New Capacities available
IDT Biologika is responding to the increasing demand for vaccines, oncolytic viruses and other biologics for the health of people worldwide by setting up extensive new capacities in drug substance manufacturing, aseptic liquid fill-finish, automated visual inspection and packaging. We have also raised our production environment to the BSL-3 level. With these exciting investments, we are able to provide our customers’ products even more flexibly, quickly and on an even higher quality standard.
Courtesy of Pall GmbH
Drug Substance Manufacturing
IDT Biologika is moving rapidly with the setting up of an advanced new drug substance manufacturing facility at its company site.
The new vaccine facility houses production rooms with up to six 2.000 L bioreactors for late-stage and commercial products as live viral vaccines, viral vectors for gene and immune therapeutics and oncolytic viruses. It ensures a great flexibility in upstream and downstream technologies.
By enhancing drug substance manufacturing to the BSL-3 level, IDT Biologika also sets a landmark in terms of quality. Four iCELLIS 500® will be installed to manufacture adherent cell cultures up to BSL-3.
Aseptic filling in vials and pre-filled syringes as well as lyophilization of vials are core competencies at IDT Biologika.
For handling the expected surge of capacity needed for vaccines, IDT Biologika is expaning its fill-finish capacities for 2R, 6R and 10R vials by a further dedicated state-of-the-art plant for aseptic liquid filling of late stage and commercial products up to BSL-2.
The line is one of the fastest in the world. With the capability to fill up to 80 to 100 million 2R vials per year and batch sizes of up to 500,000 2R vials (depending on bulk volume) we offer our clients a new contract manufacturing level.
The new high-speed filling line processes active products as
- Viral vector vaccines
- mRNA and DNA vaccines
- Attenuated viral and bacterial vaccines
- Inactivated vaccines
- Toxoid and subunit vaccines
- Virus-like particles
- Biologics such as monoclonal antibodies
- Oncolytic viruses
- Viral vectors for gene and immune therapeutics
A new filling line for pre-filled syringes is also currently designed and will be available in the near future.
A high-performance automatic visual inspection machine with a performance of up to 36,000 vials 2R per hour will be installed to expand our visual inspection capabilities – especially for large batch sizes and commercial supply.
As contract manufacturer for the whole value chain of biologics production, the expanison of our packaging dimensions is a consequential step to the enlargement of our fill-finish capabilities. We support integrated or standalone clinical and commercial packaging.