The past few years have seen tremendous progress in cell therapeutics, especially the clinical application of stem cells for more than 70 diseases. Cell-based products are regulated as medicines and must comply with GMP guidelines during their production. Cell-based products differ from medicines in several critical aspects:
We can distinguish two classes of stem cell-based products : personalised medicine where isolated stem cells from a patient are re-injected to treat that patient (autologous transplantation) and stem cell drugs developed from stems cells to treat diseases in groups of other patients (allogeneic transplantation).
Stem cell drugs need to be produced according to GMP guidelines which cover matals, production process, validation, standardisation, traceability and training of laboratory personnel.
We help companies to specify, design and audit GMP-compliant stem cell processing facilities.
Links to relevant standards and regulations can be found here.