Amsbio has announced the launch of GMP-grade Stem Cellbanker, manufactured in strict compliance with Japanese, EU, US, and PICS good manufacturing practice guidelines.
Supplied as a ready-to-use formulation, Stem Cellbanker is a chemically defined freezing solution optimised for stem cell and iPS cell storage as well as preservation of other valuable cells. Recent data supports its unmatched ability for use in cryopreservation of tissues. It is completely free of serum and animal derived component, and contains only US Pharmacopeia, European Pharmacopeia or Japanese Pharmacopeia graded ingredients. A drug master file for the cryopreservation solution has been registered with the US Food and Drug Administration (FDA). [MF # 15785].
Stem Cellbanker significantly increases cell viability while maintaining cell pluripotency, normal karyotype and proliferation ability following resuscitation from cryopreservation, even after extended long-term storage. Independent research has demonstrated that hESC, MSCs and iPS cells cryopreserved with this new solution produce significantly higher cell viability (> 90%) over conventional freezing medium, while retaining cell pluripotency, normal karyotype and proliferation ability. Every batch of Stem Cellbanker cryopreservation medium is performance tested on Jurkat and SK-007 cells. Additional standard evaluations for endotoxins, pH, osmolarity and Mycoplasma contaminants are undertaken to ensure GMP equivalent quality. The product enables long term cell storage for greater than 10 years at -80C or -196C.
