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To provide fill finish services to support the development of live/vectored virus product candidates
October 24, 2016
By: Kristin Brooks
Managing Editor, Contract Pharma
The Biomedical Advanced Research and Development Authority (BARDA) within the office of the Assistant for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) has awarded IDT Biologika an Indefinite Quantity, Indefinite Delivery (IDIQ) contract to provide live virus filling and finishing services with an initial commitment of $100,000, subject to task order(s) for a maximum of $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. The 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 the second provides for rapid response readiness for fill finish services within an accelerated time frame. “We are honored to have been selected by BARDA to receive this contract award and are pleased to support the government efforts to develop vaccine medical countermeasures to address public health threats,” said IDT Biologika chief executive officer Dr. Ralf Pfirmann. “This prime contract with BARDA establishes IDT Biologika’s first opportunity to provide services directly to the US government. Our manufacturing facilities in Germany and Rockville are well positioned to serve BARDA’s current and future requirements.”
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