TY - JOUR
T1 - Current hurdles to the translation of nanomedicines from bench to the clinic
AU - Đorđević, Snežana
AU - Gonzalez, María Medel
AU - Conejos-Sánchez, Inmaculada
AU - Carreira, Barbara
AU - Pozzi, Sabina
AU - Acúrcio, Rita C.
AU - Satchi-Fainaro, Ronit
AU - Florindo, Helena F.
AU - Vicent, María J.
N1 - Publisher Copyright:
© 2021, The Author(s).
PY - 2022/3
Y1 - 2022/3
N2 - 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.]
AB - 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.]
KW - Characterization
KW - Manufacturing
KW - Nanomedicine translation
KW - Regulatory framework
KW - Scale-up
UR - http://www.scopus.com/inward/record.url?scp=85112106781&partnerID=8YFLogxK
U2 - 10.1007/s13346-021-01024-2
DO - 10.1007/s13346-021-01024-2
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C2 - 34302274
AN - SCOPUS:85112106781
SN - 2190-393X
VL - 12
SP - 500
EP - 525
JO - Drug Delivery and Translational Research
JF - Drug Delivery and Translational Research
IS - 3
ER -