IDT Biologika Certifies Facility to Fill and Lyophilize Biologics and Vaccines

IDT Biologika completed and certified the construction of a large-scale production facility dedicated to filling and lyophilization of biologics and vaccine products. The fully integrated facility in Dessau, Germany, uses a sterile liquid-filling line engineered to handle up to 24,000 vials per hour. Certified to biosafety levels 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.

“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,” said Dr. Ralf Pfirmann, CEO of IDT Biologika, in a press release.

Included among the company’s specialized 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.

The new facility further supports the company's development capabilities in live viral vectors increasingly used in the development of novel vaccines. A fully automated loading and unloading freeze-dryer system is now in place for live recombinant and non-recombinant products.

“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,” said Pfirmann.

Source: IDT Biologika