm), they consist of macromolecular materials in which the active principle (drug and/or diagnostic material) is dissolved, entrapped, encapsulated and/or to which the active principle is adsorbed or attached [2,3]. The various types of nanomedicines made are, for example, polymeric nanoparticles, solid lipid nanoparticles, liposomes, dendrimers, polymeric micelles and carbon nanotubes [2]. The US FDA-approved nanomedicine products, such as Doxil (Janssen Products, LP, PA, USA) and Abraxane (Celgene Corporation, NJ, USA), are typical examples of the outcome of aggressive research on nanomedicines, and available in the market for the treatment of ovarian cancer and metastatic breast cancer, respectively [4]. However, nanomedicines still impose many challenges to researchers to obtain the maximum benefits for patients during diagnosis and therapy [5]. The launch of new nanomedicine products on the market is preceded by different developmental stages. A forthcoming major challenge among the developmental stages of nano medicine is industrial scale-up (large scale industrial production). It is well known that nano medicine preparations in the laboratory scale are achievable and well documented by