Evidence map›Paper›PMID 39806456›Full record

ArticleJournal of biological engineering2025

Stabilizing milk-derived extracellular vesicles (mEVs) through lyophilization: a novel trehalose and tryptophan formulation for maintaining structure and Bioactivity during long-term storage.

Alan B Dogan, Spencer R Marsh, Rachel J Tschetter, Claire E Beard, Md R Amin, L Jane Jourdan, Robert G Gourdie

Abstract read
In one paragraph

Article in Journal of biological engineering, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing 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

21 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

7 authors.

Alan B DoganVirginia Tech Carilion School of Medicine, Roanoke, VA, 24016, USA.
Spencer R MarshFralin Biomedical Research Institute at Virginia Tech Carilion, Roanoke, VA, 24016, USA.
Rachel J TschetterMaterials Science and Engineering, Virginia Tech, Blacksburg, VA, 24061, USA.
Claire E BeardFralin Biomedical Research Institute at Virginia Tech Carilion, Roanoke, VA, 24016, USA.
Md R AminFralin Biomedical Research Institute at Virginia Tech Carilion, Roanoke, VA, 24016, USA.
L Jane JourdanFralin Biomedical Research Institute at Virginia Tech Carilion, Roanoke, VA, 24016, USA.
Robert G GourdieFralin Biomedical Research Institute at Virginia Tech Carilion, Roanoke, VA, 24016, USA. gourdier@vtc.vt.edu.

Funding

Connexin-based Signaling in the Heart: Cellular and ExosomalR35HL161237 · NHLBI · VIRGINIA POLYTECHNIC INST AND ST UNIV · PI ROBERT G GOURDIE · 2022 to 2026
$4.4M
NHLBI NIH HHS R35 HL161237NIH/NHLBI 1R35HL161237-01NSF 2203330Virginia Catalyst grant 1403
6 · The paper itself

Abstract

Extracellular vesicles (EVs) are widely investigated for their implications in cell-cell signaling, immune modulation, disease pathogenesis, cancer, regenerative medicine, and as a potential drug delivery vector. However, maintaining integrity and bioactivity of EVs between Good Manufacturing Practice separation/filtration and end-user application remains a consistent bottleneck towards commercialization. Milk-derived extracellular vesicles (mEVs), separated from bovine milk, could provide a relatively low-cost, scalable platform for large-scale mEV production; however, the reliance on cold supply chain for storage remains a logistical and financial burden for biologics that are unstable at room temperature. Herein, we aim to characterize and engineer a freeze-dried, mEV formulation that can be stored at room temperature without sacrificing structure/bioactivity and can be reconstituted before delivery. In addition to undertaking established mEV assays of structure and function on our preparations, we introduce a novel, efficient, high throughput assay of mEV bioactivity based on Electric Cell Substrate Impedance Sensing (ECIS) in Human dermal fibroblast monolayers. By adding appropriate excipients, such as trehalose and tryptophan, we describe a protective formulation that preserves mEV bioactivity during long-term, room temperature storage. Our identification of the efficacy of tryptophan as a novel additive to mEV lyophilization solutions could represent a significant advancement in stabilizing small extracellular vesicles outside of cold storage conditions.

Indexed as

Bioactivity preservationDrug delivery systemsExtracellular vesiclesFreeze-dryingLyophilizationMilk-derived EVsRoom temperature storageTrehaloseTryptophan

Identifiers

PMID39806456
PMCPMC11727230

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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.