ISPE
Contract manufacturer of biopharmaceuticals and vaccines IDT Biologika has announced it is the recipient of the 2015 Facility of the Year Award (FOYA) for facility integration. Sponsored by the International Society for Pharmaceutical Engineering (ISPE), the award spotlights companies that set the standard in pharmaceutical facility design, integration and operational excellence.
Completing a major expansion of its biologics and vaccines production facility in Germany late last year, IDT Biologika established highly automated filling and freeze-drying operations, establishing the basis for large scale commercial manufacturing and increased quality of aseptic operations.
“With this new facility, the company now accommodates production of an ever-more diverse range of biotechnologies with extraordinary precision, safety and integrity,” said Dr. Ralf Pfirmann, IDT’s Chief Executive Officer.
"Designed to be modular, fast and expandable, the IDT Biologika facility is now one of the most flexible biologics operations in the world certified to biosafety levels (BSL) 1 and 2 for live vaccines," said Dr. Andreas Neubert, head of IDT’s business unit vaccines. "Creating a 'future-proof' and flexible production structure has given IDT the leeway it needed to quickly move a number of projects from the incubator, to fill-and-finish, freeze-dry, storage or market with state-of-the-art quality, better economics and operational efficiency.”
"Everyone at IDT Biologika believes this facility is proof that excellence in facility design and integration is a winning formula for the biopharmaceutical supply chain, including the millions of patients around the globe that require access to new and affordable vaccines without delay. Speaking on behalf of the scientists, technicians and facility construction experts at IDT Biologika who made this multipurpose facility a reality, I thank the 2015 FOYA judging panel for recognising this project as vital to the future of affordable biologic medicines," said CEO Dr. Pfirmann.
A major manufacturer of human vaccines designed to address some of the world’s most challenging infectious diseases, IDT Biologika expanded from two to three buildings its vaccine production, extending its capacities for large-scale commercial production of new human vaccines. With a major expansion and integration complete, the company is now equipped to manufacture up to 100 million vials per year of freeze-dried and liquid presentations.
A fully automated large scale loading and unloading freeze-dryer system affords the company a key position for vaccine manufacturing services. A freeze-dryer shelf capacity of 40 m2, equal to at maximum 178,000 vials per batch, complements its production system. Particle and microbiological tests, repeated camera inspections, 100% fill volume controls, vial coding and washing of capped vials assure the highest quality filled vaccines. The new isolator filling line can be expanded with two additional 40 m2 freeze-dryers for scaled-up commercial supply. Furthermore, the building concept allows the implementation of an additional filling line to effectively double manufacturing capacity upon request.
IDT Biologika now offers one of the most dynamic, integrated facilities designed for biomedical product development and manufacturing at one location. The company accommodates the development, testing and manufacture of vital vaccines and other biological products for the world’s leading biopharmaceutical companies.
The ISPE will formally recognise IDT Biologika for facility integration along with winners in other categories during the Facility of the Year Awards Banquet, 2 June 2015, in Washington, D.C.