Emergent BioSolutions Inc.has initiated a non-clinical efficacy study to demonstrate that BioThrax (Anthrax Vaccine Adsorbed) manufactured at large scale in the company's new  facility, Building 55, is comparable to the BioThrax currently manufactured in its approved facility, Building 12. Data from this study will be used to support licensure of Building 55. BioThrax is a vaccine licensed by the US Food and Drug Administration (FDA) for the prevention of anthrax disease.

The company has  completed manufacturing BioThrax lots for use in this fifth and final study required for licensure of the scaled-up manufacture of BioThrax in Building 55. The company is targeting a rolling submission to the FDA of the supplemental biologics license application, including data from chemistry, manufacturing and controls by early next year, followed by data from thisnon-clinical study later in 2015. The primary objectives of this randomized, observer-blinded study are to demonstrate consistency of three BioThrax vaccine lots manufactured in Building 55 based on lot-to-lot equivalence as well as to demonstrate comparability of the three Building 55 lots with a Building 12 lot based on non-inferiority.

Building 12 produces 7 to 9 million doses of BioThrax annually. Building 55 has the potential to triple manufacturing capacity to an estimated 20 to 25 million doses annually. Both facilities are located on Emergent's Lansing, Michigan campus.

This program is fully funded, up to $107 million by the Biomedical Advanced Research and Development Authority within the Office of the Assistant Secretary for Preparedness and Response in the US Department of Health and Human Services.

Source: Emergent BioSolutions