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Analytical Development
Analytical Development

To support development of biologics, Bioworkshops has developed all of the standard analytical methods for physicochemical analysis, bioassays and safety tests that are needed from pre-clinical through to cGMP manufacturing. Our scientists are experienced in method development, qualification and validation and deliver complete methods for product from pre-clinical to cGMP manufacturing.


Primary Structure Advanced Structure Charge Heterogeneity Bioassay Product Related Impurities Process Related Impurities
A.A. sequences Free Thiol N-glycosylation Distribution Binding Affinity Purity Host Cell DNA Residue
Molecular Weight Disulfide Bond Charge Heterogeneity Cell Based Assay Post-Translational Modification Host Cell Protein Residue
N-glycosylation Site Thermostability ADCC/CDC Protein A Residue

Typical Analytical Development

  • 2~3 weeks

    Technology & Materials Transfer

    Doc. Review

    Q & A

    Research materials transfer

  • Physicochemical 3~4 weeks
    Potency 8~12 weeks

    Reproducibility or Development

    Assay Development

    Physicochemical

    ELISA binding

    Cell-based potency

  • 12~16 weeks

    Qualification & Comparability

    Assay Qualification

    Support PD testing

    SOP Drafting

  • 4~8 weeks

    Report & Tech Transfer

    AD Report

    Technology Transfer to QC

    Technology Transfer to Clients