Nanomedicines: From Bench to Bedside and Beyond

Abstract

Advancing nanomedicines from concept to clinic requires integration of new science with traditional pharmaceutical development. The medical and commercial success of nanomedicines is greatly facilitated when those charged with developing nanomedicines are cognizant of the unique opportunities and technical challenges that these products present. These individuals must also be knowledgeable about the processes of clinical and product development, including regulatory considerations, to maximize the odds for successful product registration. This article outlines these topics with a goal to accelerate the combination of academic innovation with collaborative industrial scientists who understand pharmaceutical development and regulatory approval requirements-only together can they realize the full potential of nanomedicines for patients.

Vascular Drug Delivery Using Carrier Red Blood Cells: Focus on RBC Surface Loading and Pharmacokinetics

“…While this may not be a significant concern for drugs with good bioavailability and/or wide therapeutic indices, this is often a limiting factor in efficacy. Approaches to extend the circulation time and to improve targeted delivery of therapeutics, such as encapsulation in liposomes (hours-days) and conjugation to mAbs (days-weeks), have been applied clinically with some success [108,109]. However, there is no method for improving PK approaches the potential of coupling to RBCs, which circulate with a lifespan of 100-120 days in adult humans ( Figure 3B).…”

Staggered Herringbone Microfluid Device for the Manufacturing of Chitosan/TPP Nanoparticles: Systematic Optimization and Preliminary Biological Evaluation

“…The great potential of polymeric nanoparticles (NPs) in treatment, prevention and diagnosis of diseases is exemplified by several decades of research and an ever-growing number of related publications in this area; nevertheless, few NPs-based formulations have achieved successful clinical translation and even fewer have received marketing approval from health authorities [1][2][3][4]. To overcome the gap and accelerate the translation from bench to bedside, unmet technical issues and concurrent regulatory aspects still need to be faced [5]. From a technical perspective, promising polymeric NPs-based formulations present unique chemistry, manufacturing and control challenges relying essentially to the choice of suitable polymeric material as well as the development of robust and easy-scalable preparative procedure in order to obtain NPs with reproducible morphological and physicochemical attributes (size, polydispersity, composition, charge and shape) greatly affecting NPs in vivo biodistribution [5,6].…”

“…To overcome the gap and accelerate the translation from bench to bedside, unmet technical issues and concurrent regulatory aspects still need to be faced [5]. From a technical perspective, promising polymeric NPs-based formulations present unique chemistry, manufacturing and control challenges relying essentially to the choice of suitable polymeric material as well as the development of robust and easy-scalable preparative procedure in order to obtain NPs with reproducible morphological and physicochemical attributes (size, polydispersity, composition, charge and shape) greatly affecting NPs in vivo biodistribution [5,6].…”

Nanoparticle–allergen complexes for allergen immunotherapy

“…Moreover, the suitability of current toxicological methods to facilitate satisfactory and exhaustive risk assessment remains under discussion. 23,24 Nonetheless, a number of medicinal products containing NPs in the form of liposomes, polymer protein conjugates, polymeric substances or suspensions, and nanocrystals have already been granted Marketing Authorizations within the European Community and/or at the world level under the existing regulatory framework. 18,23 Several nanodrugs are undergoing basic research and preclinical and clinical development, the entire process of which can take up to 20 years.…”