Contract Development And Manufacturing Of Vaccines, Gene & Immune Therapeutics And Oncolytic Viruses

IDT Biologika is a globally operating biopharmaceutical CDMO that specializes in the contract development and manufacturing of Innovative Vaccines and Cell & Gene Therapeutics.

Our U.S. facility in Rockville, Maryland is close to Washington D.C., the US National Institutes of Health, and is located in a hub for biologics manufacturing.

The site has a long history of contract manufacturing and state-of-the-art technologies used to develop and manufacture clinical trial materials phase I–II for vaccines and cell & gene therapeutics.

We have a Process Development Team in Rockville comprising scientists and engineers highly experienced in complex upstream and downstream processes and with a wide range of different cell lines and viruses. We help our customers overcome challenges with their products by defining the appropriate technologies and employing our experience to refine a process that works and can be scaled.

Our facility offers cell and virus banks, master banks, working banks, master seed stocks and working seed stocks. We also produce bulk drug substance and can provide final formulation and aseptic liquid filling or lyophilization of fill-finish for volumes serving Phase I-II clinical trials. These services are supported by our analytical testing and quality groups.

Our Quality Control and Analytical Development Teams support a wide array of analytical technologies needed to develop novel assays for the characterization, release, and stability testing of early-phase vaccines, gene therapy vectors, and protein therapeutics.