Evidence map›Paper›PMID 39276979›Full record

ArticleJournal of pharmaceutical sciences2024

Current state of nanomedicine drug products: An industry perspective.

Jeffrey D Clogston, Willard Foss, David Harris, Hardeep Oberoi, Jiayi Pan, Elaine Pu, Elisa A Torrico Guzmán, Katrin Walter, Scott Brown, Patrick Lim Soo

Abstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in Journal of pharmaceutical sciences, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 46 papers.

0numbers the graph read from it
0cells of the map it votes in
46citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

46 citing papers in PubMed.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Jeffrey D ClogstonNanotechnology Characterization Lab, Frederick, MD, USA. Electronic address: clogstonj@mail.nih.gov.
Willard FossBristol Myers Squibb, Early Biologics Development, Redwood City, CA, USA.
David HarrisMerck & Co., Inc., Rahway, NJ, 07065, USA.
Hardeep OberoiAbbVie Inc., Drug Product Development, North Chicago, IL, USA.
Jiayi PanBiogen, Technical Development, Cambridge, MA, USA.
Elaine PuBristol Myers Squibb, Drug Product Development, Summit, NJ, USA.
Elisa A Torrico GuzmánVertex Pharmaceuticals, Formulation, Boston, MA, USA.
Katrin WalterAstraZeneca, Pharmaceutical Product Development, Gothenburg, Sweden.
Scott BrownGSK plc. Medicines Development and Supply, Drug Substance and Drug Product Analytical, Collegeville, PA 19426, USA.
Patrick Lim SooPfizer, Pharmaceutical Research & Development, Andover, MA, USA. Electronic address: Patrick.limsoo@pfizer.com.

Funding

WORK ORDER 126643 B539 EXPAND IC SUITE75N91019D00024 · NIAID · LEIDOS BIOMEDICAL RESEARCH, INC. · PI BRISCOE, LYNN · 2019 to 2025
$3932.6M
Intramural NIH HHS Z99 CA999999NCI NIH HHS 75N91019D00024
6 · The paper itself

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.

Indexed as

Drug IndustryNanomedicineCOVID-19Drug ApprovalHumansNanostructuresUnited StatesUnited States Food and Drug AdministrationExcipientsNanoparticlesNanotechnologyPhysicochemical characterizationRegulatorySurvey

Identifiers

PMID39276979
PMCPMC11649492

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.