Nanotherapeutics, Inc., a global manufacturer of biodefense and infectious disease products, received two new Task Orders from The U.S. Department of Health and Human Services (HHS), Biomedical Advanced Research and Development Authority (BARDA) Fill-Finish Manufacturing Network’s (FFMN) Pilot Production program.
 
BARDA, in consultation with the FDA’s Drug Shortage Staff, selected several products from the (FDA) Drug Shortage Index, for the network contractors to propose on. Upon completion and successful filing with the regulators at FDA/CDER, this effort will have a potential secondary benefit of increasing fill & finish manufacturing capacity for these products within the U.S. Both Task Orders are for 18 months and include process validation lots and FDA filing.
 
In September 2013, BARDA established the FFMN to facilitate production of clinical investigational lots of various medical countermeasures (MCM) that are in development. At the time, Nanotherapeutics was awarded one of four BARDA contracts to provide filling and finishing capabilities for influenza vaccines and other public health emergency products. Since that time, Nanotherapeutics has also been awarded a Task Order for fill-finish of Mapp Biopharmaceutical’s ZMapp 3-mAb cocktail mix, in clinical development for the treatment of the Ebola Virus Disease.