Gaithersburg

Maryland, USA

At-a-Glance

Our Gaithersburg, MD (USA) facility is a 48,000-sq. ft. two-story building containing laboratories and office space for Emergent's Development Services and associated teams. Our Development Services Center for Excellence offers process development, analytical development, lab-scale manufacturing, and early-phase GMP release and stability testing.

Analytical Development Capabilities and Technologies

Development of methods for process support, release, and characterization assays, including:

  • Immunology-based methods such as ELISA and blotting for detection, quantitation, and purity
  • Separation-based methods for identification, quantitation, and purity, including SDS PAGE, SDS CE, HPLC, CE, and LC-MS
  • Characterization methods for protein quantitation or configuration, including spectrophotometric methods and fluorescence methods
  • Cell-based methods for protein, viral, or adjuvant activity
  • Compendial methods including pH, conductivity, osmolality, and endotoxin

Process Development Capabilities and Technologies

Process Development Capabilities for Drug Substance & Drug Product

  • Process scale-up: develop small-scale models, manufacture at scale
  • Process optimization
  • GMP process development
  • Filtration and chromatography development & optimization
  • Formulation screening, selection & optimization
  • Stability testing
  • Development grade material manufacturing
  • Lyophilization process development, cycle development, and optimization

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