The United States Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) is looking to establish a Fill and Finish Manufacturing Network (FFMN) in the U.S. that facilitates medical countermeasure surge requirements during biodefense emergencies.
These facilities are expected to provide filling and finishing capabilities for influenza vaccines and possibly for pharmaceuticals against CBRN threats or to support fill finishing for other drug shortages.
The effort is intended to create the necessary contractual, business and regulatory relationships with organizations that hold the license for pandemic influenza products to meet the stated HHS objective of having 600 million doses of pandemic influenza vaccine available in 6 months, in response to any pandemic.
It is anticipated that the majority of the time leading up to the fill and finish of 600 million doses will be occupied by viral seed selection and preparation, vaccine bulk drug substance manufacture, reagent development and bulk product release.
At this point, the FFMN will respond in parallel to the filling of pandemic influenza vaccine in finished multi-dose vials with complete internal testing, at the government’s direction.
During non-pandemic periods, a warm-base effort may be executed with Fill and Finish Network members to ensure their capabilities are maintained in a state of readiness.
Initial work under the FFMN contract will be for technology modifications, if necessary, of existing equipment within pharmaceutical fill and finish facilities to meet FDA and cGMP standards for clinical, and Phase 3 Clinical, Commercial-scale fill and finish needs of the government. This phase will also include support to the vaccine owner for submitting a license amendment for this new alternate fill/finish site.
Further details are available under Solicitation Number BARDA-13-100-SOL-00004. Companies have until April 9, 2013 to submit their proposals.