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    Analytical Development Services

    Keeping you on-point, on-track, and on-spec

    A Comprehensive Suite of Analytical Development Services

    Emergent’s analytical services are designed to support your clinical program’s success though customized phase-appropriate landmarks specific to your molecule's needs throughout its lifecycle.

    From early development to commercialization, our Analytical Development scientists are here to support you with method development and validation, product characterization, comparability studies, reference standard qualification, and stability and release testing.

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

    Emergent Bioservices offers the technical capability, experienced personnel, equipment resources, and demonstrated expertise to support the development and understanding of your product with a full range of characterization methodologies and assay development.

    • Technology transfer
    • Method development
    • Optimization, feasibility, and robustness studies
    • Development of bio-immuno and complex potency assays
    • Method qualification and validation
    • Early phase release & stability testing
    • Drug substance and drug product characterization testing
    • Validation and characterization testing to support IND and BLA/ANDA submissions
    • 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:

    • Monoclonal Antibodies
    • Antibody Fragments
    • Fusion Proteins
    • Enzymes
    • Recombinant Proteins
    • Nanoparticle Platforms (mRNA-LNP, protein nanoparticles)
    • Viral Platforms (Adeno, MVA, rVSV, VLP)
    • Peptides

    Technologies and Capabilities to Advance Your Program to the Next Level

     

    Chemical Capabilities Biochemical Capabilities Stability Testing Conditions
    • SEC HPLC/UPLC
    • RP HPLC
    • IEX HPLC
    • LC-MS
    • Peptide mapping
    • Oligosaccharide profiling
    • Amino acid analysis
    • FTIR
    • JESS
    • ELISA (titer and impurity)
    • SDS-PAGE and CE SDS
    • Western blotting
    • Total Protein
    • Compendial testing
    • Agarose Gel Electrophoresis
    • PCR, qPCR, and RT-qPCR
    • Potency assays
    • Viral infectivity
    • Routine cell culture capabilities
    • UV-Vis and Fluorescence Spectrophotometry
    • BLI
    • -65 °C and below
    • -40 °C
    • -20 °C
    • -5 °C
    • -25 ˚C
    • -40 ˚C

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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.