Cell Therapy Services
Our team of experts has significant experience in cell therapy, tissue engineering, and combined products for both autologous and allogeneic applications. We are ready to drive your project from development to market supply.
Transfer, development, and tuning services:
– Technology transfer of the process
– Development/optimization of a scalable process
– RCB manufacturing & characterization
– Process scale-up
– Development of freezing methods
– Development of analytical methods
– Stability studies
– Product shipping validation
ATMPs manufacturing services:
– Procurement of starting biological material according to GMP
– Tissue processing, mechanical and enzymatic digestion, immunoselection
– Isolation, culture, and harvest of primary cultures and cell lines; suspension or adherent cells; differentiated and stem cells.
– Cell culture in normoxic or hypoxic conditions.
– Manufacture, characterization, and storage of MCB/WCB.
– Controlled-rate cell freezing.
– Final product formulation
– GMP process validation & GMP certification
– Batch production records and cGMP documentation.
Storage, Distribution, and Delivery:
– Primary packaging: glass vials, cryovials, and bags.
– Labeling of the final container with customized labels
– Cryopreservation under GMP conditions
– Controlled storage at different temperatures: 5°C (±3°C), ‐20°C (±5°C), ‐80°C (±10°C), or less than ‐145°C.
– GMP shipments with validated systems.