Producing clinical grade stem cell lines
Roslin Cells main activity is the derivation of human embryonic stem cell lines. These lines are derived from surplus embryos gathered as part of IVF programmes. Use of the embryos is subject to strict donor consent and is carried out under licenses from the UK Human Fertilisation and Embryology Authority.
The human embryonic stem cell lines themselves are isolated by fully trained and appropriately qualified staff in Roslin Cells' own cGMP qualified clean rooms. The cells are isolated by processes that ensure that the cells do not come into contact with any animal derived materials.
Once lines are isolated they are quarantined whilst characterisation and Quality Control of the lines is carried out. To maintain cGMP status all processes are carried out to defined protocols and are subject to full documentation.
Before release of any cell lines they are laid down in tightly controlled cell banks and subjected to full Quality Assurance to ensure that lines are the standard expected for clinical or research use.
