2015 ISPE Facility of the Year Award for Facility Integration
IDT Biologika is an innovative privately‐held company with more than 90 years of experience in research, development, manufacture and distribution of biologics for the global protection of human and animal health. A major manufacturer of human vaccines designed to address some of the world’s most dangerous infectious diseases; IDT Biologika completed and certified the construction of a large‐scale production facility dedicated to filling and lyophilization of biologics and vaccine products. The €40.5MM Multipurpose Biologics and Vaccines Production Facility, incorporating a €12MM isolator for vaccine filling, expands IDT Biologika’s site in Dessau Germany.
- New scalable multi-product facility for manufacturing of future biopharmaceuticals and vaccines. The new scalable multi-product facility for manufacturing of future biopharmaceuticals and vaccines was built to extend and provide capacities for large scale commercial filling and freeze-drying of live human vaccines, with the objectives of flexibility, use of state-of-the-art technology, and comprehensive regulatory compliance. With the completion of this facility, IDT Biologika is equipped to manufacture up to 100 million vials per year of freeze-dried and liquid presentations for growth well into the future.
- Highly automated manufacturing facility for filling and freeze-drying. The highly automated manufacturing facility for filling and freeze-drying is designed to be modular, efficient and expandable. The purposed concept behind the multipurpose facility consists of strict horizontal division of the service areas and the serviced areas. A unique strategy was devised to guarantee the shortest supply and disposal routes. All operations are contained to the extent possible in cleanrooms and in closed technical systems.
- Certified for operations with live recombinant or non-recombinant vaccines up to biosafety level 2. The new facility is certified for operations with live recombinant or nonrecombinant vaccines up to BSL 2. Designed as a multi-product facility, certification for assurance of aseptic processing and containment with control of cross-contamination was a design cornerstone.
- High speed filling line with integrated real time process control and quality assurance technologies for up to 24,000 vials per hour. Designed to meet the future growth potential in vaccine production volumes, driven by increasing health-care market demands, current and future regulatory requirements, and the need to operate efficient state-of-the-art facilities, the new facility integrates a state-of-the-art high speed filling line with integrated real time process control and quality assurance technologies for up to 24,000 vials per hour.
- A fully automated loading and unloading freeze-dryers. Key to the efficiency of the new facility is a fully automated loading and unloading freeze- dryer at shelf capacity of 40m2 each, equal to at maximum 178,000 vials per batch that is fully integrated into the isolator. The fully automated system for loading and unloading is fully automatic, allowing for transfer line by line. The unloading system is segmental with separation possible, allowing for tracing of all segments.