Our Sites and Capabilities
Celonic has a state of the art Biologics Development and Innovation Center (BDC) in Basel, Switzerland (headquarters). Clinical and Commercial GMP manufacturing facilities are based in Heidelberg, Germany. At present, more than 500 highly qualified employees work at Celonic.
Our Sites and Capabilities
Celonic has a state of the art Biologics Development and Innovation Center (BDC) in Basel, Switzerland (headquarters). Clinical and Commercial GMP manufacturing facilities are based in Heidelberg, Germany. At present, more than 500 highly qualified employees work at Celonic.
Basel, Switzerland
The Celonic Biologics Development Center (BDC) offers a wide range of services for both development and late phase customer projects. The BDC is the Center of excellence for process and method development as well as process optimization. It can support fed-batch, N-1 perfusion and full perfusion processes up to Pilot Scale (200L Non-GMP).
BDC Services
- Cell Line Development
- Process Development / Optimization
- Method Development
- Pilot scale manufacturing
- Next Generation Technologies
- Technology Transfer
- Process Characterization
- Support for BLA/MAA submissions
Heidelberg, Germany
Celonic has its GMP manufacturing site in the heart of Europe in Heidelberg, Germany. The Small-Scale asset is capable of scales up to 1000L using single use technology and can handle fed-batch, N-1 perfusion and full perfusion production processes. The mid-scale asset offers a state of the art 6x2000L facility set-up offering opportunities to scale up and scale out for commercial supply.
The Celonic Heidelberg facility has an EU good manufacturing practices (cGMP) certification for active biopharmaceutical ingredients (Bio APIs) from cell of human or animal origin as well as for aseptic clinical samples (for analytical tests). The Heidelberg facility is subject to periodic independent inspection by the German Regulatory Body (Regierungspräsidium Tübigen) on behalf of EMA. Furthermore, the site receives numerous yearly visits and audits from clients, and from local and international regulatory authorities.
Multi-Product Small-Scale Asset
- 200L SUB
- 1000L SUB
- Fed-batch / N-1 perfusion / full perfusion
Multi-Product Mid-Scale Asset
- 6x2000L SUB
- Fed-batch / N-1 perfusion