Current state of nanomedicine drug products: An industry perspective

Nanomedicine drug products have reached an unprecedented high in terms of global commercial acceptance and media exposure with the approvals of the mRNA COVID-19 vaccines in 2021. In this paper, we examine the current state of the art for nanomedicine technologies as applied for pharmaceutical produ...

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Bibliographic Details
Published in:Journal of pharmaceutical sciences 2024-12, Vol.113 (12), p.3395-3405
Main Authors: Clogston, Jeffrey D., Foss, Willard, Harris, David, Oberoi, Hardeep, Pan, Jiayi, Pu, Elaine, Guzmán, Elisa A. Torrico, Walter, Katrin, Brown, Scott, Soo, Patrick Lim
Format: Article
Language:English
Subjects:
COVID-19 - prevention & control
Drug Approval
Drug Industry - methods
Excipients
Humans
Nanomedicine - methods
Nanoparticles
Nanostructures - therapeutic use
Nanotechnology
Physicochemical characterization
Regulatory
Survey
United States
United States Food and Drug Administration
Citations: Items that this one cites
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Summary:Nanomedicine drug products have reached an unprecedented high in terms of global commercial acceptance and media exposure with the approvals of the mRNA COVID-19 vaccines in 2021. In this paper, we examine the current state of the art for nanomedicine technologies as applied for pharmaceutical products and compare those trends with results from a recent IQ Consortium industry survey on nanomedicine drug products. We find that 1) industry companies continue to push the envelope in terms of new technologies for characterizing their specific drug products, 2) new analytical technologies continue to be utilized by industry to characterize the increasingly complex nanomedicine drug products and 3) alignment and communication are key between industry and regulatory authorities to better understand the regulatory filings that are being submitted. There are many CMC challenges that a company must overcome to successfully file a nanomedicine drug product. In 2022, the FDA Guidance on Drug Products containing Nanomaterials was published, and it provides a roadmap for submission of a nanomedicine drug product. We propose that our paper serves as a complimentary guide providing knowledge on specific CMC issues such as quality attributes, physicochemical characterization methods, excipients, and stability.
ISSN:0022-3549
1520-6017
1520-6017
DOI:10.1016/j.xphs.2024.09.005