10.07.14
IDT Biologika has completed construction of a large-scale production facility in Dessau, Germany dedicated to filling and lyophilization of biologics and vaccine products. The facility utilizes a sterile liquid filling line engineered to handle as many as 24,000 vials per hour. The facility was designed and commissioned to be used for a range of advanced biomedical technologies required in medium to large clinical stage and commercial stage volumes and is certified to biosafety levels (BSL) 1 and 2 for live vaccines.
Specialized manufacturing capabilities include drug substance and drug product services 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 products produced in the facility can be manufactured in the form of liquid or freeze-dried (lyophilized) presentations.
Also, an automated loading and unloading freeze-dryer system now in place for live recombinant and non-recombinant products along with a freezer-dryer shelf capacity of 40m2, equal to at maximum 178,000 vials per batch.
“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. “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.”
Specialized manufacturing capabilities include drug substance and drug product services 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 products produced in the facility can be manufactured in the form of liquid or freeze-dried (lyophilized) presentations.
Also, an automated loading and unloading freeze-dryer system now in place for live recombinant and non-recombinant products along with a freezer-dryer shelf capacity of 40m2, equal to at maximum 178,000 vials per batch.
“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. “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.”