Quality (philosophy)

Marketing

Product (mathematics)

Process (computing)

Engineering

Philosophy

Nanoparticle

Materials science

Systems engineering

Operating system

Bench to bedside

Medical physics

Computer science

New product development

Risk analysis (engineering)

Drug

Business

Process development

Biochemical engineering

Nanotechnology

Process management

Nanomedicine

Mathematics

Drug development

Epistemology

Pharmacology

Artificial intelligence

Geometry

Quality by Design

Medicine

Consistency (knowledge bases)

Drug Delivery and Translational Research

The field of nanomedicine has significantly influenced research areas such as drug delivery, diagnostics, theranostics, and regenerative medicine; however, the further development of this field will face significant challenges at the regulatory level if related guidance remains unclear and unconsolidated. This review describes those features and pathways crucial to the clinical translation of nanomedicine and highlights considerations for early-stage product development. These include identifying those critical quality attributes of the drug product essential for activity and safety, appropriate analytical methods (physical, chemical, biological) for characterization, important process parameters, and adequate pre-clinical models. Additional concerns include the evaluation of batch-to-batch consistency and considerations regarding scaling up that will ensure a successful reproducible manufacturing process. Furthermore, we advise close collaboration with regulatory agencies from the early stages of development to assure an aligned position to accelerate the development of future nanomedicines. Graphical abstract

Current hurdles to the translation of nanomedicines from bench to the clinic