Clinical-grade solution for storage, transportation and administration of cell-based advanced therapy medicinal products
Prior to clinical application, the safety and identity of the cell therapy product must be confirmed by a panel of techniques, recommended by the regulatory authorities. The minimal duration of such procedures comprises 48-72 hrs and in inappropriate conditions such prolonged storage impacts the viability and functional properties of cells.
TECHNOLOGY (INVENTION) DESCRIPTION:
The BTS product is a simple and efficient blend of inorganic components and trehalose, which provides the necessary protection of cell therapy products during 72-96 hrs of hypothermic storage. The specially designed non-toxic composition of the BTS ensures close-to-physiological environment for cells prior to transplantation, providing pH buffering and osmotic support to maintain the ionic balance of cells at low temperatures. These features ensure the preservation of functional properties of cells during quality control studies and transportation to the bedside. The GMP-level BTS product successfully passed the toxicology safety studies that gives the possibility to use it as a vehicle solution or a medical device for the administration of cell-based products to the patient.
ADVANTAGES OVER EXISTING SOLUTIONS:
Among the competitive products available on the world market Hypothermosol-FRS, manufactured by Biolife solutions inc. in USA can be considered as the main competitor. The comparatively simple specially adjusted composition of BTS having the same efficiency as Hypothermosol-FRS offers several major advantages: a) possibility for large-scale production at moderate costs; b) opportunity to apply BTS as a vehicle solution for the administration of cell therapy product to patients in clinical trials; c) the presence of trehalose provides antioxidant properties of the BTS ensuring additional supportive environment for cells after administration into the damaged tissues.
DEVELOPMENT STATUS (STAGE):
GMP-level product underwent GLP toxicological testing for a specific indication and has been validated for clinical use
Petrenko Y, Chudickova M, Vackova I, Groh T, Kosnarova E, Cejkova J, Turnovcova K, Petrenko A, Sykova E, Kubinova S. Clinically Relevant Solution for the Hypothermic Storage and Transportation of Human Multipotent Mesenchymal Stromal Cells. Stem Cells International, vol. 2019, Article ID 5909524, 2019.
IP PROTECTION STATUS:
National Patent. No. 306800 (2017), PCT/IB2017/052832
TECHNOLOGY / IP OWNERS :
National Patent owner: Institute of Experimental Medicine AS CR v.v.i; license purchased by Bioinova Ltd. PCT: Institute of Experimental Medicine AS CR v.v.i and Bioinova Ltd.
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