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News|Articles|October 24, 2016
BARDA Contracts IDT Biologika for Live Virus Fill/Finish Services
Author(s)Pharmaceutical Technology Editors
IDT Biologika will provide fill/finish services of live-vectored virus products in clinical development through licensure.
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On Oct. 24, 2016 IDT Biologika announced that the Biomedical Advanced Research and Development Authority (BARDA) has awarded the company an indefinite quantity, indefinite delivery (IDIQ) contract to provide live virus filling and finishing services. The contract includes an initial commitment of $100,000 subject to task order(s) for a maximum amount of $50 million.
According to IDT Biologika, 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 BARDA contract may be performed over a five-year period and addresses two types of requirements: fill/finish services to support the development of live/vectored virus product candidates and medical countermeasures, and rapid response readiness for fill/finish services for medical countermeasures within an accelerated time frame.
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