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Enhancing the Stabilization Potential of Lyophilization for Extracellular Vesicles

  • Extracellular vesicles (EV) are an emerging technology as immune therapeutics and drug delivery vehicles. However, EVs are usually stored at −80 °C which limits potential clinical applicability. Freeze-drying of EVs striving for long-term stable formulations is therefore studied. The most appropriate formulation parameters are identified in freeze-thawing studies with two different EV types. After a freeze-drying feasibility study, four lyophilized EV formulations are tested for storage stability for up to 6 months. Freeze-thawing studies revealed improved colloidal EV stability in presence of sucrose or potassium phosphate buffer instead of sodium phosphate buffer or phosphate-buffered saline. Less aggregation and/or vesicle fusion occurred at neutral pH compared to slightly acidic or alkaline pH. EVs colloidal stability can be most effectively preserved by addition of low amounts of poloxamer 188. Polyvinyl pyrrolidone failed to preserve EVs upon freeze-drying. Particle size and concentration of EVs are retained over 6 months at 40 °C in lyophilizates containing 10 mm K- or Na-phosphate buffer, 0.02% poloxamer 188, and 5% sucrose. The biological activity of associated beta-glucuronidase is maintained for 1 month, but decreased after 6 months. Here optimized parameters for lyophilization of EVs that contribute to generate long-term stable EV formulations are presented.

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Document Type:Article
Author:Eduard TrenkenschuhORCiD, Maximilian RichterORCiD, Eilien Heinrich, Marcus Koch, Gregor FuhrmannORCiD, Wolfgang Friess
Parent Title (English):Advanced Healthcare Materials
First Page:2100538
Date of Publication (online):2021/07/26
Year of first Publication:2022
Release Date:2022/05/23
Tag:stability testing
extracellular vesicles; freeze-drying; freeze-thawing; long-term stability; outer membrane vesicles; particle preservation
Impact:11.092 (2021)
Funding Information:Federal Ministry of Research and Education. Grant Number: 13XP5029A; Studienstiftung des Deutschen Volkes
Groups:Physikalische Analytik
DDC classes:500 Naturwissenschaften und Mathematik / 570 Biowissenschaften, Biologie
Open Access:Open Access
Signature:INM 2022/011
Licence (German):License LogoCreative Commons - CC BY-NC-ND - Namensnennung - Nicht kommerziell - Keine Bearbeitungen 4.0 International