Drug Substance Development Services

    Experienced hands putting experienced technology to work

    Comprehensive Solutions for Your Biotherapeutic and Vaccine Programs

    At Emergent, our drug substance development teams are ready to work closely with you to deliver a solution honed to your specific needs. We help biopharma organizations in all program phases successfully manage the development and scale-up of cGMP-compliant drug substance processes.

    With more than 20 years of process development experience, Emergent CDMO provides its clients with distinct advantages for their biological programs:

    • Proteins (recombinant, plasma, fusion)
    • Antibodies (mAb, antibody fragments)
    • Viruses (live and live-attenuated)
    • Viral vectors
    • Recombinant viruses 
    • Gene therapy
    • Nanoparticle platforms

    Technologies and Capabilities to Advance Your Program to the Next Level

    Drug Substance Development Capabilities

    • Proprietary A549 cell line for viral production and development
    • Experience with mammalian, microbial, yeast, and insect expression systems
    • Significant experience working with a wide range of viruses (including adenovirus, rVSV, MVA, and baculovirus)
    • Viral vector (AAV) development for gene therapy programs
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    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 and Virus Development Capabilities

    Capability Experience

    Emergent_CDMO_carmine_icons_mammalian_small  Mammalian Cell Lines
    • CHO
    • HEK293
    • Vero
    • PER.C6
    • A549 (adherent and serum-free suspension)
    • ...and more

    Emergent_CDMO_carmine_icons_microbial_small_microbial copie  Microbial Cell Lines
    • Bacteria
      • E. coli
      • B. anthracis
    • Yeast
      • Saccharomyces sp.
      • Pichia sp.

    Emergent_icons_carmine_insect-cell-lines   Insect Cell Lines
    • Sf9
    • S2

    Emergent_CDMO_carmine_icons_viral_small_viral copie  Viruses & Viral Vectors  (Up to BSL2)
    • Adenovirus
    • Adeno-Associated Virus (AAV)
    • Vesiculo-Stomatitis Virus 
    • Herpes Simplex Virus 
    • Influenza Virus
    • Baculovirus
    • Vaccinia/Modified Vaccinia Ankara
    • ...and more

    Drug Substance Development Services

    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
      • 50L single-use fermenter
      • 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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    If you are interested in working with Emergent, want to find out more information about our CDMO services, or would like to have us contact you for any reason, please use this web form to send us your information or questions.