IDT Biologika has dedicated its first U.S. vaccine manufacturing facility in Rockville, MD. The new facility provides a bridge between preclinical development and Phase II clinical trials with capabilities including, process development, cell banking, cGMP manufacturing, purification and formulation, and fill and finish.
The facility is BSL-2 compliant and meets both U.S. FDA and European Medicines Agency (EMA) standards. IDT shares the 75,000-sq.-ft. building with Aeras, a nonprofit, global biotech organization developing new tuberculosis vaccines, and is partnering with Aeras on process development and manufacturing of tuberculosis vaccine candidates.
“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,” said IDT Biologika 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.”IDT Biologika Launches U.S. Vaccine Mfg. Ops
