ROCKVILLE, Md.--(BUSINESS WIRE)--IDT Biologika announces today 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"
"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.
"We're very pleased that IDT Biologika, a world-class vaccine manufacturer, has chosen Maryland as the location for its first U.S. manufacturing facility," said Ben Wu, Deputy Secretary of the Maryland Department of Business and Economic Development. "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. Ralf Pfirmann and Mr. Wu, special guests at the dedication ceremony included Bridget Donnell Newton, Mayor, City of Rockville, Jacqueline E. Shea, Ph.D., Chief Executive Officer, Aeras, and representatives from federal congressional offices.
About IDT Biologika
IDT Biologika is an innovative, privately-held life science company with more than 94 years history and expertise in Research, Development and Manufacturing of biologics for the global protection of human and animal health. Headquartered in Dessau-Rosslau, Germany, the company holds an additional animal health vaccine dedicated R&D and Manufacturing location in Greifswald – district Riems. In Denmark, the Netherlands, France, Spain and Canada, IDT's Animal Health Business Unit operates through its own subsidiaries.
In its recently acquired U.S. manufacturing facility in Rockville, Maryland, IDT Biologika Corporation, a subsidiary of IDT Biologika GmbH, primarily works on vaccine development for clinical phase I and II projects and provides early development capabilities for the human vaccine market.
In the 2014 financial year, IDT Biologika GmbH achieved sales of approximately €172 million with its animal health, vaccines, and parenterals, biologics and final drug products packaging business segments, an approximately 14 percent increase in business compared to the previous year. IDT Biologika currently has some 1,500 employees.
IDT Biologika is a company of the Klocke Holding Group. The Klocke Holding Group companies specialize in contract manufacturing and packaging of pharmaceuticals, vaccines, and cosmetic products. With more than 2,100 employees at eight locations in Europe and the USA, the family-owned Klocke Group offers comprehensive services for production and packaging of pharmaceutical products.
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