Monday, 24. October 2016
BARDA Awards IDT Biologika Contract for Live Virus Filling and Finishing Services
Dessau (Germany) and Rockville, Maryland (USA). IDT Biologika, a globally integrated manufacturer of vaccines and biopharmaceuticals, with over 1600 employees worldwide, announces today that the Biomedical Advanced Research and Development Authority (BARDA) within the office of the Assistant for Preparedness and Response (ASPR) at the United States Department of Health and Human Services (HHS) has awarded the company an Indefinite Quantity, Indefinite Delivery (IDIQ) contract to provide live virus filling and finishing services with an initial commitment of US $100,000, subject to task order(s) for a maximum amount of US $50 million. BARDA seeks to establish fill/finish capabilities for use of live-vectored virus products in clinical development through licensure. BARDA has contracted with IDT Biologika to provide services to support cGMP and non-GMP filling and finishing of a variety of medical countermeasure products. The company will initially provide services to support live virus/vectored vaccine fill finish and potentially for small molecule injectables, large molecule sterile injectables, monoclonal antibodies and other development-stage and FDA-approved medical countermeasures.
“We are honored to have been selected by BARDA to receive this contract award and are pleased to support the United States’ government efforts to develop vaccine medical countermeasures to address public health threats,” said IDT Biologika Chief Executive Officer Dr. Ralf Pfirmann. “IDT has performed live virus fill finish services for a variety of customers, including governments, for many years. This prime contract with BARDA is noteworthy, however, as it establishes IDT Biologika’s first opportunity to provide services directly to the US government. Our state-of-art manufacturing facilities located in Germany and Rockville are well positioned to serve BARDA’s current and future requirements.”
The BARDA contract may be performed over a five-year period and addresses two types of requirements: the first being fill finish services to support the development of live/vectored virus product candidates and medical countermeasures. The second provides for rapid response readiness for fill finish services for medical countermeasures within an accelerated time frame.
“The BARDA award showcases IDT Biologika’s global capabilities and highlights the benefits of IDT’s recent expansion in the United States and Canada,” said José Ochoa, Chief Business Officer of IDT Biologika Corporation and BARDA’s primary point of contact at the company. “We look forward to continuing to develop a strong relationship with BARDA and other US government agencies.”