Services:
  • Ligand-binding assay (LBA) method development
  • Method transfer & optimization
  • Pre-study LBA method validation
  • Analysis of study samples from pharmacokinetics (PK), toxicokinetics (TK), pharmacodynamics (PD) and vaccine efficacy studies for:
    • Quantification of protein, peptide and monoclonal antibody based drugs
    • Measurement of biomarkers
    • Detection and characterization of anti-drug antibodies
    • Determination of vaccine potency
Technology Platforms:

At KCAS our dedicated and highly experienced scientists use state-of-the-art Immunoanalytical technologies to support all aspects of large molecule bioanalysis for preclinical and clinical studies (Phase I-IV). Although KCAS is a GLP-compliant laboratory, we also perform rapid bioanalysis for biomarker screening pilot projects where fast turn-around of data may be needed. We pride ourselves in maintaining the human touch while delivering accurate data on time, and at attractive pricing.

  • Enzyme Linked Immunosorbent assay (ELISA) with
    • Colorimetric readout
    • Flourimeteric readout
  • Electrochemiluminescence (ECL)-based assay
  • Cell-based assay
  • Receptor-binding assay
  • Flow Cytometry
PK/TK Support:

Analysis of study samples from PK and TK studies for –

  • Quantification of biologics in animal and human matrices
  • Detection of anti-drug antibodies (Immunogenicity assay)
Immunogenicity Assays:

We use a multi-tiered approach for immunogenicity testing – screening assay for detection, specificity assay for confirmation, titer assay for concentration, isotyping assay for characterization and a cell based bioassay for neutralizing anti-drug antibodies.

Assay types :
  • Bridging assay, sandwich assay, standard ELISA
  • Drug tolerant ECL-based assay
Three-tiered evaluation approach:

1.  Anti-drug antibody (ADA) screening

2.  Positive ADA confirmation

3.  Neutralizing ADA detection

  • Receptor-binding assays
  • Cell-based assays
Vaccine Efficacy/Potency Support:
  • Development of Antibody (Ab) titer assays
  • GLP-compliant validation of Ab titer assays
  • Vaccine efficacy / potency evaluation

Interested in learning more about KCAS’ large molecule services? Fill out the form below and we’ll be in touch shortly!