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    Drug Product Development Services

    Designed to sync seamlessly with your specific needs

    A Full Suite of cGMP-Compliant Drug Product Development Processes

    With our foundational expertise and comprehensive capabilities in viral and non-viral drug product development, Emergent can help navigate the manufacturing process for your drug product from preclinical development to commercial supply.

    Working with us, you can leverage our broad array of formulation, screening, and optimization platforms, technologies, and equipment to address drug formulation challenges and help ensure process consistency and manufacturability during clinical and commercial phases.

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    A High-Performance Partner to Help Execute Your Drug Product Process Development

    Emergent Bioservices offers the technical capability, experienced personnel, equipment resources, and demonstrated expertise to develop cGMP-compliant formulation processes that preserve product quality.

    • Formulation screening, selection, and optimization
    • Forced degradation and excipient screening studies
    • Drug product characterization
    • Down-selection of liquid versus lyophilization
    • Lyophilization cycle development
    • Dosage form, container closure, and device selection
    • Phase-appropriate analytical services
    • Stability testing under a wide range of conditions
    • Support for toxicity and other IND-enabling studies
    • Regular investments in the latest process development technologies and equipment

    With more than 20 years of process development experience, Emergent Bioservices provides its clients with distinct advantages for their biological programs:
    • Proteins (recombinant, plasma, fusion)
    • Antibodies (mAb, pAb, antibody fragments)
    • Vaccines
    • Recombinant viruses 
    • Enzymes
    • Nanoparticle platforms, including lipid nanoparticles (LNPs)
    • Peptides

    Technologies and Capabilities to Advance Your Program to the Next Level

    Formulation Process Development Lyophilization Development Drug Product Characterization
    • Tank/vessel design
    • Single-use, disposable system for aseptic formulation
    • Mixing studies
    • Order-of-addition studies
    • Filtration process development
    • Process scale-up and optimization
    • Thermal characterization
    • Lyophilization cycle optimization
    • Optimization of product quality
    • Development of lot-production and non-cGMP stability
    • Particle-size distribution
    • Morphology
    • Number density and particulate identification
    • Zeta potential
    • Particulate investigation
    • Protein and virus size and charge 
    • Protein structure

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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.