Regulatory and Commercialization Challenges with Stimuli-responsive Nanomedicines

Abstract

Nanotechnology aids in the development of smart materials that are capable of overcoming biological barriers and deliver drugs and biologics to the desired site of action with precision. Design and development of such smart materials relies heavily on our improved understanding of the biological barriers, material–biology interaction and our ability to tailor the property of materials to perform a specific function based on the microenvironment of the target tissue and cell. Recent years have seen an increase in efforts to develop such smart materials, but their advancement into clinics and subsequently to the marketplace has been challenging and slow. Being an emerging technology, the challenges in part lie in the three-dimensional (3D) complexity of the nanomaterial constructs, the properties of which can be dramatically different from their individual components and thus the lack of an appropriate yardstick to ensure product quality impedes the development process. Prior experience suggests that a subtle change in the product profile can drastically influence its biological and pharmaceutical performance. This chapter will highlight some key developmental, manufacturing, and regulatory considerations in nanotechnology-based medicines.