The Stability and Storage of Exosome Products: What the Research Says

Exosomes • 23 Jun 2025

Table of Contents

Exosome-based products are gaining momentum in diagnostics, therapeutics, and regenerative medicine, but their clinical and research utility depends on maintaining their stability during storage and handling. Recent research provides important insights into how exosomes can be best preserved to retain their structure, biological activity, and functional cargo.

 

Why Exosome Stability Matters

Exosomes are delicate, biologically active vesicles. Improper storage or repeated handling can damage their membranes, degrade their contents, and diminish their therapeutic or diagnostic efficacy. Stability evaluation is essential for:

  • Ensuring consistent product quality for clinical and research applications
  • Comparing the effectiveness of different exosome preparation and storage methods
  • Meeting regulatory requirements for product development and commercialization1

 

Key Factors Affecting Exosome Stability

1. Preparation Method
Different isolation techniques, such as ultracentrifugation, ultrafiltration, affinity chromatography, and precipitation, yield exosomes with varying degrees of purity and integrity. Some methods may inadvertently damage exosomes, impacting their stability and downstream applications1.

2. Storage Temperature
Temperature is a critical determinant of exosome stability:

  • Room Temperature and 4°C: Short-term storage at 4°C is acceptable for a few days, but exosomes degrade rapidly over longer periods, with losses in protein content and functional activity 2-3-4.
  • −20°C: Offers better preservation than 4°C for short-term storage, but long-term storage still results in decreased quantity and altered size distribution 4-5.
  • −80°C: The consensus for long-term storage. Exosomes remain structurally stable and retain their protein and RNA cargo for months to years when stored at −80°C, with minimal impact from freeze-thaw cycles if handled properly 2-3-4-5.

3. Storage Buffer Composition
Phosphate-buffered saline (PBS) is commonly used, but studies show that exosomes stored in PBS alone can suffer significant losses in recovery and function, especially after freeze-thaw cycles 3-5.

  • Supplementing PBS with human albumin and trehalose (PBS-HAT) or other cryoprotectants like DMSO improves exosome stability, preserves cargo, and enhances recovery after freezing  3-5.

4. Freeze-Thaw Cycles
Repeated freeze-thawing can damage exosome membranes and reduce their bioactivity. While some studies report minimal changes in size after several cycles, others show that freeze-thawing should be minimized to preserve functional integrity, especially for therapeutic use 2-4-5.

5. Storage Duration
Exosomes are stable for at least 3 months at −80°C, and some studies report preservation up to 2 years with optimized buffers and storage conditions 2-3. However, freshly isolated exosomes are always preferred for functional studies and clinical applications 4.

 

Practical Recommendations

  • For short-term storage (up to one week), 4°C may be used, but only if exosomes will be analyzed quickly.
  • For long-term storage, −80°C is strongly recommended, ideally with cryoprotectants like trehalose or human albumin in the buffer to maximize stability and recovery 3-5.
  • Avoid repeated freeze-thaw cycles; aliquot exosome preparations to minimize handling.
  • Use siliconized vessels to prevent exosome adherence to container walls5.
  • Always validate storage protocols for each exosome product and intended application 1-3-5.

 

Conclusion

The stability and storage of exosome products are influenced by isolation method, storage temperature, buffer composition, and handling practices. Research consistently supports −80°C storage with protective additives as the gold standard for preserving exosome integrity and function. As exosome-based therapies and diagnostics move toward mainstream clinical use, rigorous stability evaluation and optimized storage protocols will be essential for ensuring safety, efficacy, and reproducibility.

 

References:
1 Creative Biolabs: Stability Evaluation Service for Exosome Product
2 PMC: Exosomes in bodily fluids are a highly stable resource of disease biomarkers
3 PMC: Identification of storage conditions stabilizing extracellular vesicles
4 PMC: Preservation of small extracellular vesicles for functional analysis
5 Izon Science: How to Store Extracellular Vesicles