Large Molecule Bioanalysis

1. > Radioimmunoassay (RIA)
> Enzyme Linked Immunosorbent Assay (ELISA) with
Colorimetric readout and Fluorimetric readout
> Electrochemiluminescence (ECL) based assay
> Receptor-binding assay
Product (colored)
Substrate (colorless)
Enzyme catalyzed
reaction
Capture Antibody (Ab)
Solid Surface
Biotech Drug (Analyte)
Detection Ab-
Enzyme
Conjugate
LargeMoleculeBioanalysis
Our highly experienced scientists use state-of-the-art immunoanalytical technologies to support all aspects of large
molecule bioanalysis for preclinical and clinical studies. Although, KCAS is a GLP-compliant laboratory, we also perform
bioanalysis for biomarker screening pilot projects where fast turn-around of data may be of essence. We pride ourselves
in maintaining the human touch while delivering timely, accurate data at a reasonable price.
> Protein, peptide and monoclonal antibody based drugs
> Measurement of biomarkers
> Detection and characterization of anti-drug antibodies
> Determination of vaccine potency
> Ligand-binding assay (LBA) method development
> Client-provided method transfer and optimization
> GLP method validation and full QA support
> Analysis of study samples from pharmacokinetics
(PK), toxicokinetics (TK), pharmacodynamics (PD)
> Quantification in animal and human matrices,
including tissue
Our multi-tiered approach to immunogenicity testing
includes, screening the assay for detection, specificity
assay for confirmation, titer assay for concentration,
and isotyping assay for neutralizing anti-drug antibodies.
> Bridging assay, sandwich assay, standard ELISA
> Drug tolerant ECL-based assay
I. Anti-drug antibody (ADA) screening
II. Positive ADA confirmation
III. Neutralizing ADA Detection
- Receptor-binding assays
- Cell-based assays
KCAS Bioanalytical & Biomarker Services | kcasbio.com | contact us: info@kcasbio.com
Analysis of study samples from PK/TK studies for:
Variety of Assay Platforms:
Three Tiered Evaluation Approach:
LargeMoleculeBioanalysis
Bioanalytical & Biomarker Services
Supported ProgramsSupported Programs
Technology Platforms
PK/TK Methods
Immunogenicity Assays

2. LargeMoleculeBioanalysis
> In-depth knowledge and experience in biomarker
development and quantification/validation
> Need-based method development
> Adaption of commercial kits to fit needs
> Fit-for-purpose method quantification/validation
> Single-analyte measurement by ELISA/RIA methods
> Multiple-analyte panel measurements by ECL-based
assays using MSD Imager 6000
> Measurements in both animal and human matrices
> Nominal-cost qualification of most multiplex panels
KCAS Bioanalytical & Biomarker Services | kcasbio.com | contact us: info@kcasbio.com
ECL and ELISA Kits or Custom Methodologies
> Neutrophil gelatinase-associated lipocalin (NGAL)
> Rat kidney injury molecule (Kim-1)/T-cell
immunoglobulin (Tim-1)
> Insulin, Glucagon
> Calcitonin, Calcitonin Gene Related Peptide (CGRP),
Substance-P
> TNF α, IFN α, IL-1α, IL-6
> Vitamin D3, PTH
> Tartrate-resistant acid phosphate (TRACP-5b)
> Alkaline phosphatase (ALP), Sclerostin,
Osteoprotegrin (multiplex panel)
> Osteocalcin, Osteopontin, Osteonectin
(multiplex panel)
> N-terminal propeptides of procollagen type 1 (P1NP),
C-telopeptide of type 1 collagen (CTX)
> Development of antibody (Ab) titer assays
> GLP-compliant validation of Ab titer assays
> Vaccine efficacy/potency evaluation
KCAS has an experienced team with a clear understanding
of ICH guidelines and FDA regulations. Our in-house Quality
Assurance (QA) ensures that method development, sample
analysis and reportingare conducted per protocols and
within FDA GLP regulations.
> 33,000 square feet of dedicated space
> ECL MesoScale Imager 6000
> Genalyte Maverick™ Detection System
> ELISA, RIA instruments
> Long-term sample storage
> Global sample collection
> PK sample kit production
> Custom reporting
Bone Metabolism | Human
Renal Injury
Metabolic Disorders
Pro-Inflammation Cytokine Panel
Biomarker Assays Available BiomarkersAvailable Biomarkers
Quality Control and Assurance Facilities & Equipment
Available BiomarkersVaccine Efficacy/Potency Support
LargeMoleculeBioanalysis
Bioanalytical & Biomarker Services