IDT Biologika has announced the dedication of its first U.S. vaccine manufacturing facility in Rockville, Maryland. The state-of-the-art facility provides the translational bridge between pre-clinical development and phase II clinical trials with end-to-end capabilities, including process development, cell banking, cGMP manufacturing, purification and formulation, and fill and finish.
“The Rockville facility marks a milestone for IDT Biologika as we expand our worldwide operations into the United States and continue our commitment to meet the vaccine development and production needs in key markets,” says IDT Biologika Corporation President Dr. Ralf Pfirmann. “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.”
The Rockville facility is BSL-2 compliant and meets all U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) standards. IDT Biologika shares the 75,000-foot building with Aeras, a nonprofit, global biotech organization developing new tuberculosis vaccines for the world, and is partnering with the nonprofit organization on process development and manufacturing of candidate tuberculosis vaccines.
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