2008 Facility of the Year Awards Category Winners
IDT Biologika GmbH
Facility of the Year Award Winner in Operational Excellence
IDT Biologika GmbH started contract development and manufacturing activities for newly developed human viral vaccines more than 10 years ago.
In the last decade new technologies were developed based on in house development work considering the latest regulatory demands. Most challenging was safeguarding all operations in a multipurpose facility; excluding cross-contamination and expensive lead time between manufacturing campaigns. Use of disposable technologies, room sterilisation procedures as well as transparency of operations and process flow were major demands to comply with regulatory and client expectations.
These criteria and the operational expertise were used to design the new Facility for Production of Live Human Viral Vaccines IDT 201.
The total production area of 4.698 m² includes two contained manufacturing lines allowing segregated operations for preparation of cells, virus propagation and virus purification using highly efficient technical systems like fermentors and robotic systems. In-process control areas, offices and storage areas complement the manufacturing plant. The building was constructed within 19 months and provides capacities for development and manufacturing of vaccines for clinical trials phase I to III, as well as for commercial supply.
Design and Construction
Clean Room Systems
Automation and BMS