2025-04-15 バージニア工科大学(VirginiaTech)
<関連情報>
- https://news.vt.edu/articles/2025/04/Research_fralinbiomed_fdexosome_0413.html
- https://jbioleng.biomedcentral.com/articles/10.1186/s13036-024-00470-z
凍結乾燥による乳由来細胞外小胞(mEV)の安定化:長期保存中の構造と生理活性を維持するための新しいトレハロースとトリプトファン製剤 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
Journal of Biological Engineering Published:13 January 2025
DOI:https://doi.org/10.1186/s13036-024-00470-z
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.