Large Molecule
At KCAS our dedicated and highly experienced scientists use state-of-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.
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:
- Radioimmunoassay (RIA)
- Enzyme Linked Immunosorbent assay (ELISA) with
- Colorimetric readout
- Flourimeteric readout
- Electrochemiluminescence (ECL)-based assay
- Cell-based assay
- Receptor-binding assay
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
