Introducing our newest state-of-the-art facility in Heidelberg, Germany
Our new GMP facility construction “Hall N” includes an expansion of the production capacity at Celonic’s Heidelberg site. Total area of “Hall N” is estimated to have approx. 4,500 square meters with a clean room area of approx. 2,000 square meters.
The planned clean room area will produce mainly biopharmaceuticals for Phase III clinical trials or with regulatory approval. Additionally, the design of the clean rooms will comply with the standards of the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA).
The main process and manufacturing elements will include:
- four cell amplification rooms;
- three upstream production suites (3 x 2,000 L; 3 x 2,000 L; 1 x 1,000 L bioreactors);
- five downstream production suites: three pre-viral and two post-viral;
- scullery and sterilization;
- buffer / media preparation room and clean media.
The planning for “Halle N” started in summer 2018 and it will be fully functional for GMP
production in the second quarter of 2020.