ABSTRACT
This chapter focuses on the biologics, biotechnology products, nanomedicines, nanodrug products, and nanomaterials that are used for medicinal purposes in humans. Advances in immune aspects of biologics and nanodrugs have created tremendous opportunity to accelerate the discovery and development of these novel therapeutic agents to treat devastating human diseases. Nanodrugs may have unique properties that can be beneficial for various clinical applications but there is no specific size range or dimensional limit to which superior properties are confined to. The prohibitive costs of most biologics and some small-molecule drugs have led to increased scrutiny in understanding the US government's role in the development of costly novel drug products. Data obtained from industry and the Food and Drug Administration show that most of the approved or pending nanodrugs are oncology-related and based on protein-polymer conjugates or liposomes. The immunogenicity risk profile of a biologic is characterized by measurement of antidrug antibodies levels in patients and correlation with therapeutic outcomes.
