Method Development

  • Development of robust and compliant assays:
    • Pharmacokinetic (PK)
      • colorimetric
      • fluorescence
      • chemiluminescence
    • Immunogenicity (ADA/Nab)
    • Pharmacodynamic (PD)
  • de novo or transfer
  • Commercial reagent usage
  • Dedicated R&D Team (10+ years experience)

GLP Method Validation

  • Full validation
  • Partial validation
  • Method transfer

GLP ​Sample Analysis

  • Pharmacokinetic (PK)
  • Toxicokinetic (TK)
  • Immunogenicity
    • Antidrug antibody (ADA)
    • Neutralising antibody detection (Nab) 
      • Cell-based
      • Competitive ligand binding
  • Watson LIMS generated results
    • Samples assayed and reported to Sponsor's desired format
Experience includes:
  • Recombinant proteins
  • Monoclonal antibodies
  • Fusion proteins
  • Oligonucleotides
  • Vaccines
  • Biosimilars
  • Biobetters
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