We developed a reproducible/scalable isolation methods and Good Manufacturing Practice (GMP)-compliant procedures as required for pharmaceutical products, to obtain a freeze-dried stable and well-defined secretome from mesenchymal stem cell, namely Lyosecretome.
To obtain a standard product, with reproducible features, as required for APIs, a “fingerprint” of Lyosecretome was set up, and we fixed the limits of the product acceptability (proteomic profile and lipid content). Our production follows the typical pharmaceutical approach for the production of biologicals, or extractive phyto-complexes. To list secretome as API or next drug delivery systems or medical device we define standard requirements for isolation, safety, quality and therapeutic purposes.
Our innovative therapeutic approaches combine regenerative stem cell therapy with nanomedicine, thus creating a novel class of “next generation drug delivery systems.”
LYOSECRETOME the powerful driver of cells is now distributed by TwinHelix.
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