With the opening of a facility in Rockville, Maryland for vaccine development manufacturing
German life science firm IDT Biologika has commissioned its first US 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 is BSL-2 compliant and meets all US Food and Drug Administration (FDA) and European Medicines Agency (EMA) standards.
IDT Biologika shares the 75,000ft2 (around 7,000m2) building with Aeras, a nonprofit, global biotech organisation developing new tuberculosis vaccines. The two companies will work together on process development and manufacturing of candidate tuberculosis vaccines.
'The Rockville facility marks a milestone for IDT Biologika as we expand our worldwide operations into the US and continue our commitment to meet the vaccine development and production needs in key markets,' said IDT Biologika Corporation President Dr Ralf Pfirmann. 'With the new facility, we provide US 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.'
Ben Wu, Deputy Secretary of the Maryland Department of Business and Economic Development, added: '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.'
In addition to Dr Pfirmann and Wu, special guests at the dedication ceremony included Bridget Donnell Newton, Mayor, City of Rockville, Jacqueline E. Shea, Chief Executive, Aeras, and representatives from federal congressional offices.