Drug Substance Development Services

Experienced hands putting experienced technology to work

Applied Experience and Expertise in Drug Substance Process Development

Emergent CDMO offers the technical capability, experienced personnel, equipment resources, and demonstrated expertise to advance your molecule from discovery to commercialization.

  • Process development of upstream, recovery, and downstream operations
  • Process demonstration and scale-up
  • Process characterization to ensure cGMP manufacturing performance
  • Technology transfer and scale-up to cGMP manufacturing
  • Phase-appropriate analytical services
  • Support for toxicology and other IND-enabling studies
  • Single use platforms used in the development phase 
  • Regular investments in the latest process development technologies and equipment

Cell Line Development Expertise

Capability Experience

Emergent_CDMO_carmine_icons_mammalian_small  Mammalian Cell Lines

  • CHO
  • NS0
  • HEK293
  • A549 (adherent and serum-free suspension)
  • Vero
  • MDCK
  • MRC-5
  • PER.C6
  • EB66
  • BHK
  • AGE1.pIX

Drug Substance Development Services

Scalable and Sterile Upstream Development Downstream Development
  • Development of scalable, aseptic upstream process
    • Flask to 250mL Ambr® and iCELLis® nano
    • 10L stirred-tank reactor
    • Shaker flasks, spinner flasks, and flat culture
    • 50L to 200L single-use bioreactors
    • 250mL microbioreactors
    • Perfusion capability
  • Cell and viral development banks
  • Media and feed screening
  • Seed expansion and development
  • Optimization of bioreactor and fermenter operating conditions
  • Downstream processing scales compatible with upstream scale
    • Cell disruption technologies
    • Centrifugation
      • kSep®
      • Disk-stack
    • Depth filtration
    • Tangential Flow Filtration (TFF)
    • Harvest and clarification development
  • Protein and viral purification development
    • High throughput resin screening
    • Column and membrane purification development
      • ÄKTA™ platforms
      • Up to 300cm diameter columns
      • TFF, UF/DF, and formulation
    • Optimization of chromatography conditions
    • Inclusion body isolation and refolding
    • Filter screening

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