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Analytical Development
Analytical Development

Bioworkshops has established a battery of in-house analytical platform methods that meet the requirements of physical and chemical analysis, biological activity analysis or safety testing in all stages of biological products from preclinical research to cGMP production. Our researchers have extensive experience in analytical method development and validation.

The analysis platform includes Thermo Orbitrap Exactive HF-X, Protein Simple Maurice, SCIEX PA800 Plus, Waters H-Class UPLC, Thermo Vanquish UHPLC, Thermo CAD detector, Octet intermolecular interaction instrument, MD M5e microplate reader, and Roche 480 qPCR instruments. With this advanced equipment Bioworkshops is able to provide develop and validate analytical methods for comprehensive product characterization, in-process testing, and finish product testing for biologics such as monoclonal antibodies, bi-specific antibodies, fusion proteins, and ADCs.
Primary structure Advanced structure Charge Heterogeneity Bioassay Product Related Impurities Process Related Impurities
A.A sequences Circular Dichroism N-glycosylation distribution Binding affinity Purity (SEC-HPLC、CE-SDS) Host Cell DNA residue
Molecular weight Thermostability Charge heterogeneity Cell based assay Post translational modifications (isomerization, deamidation, oxidation, etc.) Host Cell Protein (HCP) residue
N, C amino acid sequence ADCC/CDC Hydrophobicity profile Protein A (ProA) residue
N-glycosylation Affinity determination Bacterial endotoxin
Free sulfhydryl
Disulfide bond pairing

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

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