Emergent BioSolutions Inc. last week announced that it has resumed full manufacturing operations of its anthrax vaccine, BioThrax (Anthrax Vaccine Adsorbed), after completing its internal manufacturing investigation.
The inquiry followed discovery of foreign particles discovered in a limited number of vials in two manufactured BioThrax lots.
Following a comprehensive assessment, the company has identified a supplier component as the most probable root cause. As a result, the company is implementing certain targeted corrective and preventive actions in the operations of its suppliers and contract manufacturers, as well as its own operations.
The company’s investigation concluded that there was no impact to any BioThrax in distribution or to any of the company’s other products or manufacturing operations
With the conclusion of its investigation, Emergent Biosolutions reaffirmed its financial outlook for 2015, forecasting total revenues of $510 to $540 million.