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. 2024 Dec;113(12):3395-3405.
doi: 10.1016/j.xphs.2024.09.005. Epub 2024 Sep 12.

Current state of nanomedicine drug products: An industry perspective

Jeffrey D Clogston  1 , Willard Foss  2 , David Harris  3 , Hardeep Oberoi  4 , Jiayi Pan  5 , Elaine Pu  6 , Elisa A Torrico Guzmán  7 , Katrin Walter  8 , Scott Brown  9 , Patrick Lim Soo  10
Affiliations

Current state of nanomedicine drug products: An industry perspective

Jeffrey D Clogston et al. J Pharm Sci. 2024 Dec.

Abstract

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.

Keywords: Excipients; Nanoparticles; Nanotechnology; Physicochemical characterization; Regulatory; Survey.

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Conflict of interest statement

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Figures

Figure 1:
Figure 1:
IQ member survey responses (n=16) for A) Type of Mature Nano Drug Delivery System, B) Therapeutic Indication and C) Route of Administration questions.
Figure 2:
Figure 2:
PharmaCircle™ panoramic search result breakdown for: A) Type of Delivery system; B) Therapeutic Indication; C) Route of Administration; D) Stage of Development
Figure 3:
Figure 3:
Survey results (n=16) for A) Why use a Nano Drug Delivery System (DDS)?, B) Stage of Development that Nano DDS considered as Formulation Strategy?, and C) Factors Preventing Nano DDS Selection questions.
Figure 4:
Figure 4:
Survey results (n=16) breakdown for A) type of excipients used, and B) Challenges and Concerns on Excipients questions.
Figure 5:
Figure 5:
Survey results breakdown for Regulatory: Stage of Development question.
See this image and copyright information in PMC

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