Assessment of bovine milk exosome preparation and lyophilized powder stability

Lu Lu, Chunle Han, Miao Wang, Huanqing Du, Ning Chen, Mengya Gao, Na Wang, Dongli Qi, Wei Bai, Jianxin Yin, Fengwei Dong, Tianshi Li, Xiaohu Ge
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Abstract

Exosomes are cell-derived nanovesicles that play a crucial role in intercellular communication, presenting promising potential as biomarkers and therapeutic agents. Bovine milk exosomes (MK-Exo) show production scalability and cost-effectiveness, offering distinct advantages over cell-derived exosomes. However, exosome storage and transportation are challenging owing to their unstable nature, necessitating preservation at ultralow temperatures. Research findings suggest that freeze-drying could provide a viable solution; however, different sources of exosomes may require specific protocols. In this study, we aimed to successfully isolate high-purity MK-Exo and develop a specialized freeze-drying and lyophilization method for improved long-term preservation of MK-Exo. Specifically, the stability of the lyophilized MK-Exo was evaluated using storage stability tests. Notably, lyophilized MK-Exo remained stable for at least 3 months under high temperature of 50°C and for at least 24 months under low temperatures of 2°C–8°C, preserving their physicochemical properties and biological activity. Conclusively, these findings provide a potential solution for ambient-temperature transportation of MK-Exo, facilitating their industrial-scale production.

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牛乳外泌体制备和冻干粉稳定性评估
外泌体是源自细胞的纳米颗粒,在细胞间通信中发挥着重要作用,具有作为生物标记物和治疗剂的潜力。牛乳外泌体(MK-Exo)具有生产可扩展性和成本效益,与细胞衍生的外泌体相比优势明显。然而,由于外泌体的不稳定性,其储存和运输具有挑战性,必须在超低温下保存。研究结果表明,冷冻干燥可以提供一种可行的解决方案;但是,不同来源的外泌体可能需要特定的方案。在这项研究中,我们旨在成功分离出高纯度的MK-外泌体,并开发出一种专门的冷冻干燥和冻干方法,以改善MK-外泌体的长期保存。具体而言,我们通过储存稳定性测试评估了冻干 MK-Exo 的稳定性。值得注意的是,冻干的 MK-Exo 在 50°C 的高温下至少可稳定保存 3 个月,在 2°C-8°C 的低温下至少可稳定保存 24 个月,其理化性质和生物活性均得以保持。总之,这些发现为 MK-Exo 的常温运输提供了一种潜在的解决方案,有助于其工业化生产。
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