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The stable production and isolation of exosome from human adipose tissue-derived mesenchymal stem cells

      Mesenchymal stem cell-derived exosomes (MSC exosomes), nano-sized (30–200 nm in diameter) extracellular vesicles, are widely recognized as a potential cell-free therapeutic modality since they deliver a variety proteins, nucleic acids, and lipids from MSC. In addition, many studies have been currently on the way to utilize exosomes for diagnosis, drug delivery, and so on. However, large-scale production and isolation of exosomes from conditioned media with high purity is a major obstacle to overcome before development of exosome-based therapeutics. Conventional exosome isolation methods, such as ultracentrifugation, polymer-based precipitation, immunoaffinity purification, and ultrafiltration, have been limited by low purity, low yield, low throughput, or high cost. More importantly, scalability and GMP compliance are major issues that need to be addressed. In the present study, we successfully isolated MSC exosomes with high purity and homogeneity by our proprietary exosome isolation methods. The isolated exosomes were characterized as recommended by the International Society for Extracellular Vesicles (ISEV). To ensure the functionality of isolated exosomes, we also established an in vitro cell-based potency assay. Multiple batches of isolated exosomes can be easily tested and compared with this in vitro assay. Functionality of isolated exosomes is also confirmed through multiple isolations of single batch and multiple campaigns. Taken together, our proprietary method provides stable and scalable isolation of exosome from MSC conditioned media.
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