Large Molecule Bioanalysis
2
> 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 reacon Capture Anbody (Ab) Solid Surface Biotech Drug (Analyte) Detecon Ab- Enzyme Conjugate Large Molecule Bioanalysis Our highly experienced sciensts use state-of-the-art immunoanalycal 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 mely, accurate data at a reasonable price. > Protein, pepde and monoclonal anbody based drugs > Measurement of biomarkers > Detecon and characterizaon of an-drug anbodies > Determinaon of vaccine potency > Ligand-binding assay (LBA) method development > Client-provided method transfer and opmizaon > GLP method validaon and full QA support > Analysis of study samples from pharmacokinecs (PK), toxicokinecs (TK), pharmacodynamics (PD) > Quanficaon in animal and human matrices, including ssue Our mul-ered approach to immunogenicity tesng includes, screening the assay for detecon, specificity assay for confirmaon, ter assay for concentraon, and isotyping assay for neutralizing an-drug anbodies. > Bridging assay, sandwich assay, standard ELISA > Drug tolerant ECL-based assay I. An-drug anbody (ADA) screening II. Posive ADA confirmaon III. Neutralizing ADA Detecon - Receptor-binding assays - Cell-based assays KCAS Bioanalycal & Biomarker Services | kcasbio.com | contact us: [email protected] Analysis of study samples from PK/TK studies for: Variety of Assay Plaorms: Three Tiered Evaluaon Approach: Large Molecule Bioanalysis Bioanalycal & Biomarker Services Supported Programs Supported Programs Technology Plaorms PK/TK Methods Immunogenicity Assays
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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
Larg
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Bioa
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sis
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
