IDT Biologika, a German manufacturer of human vaccines and biologics, has completed and certified its €80m large-scale production facility dedicated to filling and lyophilisation of biologics and vaccine products.
The fully integrated facility in Dessau, Germany, includes 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 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 Chief Executive Ralf Pfirmann.
'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.'
We are equipped to manufacture up to 100 million vials per year of freeze-dried and liquid presentations
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 presentations.
The new facility includes a fully automated loading and unloading freeze-dryer system for live recombinant and non-recombinant products. A freezer-dryer shelf capacity of 40m2, equal to a 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,' added Pfirmann.
IDT Biologika has signed up the first customers in Asia, Europe and the US for the aseptic high-speed filling line and staffing levels are being ramped up to accommodate the new capacity.
The company has a second vaccines facility, in Riems in Northern Germany, near the Baltic Sea, where 50 staff are employed. A three-year €12m investment has been made at this facility to expand research and development and quality control.