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    Development, Optimization, and Scale-up

    Expertise and capabilities to fit your drug development needs

    Drug Development Services Built to Run Fast and Smart

    From process optimization, 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.

    Our development services team is comprised of highly-skilled and knowledgeable scientists with decades of experience in drug product development. 

    Through our broad range of capabilities, experience, and resources, Emergent can serve as a strategic partner for your tech transfer, scale up and complex manufacturing needs. 

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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. We help our clients overcome unique product formulation challenges to preserve product integrity and manufacturability for the product lifecycle. 

    Our services include: 

    • 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.