Large Molecule Bioanalysis
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Transcript of Large Molecule Bioanalysis
> 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-EnzymeConjugate
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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 testingincludes, 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: [email protected]
Analysis of study samples from PK/TK studies for:
Variety of Assay Platforms:
Three Tiered Evaluation Approach:
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Bioanalytical & Biomarker Services
Supported ProgramsSupported Programs
Technology Platforms
PK/TK Methods
Immunogenicity Assays
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> 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: [email protected]
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 SupportLarg
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Bioanalytical & Biomarker Services