Comprehensive Development Services for Your Most Complex Challenges

    Expertise and capabilities to fit your development needs

    Drug Development Services Built to Run Fast and Smart

    Our comprehensive, integrated suite of development services are designed to sync seamlessly with your team’s specific needs. From process characterization, tech transfer, and scale up, to product characterization, including formulation development and analytical services, we have the capabilities and expertise to help your scientific discovery advance to its next key milestone and beyond.

    Whether your priority is a small production run or a ramp-up to millions of doses of a vaccine or therapeutic, you’ll find our most important drivers at Emergent CDMO are the same as yours — informed creativity, thoughtful strategy, and relentless productivity. 

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    Drug Substance Development

    At Emergent, our drug substance development team designs and characterizes robust, reliable manufacturing processes needed to scale-up, transfer in, and support your drug program from Phase I-III to commercialization. 

    Our clients benefit from our decades of experience working with diverse technology platforms, our best-in-class equipment, and increased automation capabilities to enable a streamlined path from research to final filled product. 

    • Process development and optimization of upstream, recovery and downstream unit operations
    • Process demonstration and scale-up
    • Tech transfer to cGMP manufacturing
    • Drug substance characterization
    • Proprietary A549 cell line for viral production development

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    Drug Product Development

    Our drug product development team is experienced in developing cGMP-compliant drug product processes from early-to late-phase clinical and commercial production for viral and non-viral products. We help our clients overcome unique product formulation challenges to preserve product integrity and manufacturability for the product lifecycle. Our ongoing investment in equipment and instrumentation enhances and automates our drug product development capabilities. 

    • Formulation screening, selection, and optimization services
    • Formulation process development
    • Drug product characterization
    • Lyophilization development
    • Dosage form, container closure, and device selection

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    Analytical Development

    Emergent’s analytical development services are designed to provide the customized and phase-appropriate testing and support needed to meet the specific requirements of your molecule during each stage of development through commercialization.

    • Development of immunology, standard protein, separation, and quantification methods for process support, release, and characterization assays 
    • Method optimization and feasibility studies
    • Technology transfer support
    • Development of cell and immunological methods for potency determination
    • Phase-appropriate validation and characterization testing to support IND or BLA/ANDA
    • Release and stability testing 

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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.