Emergent BioSolutions

About

Emergent BioSolutions operates as a leading specialty biopharmaceutical company headquartered in Gaithersburg, Maryland, serving the global healthcare industry through comprehensive contract development and manufacturing organization services. The company specializes in developing vaccines and antibody therapeutics for infectious diseases and opioid overdoses while providing advanced medical devices for biodefense applications. Through its Emergent Bioservices division, the company delivers end-to-end contract manufacturing solutions for bulk drug substances and sterile injectable drug products. Their manufacturing capabilities encompass mammalian and plasma protein technology platforms, supporting complex formulation development including suspensions, viscous solutions, and lyophilization optimization for products with stability challenges. The organization maintains strict adherence to current Good Manufacturing Practice standards across all development phases, implementing Quality by Design principles from early development through commercialization. Emergent BioSolutions brings extensive regulatory compliance experience, having successfully navigated inspections by global regulatory bodies while supporting over 40 commercial products and more than 100 clinical candidates. Their experienced quality control, quality assurance, validation, and document control teams ensure phase-appropriate cGMP compliance throughout their manufacturing network. The company has undergone strategic restructuring, consolidating operations to focus on their advanced facilities in Lansing, Michigan, and Winnipeg, Canada, while maintaining their corporate headquarters and strategic operations in the greater Washington DC metropolitan area. This optimization enhances their ability to serve biopharmaceutical partners with efficient technology transfer capabilities and proven manufacturing expertise in specialty therapeutics and vaccine production.