BiCureSol® is a chemically defined solution for short-term storage and transportation of cells produced under Good Manufacturing Practice (GMP) conditions in category A/B cleanrooms.
BiCureSol® is suitable for storage and transportation of induced pluripotent stem cells, mesenchymal stem cells derived from different tissues (e.g. bone marrow, adipose, umbilical cord, etc.), as well as other cell types (e.g. retinocytes, fibroblasts etc.).
Storage and Transportation Solution for Stem Cells
BiCureSol® allows GMP grade storage of fresh stem cells at low temperatures (2-8 °C) for up to 120 hours while preventing loss in cell number, viability (> 92 %) and phenotype (≥ 98.5 %).
Currently, the application of cells 72 hours after harvesting is approved for clinical use. This time period enables convenient transportation of fresh stem cell-based Advanced Therapy Medicinal Products (ATMP’s) from the manufacturer to the clinical sites even at remote destinations. Importantly, no further manipulation with the ATMP (e.g. washing) is required and the cells can be administered directly.
Significantly, Bioinova’s tests have shown a clinically relevant quality of mesenchymal stem cells (MSCs) even after 240 hours of storage at 2-8 °C (viability 79.7%; stem cell phenotype 98.6 %).
Bone marrow-derived MSCs in BiCureSol® at 2–8 °C
|0 hours||92.4 %||99.2 %|
|72 hours||92.2 %||99.0 %|
|120 hours||91.9 %||98.5 %|
|240 hours||79.7 %||98.6 %|
Production of MSC-based Advanced Therapy Medicinal Products (ATMPs)
The therapeutic potential of MSCs has been demonstrated in numerous clinical trials. Commonly, freshly harvested cultured cells have been used for applications in regenerative medicine and tissue engineering.
The production of MSCs-based Advanced Therapy Medicinal Products (ATMPs) compliant with GMP standards requires a number of strictly controlled tests related to the safety and quality assurance of the product. These include analysis of potential microbial contamination, impurities, phenotyping of the cells, etc. Such testing requires as much as 48-72 hours for reliable results. With this in mind, BiCureSol® was developed to ensure that time ceases to be an issue.
BiCureSol® is a part of the BiCure® ophthalmo MSCs product, an ATMP developed and manufactured by Bioinova, which is currently being evaluated in a clinical trial.
- GMP grade cell storage solution
- Suitable for a wide variety of cell types including fresh stem cells and MSC’s
- Up to 120 hours at low temperatures (2-8 °C)
- Preventing loss in cell numbers
- Viability (> 92 %)
- Phenotype (≥ 98.5 %)
For more information please contact Bioinova today or read more about the product on the company’s website: