Consequently the decision was taken to build a new production facility comprising demanding process technology such as lyophilisation. Since a fast development of production volume and technology was to be expected in the future the facility had to be flexible enough to accommodate these changes at a minimum of additional investment in full compliance with all pertinent international regulatory requirements.

The limited technical resources in-house required external support going as far as a project realisation on a turnkey basis for the process part. The project was under considerable pressure to meet the demanding timeline and budget requirements.

Key to Success
NNE Pharmaplan AG was selected as contractor for the process part responsible for the project initiation, the subsequent engineering activities, equipment procurement, installation and full qualification from DQ to OQ up to PQ support.

“Key to our success was a clear concept for the facility to be built, based on the process requirements short and medium term combined with the careful choice of suppliers” explains Horst Kellermann, Project Manager from NNE Pharmaplan. “This has enabled us adopt solutions which accommodate the expected evolution with a minimum of cost whilst still ensuring full compliance with all regulatory requirements. The excellent cooperation and support we received from Geistlich throughout the project was another help. Bringing these elements together allowed us to finish the project within the demanding frame set originally”.