IDT Biologika, a manufacturer of human vaccines designed to address some of the world’s most dangerous infectious diseases, has completed and certified the construction of a large-scale production facility dedicated to filling and lyophilisation of biologics and vaccine products.
The fully integrated facility in Dessau, Germany, utilises a sterile liquid filling line engineered to handle up to 24,000 vials per hour. Certified to biosafety levels (BSL) 1 and 2 for live vaccines, the facility has been designed and commissioned to be used for a range of advanced biomedical technologies required in medium to large clinical stage and commercial stage volumes.
“Expanding our capabilities within a further multipurpose facility, IDT Biologika now offers one of the most dynamic facilities designed for biomedical products manufacture,” said Dr. Ralf Pfirmann, chief executive officer. “Completion of this project, announced upon start of construction three years ago, allows us to accommodate production of an ever more diverse range of biomedical technologies with the precision and efficiency that comes with a highly integrated and automated facility.”
Included among the company’s specialised manufacturing capabilities are drug substance and drug product capabilities for live recombinant and non-recombinant vaccines and, in separate units, fill-and-finish capabilities for other biologics and small molecule drugs including cytotoxics. All biomedical products produced in the new multipurpose facility may be manufactured in the form of liquid or freeze-dried (lyophilized) presentations.
IDT Biologika’s vaccine development team are experts in live viral vectors increasingly utilised in the development of novel vaccines. The new facility further supports these development capabilities. A fully automated loading and unloading freeze-dryer system now in place for live recombinant and non-recombinant products affords the company a leading manufacturing role in its area of expertise. A freezer-dryer shelf capacity of 40m2, equal to at maximum 178,000 vials per batch, compliments its production system.
“With the completion of this facility, we are equipped to manufacture up to 100 million vials per year of freeze-dried and liquid presentations. Our capacity planning and facility designs appear to be on target, as we gear up to accommodate the development, testing and manufacture of vital vaccines and other biological products for our partners in the biopharmaceutical industries,” Pfirmann said.