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

Snežana Đorđević, María Medel Gonzalez, Inmaculada Conejos-Sánchez, Barbara Carreira, Sabina Pozzi, Rita C. Acúrcio, Ronit Satchi-Fainaro, Helena F. Florindo, María J. Vicent

Research output: Contribution to journalReview articlepeer-review

Abstract

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: [Figure not available: see fulltext.]

Original languageEnglish
Pages (from-to)500-525
Number of pages26
JournalDrug Delivery and Translational Research
Volume12
Issue number3
DOIs
StatePublished - Mar 2022

Keywords

  • Characterization
  • Manufacturing
  • Nanomedicine translation
  • Regulatory framework
  • Scale-up

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