Cell Therapy & Stem Cells
Cleans Cells has very early been committed to the development of Advanced Therapy Medicinal Products (ATMPs) and highly involved in cell therapy as an integrated CRMO.
Our services notably cover the manufacturing of small clinical batches of cell therapy products within the scope of our GMP license to manufacture Investigational Medicinal Products (IMPs).
Our services cover:
- Various cell therapies including human embryonic stem cells (hESCs)
- GMP-qualified grade “A in B” clean rooms
- Full associated and validated safety tests with specific methods for cell therapy products such as sterility testing via Bact/ALERT and mycoplasma detection via qPCR
- Powerful genetic characterization tools (dedicated cytogenetics laboratories)
- Potency testing capabilities [insérer hyperlien]