SOLUTION FOR STORAGE AND TRANSPORTATION OF CELLS
BiCureSolTM
Biological Care Solution
BiCureSolTM - Good Manufacturing Procedure (GMP)-compliant solution of excipients for storage and transportation of cells maintaining cell viability above 92% for at least 72 hours at 2-8 °C.
Appearance: Clear to slightly opalescent sterile solution, free from bacterial endotoxins (<0,25 IU / ml), pH 7,2 to 7,4.
BiCureSol™ allows GMP grade storage of fresh cells (without cryopreservation) at low temperatures (2-8°C) for up to 120 hours without loss of cell number, viability and phenotype without using toxic cryopreservants. Such time period enables a convenient transportation of the fresh Advanced Therapy Medicinal Products (ATMP) from the manufacturer to the clinical sites even at remote destinations.
Our tests showed a clinically relevant quality of mesenchymal stem cells (MSCs) at up to 240 hours (10 days) of storage at 2-8°C.
Background
Therapeutic potential of MSCs has been demonstrated in numerous clinical trials. Usually, freshly harvested cultured cells have been used for applications in regenerative medicine and tissue engineering. The production of MSCs-based ATMPs based compliant with GMP requires number of strictly controlled tests aimed at 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 BiCureSolTM, the time ceases to be an issue.
Mesenchymal stem cells in BiCureSolTM at 2–8 °C
Viability | Phenotype MSC | |
|---|---|---|
92,4% | 99,2% | |
72 hours | 92,2% | 99,0% |
120 hours | 91,9% | 98,5% |
240 hours | 79,7% | 98,6% |