In the field of exosome research, some manufacturers employ a preservation technique known as "lyophilization." Lyophilization is essentially a sophisticated drying process that removes water from exosomes through sublimation. This involves first freezing the sample and then applying a vacuum to facilitate the direct transition of water from solid (ice) to gas (vapor).

However, there's a critical drawback to this method. The cell membrane of exosomes includes a delicate structure known as the bilipid layer, which is highly sensitive to such processes. Lyophilization can disrupt this layer, potentially compromising the integrity of the exosomes. While lyophilization allows the exosomes to remain stable at room temperature, rehydrating (or reconstituting) them often doesn’t restore their original chemical structure or functionality.

The process also introduces additional chemicals, leading to a product that isn’t completely pure. From a practical standpoint, lyophilization can create operational inefficiencies and disrupt clinical workflow.

Current scientific evidence does not support the notion that lyophilized exosomes retain the same functional payload, specifically their mRNA and miRNA content, as their non-lyophilized counterparts. No empirical studies in the lyophilized exosome field have yet demonstrated that these vital components remain effective after the process.

For these reasons, our exosome research lab has decided against incorporating lyophilization into our manufacturing process.