The vaccine manufacturing site in Rockville, Maryland will bridge pre-clinical and Phase II work, including process development, cell banking, cGMP manufacturing, purification and formulation, and fill and finish.
IDT Biologika will share the 75,000 sq ft facility, which meets BSL-2, US FDA, and EMA standards, with Aeras, a global non-profit developing tuberculosis vaccines. The two organisations will work together on process development and manufacturing of TB vaccine candidates.
“With the new facility, we provide U.S. companies with a highly capable and experienced CMO-partner for phase I and phase II clinical vaccine projects right from the heart of the BioMaryland corridor,” said President Ralf Pfirmann.
IDT Biologika GmbH is headquarted in Dessau-Rosslau and performs contract research and manufacturing for human and animal vaccines and biologics. It formed a subsidiary, IDT Biologika Corporation, which acquired the Maryland site in June from Aeras.
Maryland welcomed the German manufacturer to its state. Ben Wu, Deputy Secretary of the Maryland Department of Business and Economic Development, said “IDT Biologika’s decision to locate here is another example of how international companies are viewing Maryland as a prime location for their cutting-edge research and discoveries that are improving the lives of people across the globe.
“Our state is home to many vaccine, biotechnology and pharmaceutical companies, to renowned academic institutions, and to government agencies vital to the development of vaccines.”
At a dedication ceremony yesterday, Pfirmann and Wu were joined by the Mayor of the City of Rockville, Bridget Donnell Newton, the CEO of Aeras, Jacqueline Shea, and representatives from Congress.