Emergent BioSolutions, Inc., announced on Tuesday that it will start a new non-clinical efficacy study to demonstrate that BioThrax manufactured at its new plant in Lansing, Michigan, is comparable to the same product produced at its smaller-capacity facility.
The company will use data from the study to support licensure of the new manufacturing facility by the U.S. Food and Drug Administration. BioThrax is the only vaccine licensed by the FDA for the prevention of anthrax disease.
Building 12, also on the company's Lansing campus, produces 7 to 9 million doses of BioThrax annually. The new facility, Building 55, has the potential to triple manufacturing capacity to an estimated 20 to 25 million doses annually.
“In collaboration with FDA, and after having received concurrence on pre-established study endpoints, we are moving forward with a high degree of confidence in this study,” Adam Havey, an executive vice president at Emergent BioSolutions and president of its biodefense division, said.
The company has completed manufacturing BioThrax lots for use in this fifth and final study. Havey said the target date for a rolling submission to the FDA of the supplemental biologics license application, including data from chemistry, manufacturing and controls, is early 2015. The submission would be followed by study data later in the year.