Our services
Cell Therapy Services
Always close, we are with you all the way on your Cell Therapy Services journey. Together, making advanced biologics, and tomorrow’s life-transforming therapies.
This is affinity in the making.
Rely on our Cell Therapy Services
We provide comprehensive solutions to accelerate the development, manufacturing and commercialization of tomorrow’s life-transforming therapies.
Utilize our significant experience in cell therapy tissue engineering and combined products for autologous and allogeneic applications. Discover how our comprehensive cell therapy solutions can support your efforts at every stage, from research in patients, through development, pre-clinical, clinical, and 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.
With you all the way…
together, making advanced biologics, and tomorrow’s life-transforming therapies.
We deliver unparalleled end-to-end development and manufacturing services for all protein expression systems and viral vectors, both for Drug Substances and Drug Products, from pre-clinical to clinical development and commercial phases.
We support our customers wherever they are on their journey, from early-stage development to commercialization. We are passionate, precise, and always close, together, making advanced biologics and tomorrow’s life-transforming therapies.
Pre-Clinical
Phase I
Phase II
Phase III
Commercial