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Patent registration for a stem cell storage excipient composition
2020.12.23
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Daehan New Pharm's Bio Research Center registered a patent on December 11 for a composition method of excipients that increase the storage period and survival rate of stem cells.
Cell therapies achieve therapeutic effects by replacing damaged tissues/organs directly or through indirect actions via paracrine and endocrine factors, with ongoing research targeting various intractable diseases. Adult stem cells, especially adipose-derived mesenchymal stem cells, are advantageous due to ethical and safety benefits and ease of isolation with high cell yields.
Unlike conventional drugs, cell therapies consist of living cells, resulting in a very short finished product shelf life of 1–2 days. Cell survival rates during transportation critically affect drug quality, directly limiting market competitiveness. To address these challenges, buffers to increase cell viability and rapid thawing methods post-freezing have been developed. However, toxicity and sterility issues related to commonly used DMSO freezing agents remain problematic.
Daehan New Pharm developed a composition based on approved safe substances to extend storage duration and enhance cell survival rates for finished cell therapy products. Candidate substances including ascorbic acid, PDRN, pyridoxine, and DMEA wereed, and stem cell survival was evaluated over storage periods alongside analysis of post-storage stem cell characteristics. While single treatments of candidates had limited impact, a mixed composition containing ascorbic acid as the base with PDRN, pyridoxine, and DMEA significantly increased cell survival. Cell function was preserved even after more than three days of storage, as confirmed by flow cytometry and differentiation ability tests.
This technology is expected to greatly extend the conventional 24-hour storage period during distribution in commercial stem cell therapies, enhancing product value and competitiveness. It is applicable not only to animal stem cells but also to human stem cells, with potential integration into various products.
The Bio Research Center is dedicated to the efficient culturing, process development, transportation, and storage of stem cells, supporting the commercialization of stem cell therapies. |


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