IDT Biologika is investing more than EUR 100 million ($110 million) to expand drug-substance and drug- product manufacturing, visual inspection, and packaging capacities. Dr. Anne Bouchet, Senior Manager, IDT Biologika, outlined the expansion plan at the DCAT Member Company Announcement Forum, which was held March 21, 2022, at DCAT Week 2022.  

The expansion is in response to increasing demand for vaccines, gene and cell therapies, oncolytic viruses and other biologics. The expansion in drug-substance and drug- product manufacturing, visual inspection, and packaging capacities is slated to be fully operational by the second quarter of 2023. Q

The new drug-substance facility will host up to seven production suites with the capacity to hold up to six 2.000-L bioreactors for late-stage and commercial products of live viral vaccines and viral vectors and will provide flexibility in upstream and downstream processing.

IDT Biologika is also scaling up a drug-substance manufacturing suite to the BSL-3 level, including four iCELLIS 500 bioreactors that will be installed to manufacture live virus in adherent cell cultures.

For handling the expected surge in capacity needed for vaccines, IDT Biologika is expanding its fill–finish capacities for 2R, 6R and 10R vials with a further dedicated plant for aseptic liquid filling of late-stage and commercial products up to BSL-2. The line has the capability to fill up to 80 to 100 million 2R vials per year with batch sizes of up to 500,000 2R vials (depending on the bulk volume).

Another investment is the high-performance automated visual inspection equipment with a performance of up to 36,000 vials 2R per hour that will be installed to expand existing visual inspection capabilities and dedicated for large batch sizes and commercial supply.

IDT Biologika has also increased its fill–finish capacities and support for integrated or stand-alone clinical and commercial packaging.