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Biopharmaceutical Services

Large Molecules, Cell & Gene Therapy Products

Full-Cycle Bio Services

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We provide high quality bioanalytical services including method development, validation, and sample analysis of clinical and non-clinical studies in GLP or non-GLP environments.

Meet Mary Smith

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Quote of timeline integrity for this service area by the Senior Team Leader for this service area.
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Biochemical
Characterization

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  • Molecular weight determination
  • Amino acid composition
  • Glycosylation assay (glycans, sialic acid, mono-saccharide) by Ion Chromatography
  • Replication competent lentivirus (RCL)
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Analytical & Stability Services

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In-vitro cell-based potency assays for monoclonal antibodies, peptides, CGTPs on multiple platforms (Alpha, ABS, Fl and Lum etc.)
  • High content imaging assays
  • Reporter gene assays
  • ADCC, CDC & ADCP assays
  • Customized cell based assays
  • Immunoassays and ligand-binding assays as surrogate potency assay
  • PCR for gene therapy products
  • Customized potency assays
    • Pharmacokinetics and toxicokinetics (PK/TK)
    • Biomarkers
    • Immunogenicity assays:

    Cell Line Services

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    • Cell line screening and optimization
    • Cell culture procedure/medium optimization
    • Master and working cell bank (MCB & WCB) creation for manufacturing purposes
    • MCB, WCB and Assay ready cell bank (ARCB) for analytical purpose
    • Cell bank qualification (purity & functionality)
    • Cell bank storage, inventory management and distribution
    Pipetting in hood aseptic technique
    ddPCR digital droplet PCR

    Analytical & StabilityServices

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    • Pharmacokinetics and toxicokinetics (PK/TK)
    • Biomarkers
    • Immunogenicity assays:
    • Anti-drug antibody analysis: screening, confirmation, and titration
    • Cell bank storage, inventory management and distribution

    Dedication. Quality. Experience.

    Find out how Primera does it better.

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    Dedication. Quality. Experience.

    Find out how Primera does it better.

    Contact Us
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