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KCAS Bioanalytical & Biomarker Services

Shawnee, Kansas, US

KCAS Bioanalytical & Biomarker Services is a bioanalytical and immunoanalytical contract research organization (CRO) with more than 37 years of experience developing and validating robust small molecule, large molecule and biomarker methods for preclinical and clinical studies. Our dedicated scientific and laboratory teams have an average tenure of 14 years, and have developed and validated more than 5,500 bioanalytical assays.

Why KCAS?

  • Expert scientific management has a combined 100+years of bioanalytical testing and laboratory experience
  • Depth and breadth of experience – more than 4,600 proprietary and more than 900 non-proprietary assays developed to date
  • Highly experienced scientific staff with an average tenure of 14 years, builds collaborative partnerships with sponsors
  • Since 1979, we’ve conducted thousands of PK, TK and BA/BE studies
  • Established quantitative, proprietary method for... Show more »

KCAS Bioanalytical & Biomarker Services is a bioanalytical and immunoanalytical contract research organization (CRO) with more than 37 years of experience developing and validating robust small molecule, large molecule and biomarker methods for preclinical and clinical studies. Our dedicated scientific and laboratory teams have an average tenure of 14 years, and have developed and validated more than 5,500 bioanalytical assays.

Why KCAS?

  • Expert scientific management has a combined 100+years of bioanalytical testing and laboratory experience
  • Depth and breadth of experience – more than 4,600 proprietary and more than 900 non-proprietary assays developed to date
  • Highly experienced scientific staff with an average tenure of 14 years, builds collaborative partnerships with sponsors
  • Since 1979, we’ve conducted thousands of PK, TK and BA/BE studies
  • Established quantitative, proprietary method for measurement of menstrual blood loss that is registered with the FDA
  • Progressive SOPs ensure strict regulatory compliance
  • Developed more than 60 peer-reviewed papers
  • 33,000 sq. ft. of dedicated space, centrally located in the Greater Kansas City area
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Minimal Residual Disease (MRD) Testing
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Ultra-Sensitive Simoa Assays
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Quanterix
Small Molecule Bioanalysis
Price on request

Small Molecule Services
Method Development and/or Optimization to improve assay performance
Non-GLP Method Qualification or Full Validation to GLP standards, depending on study needs
Method Transfer for sponsor-supplied methods
High-throughput analysis for clinical and preclinical studies according to GLP and GCP regulations... Show more »

Small Molecule Services
Method Development and/or Optimization to improve assay performance
Non-GLP Method Qualification or Full Validation to GLP standards, depending on study needs
Method Transfer for sponsor-supplied methods
High-throughput analysis for clinical and preclinical studies according to GLP and GCP regulations and guidelines
Customized, bar-coded Clinical PK collection kits for US or global studies
Biorepository services with reliable sample tracking
Expertise
Bioanalysis of chiral compounds, endogenous compounds and biomarkers
Specialists in a variety of biological fluids and hard, soft and complex tissues, including:
Arterial: Pig
Bladder: Dog, Rat
Brain: Monkey, Rat
Emesis: Dog
Feces: Dog, Human, Monkey, Rat
Heart, Liver, Lung, Kidney: Dog, Monkey, Pig, Rat
Nail: Human
Tumor: Human
Skin: Cat, Pig
Sputum: Human
Assays
Validated more than 900 non-proprietary assays (all drug classes)
50+ new methods developed each year
Instrumentation
15 AB Sciex LC-MS/MS systems (5500 QTrap, 5000, 4000, 3000)
Precellys 24 homogenizer
Quality Systems
SOP-driven validations based on current FDA and industry guidance
Incurred sample analysis and outlier analysis SOP
Client’s customized validation protocols
FDA audited and fully compliant

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Human
animal
Whole blood
serum
plasma
Frozen Tissue
LC-MS/MS
all therapeutic areas
Large Molecule Bioanalysis
Price on request

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... Show more »

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
Fluorimetric 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

  1. Positive ADA confirmation

  2. 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

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ELISA automated processing
Mesoscale Discovery Sector S 600
all therapeutic areas
In vivo Immunogenicity Assays
Price on request

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... Show more »

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

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Biomarker Analysis
Price on request

KCAS offers custom and kit-based services for quantifying cytokines, chemokines and other biomarker in animal or human matrices. Our team of scientists use ELISA, or electrochemiluminescence (ECL)-based assays to perform the bulk of our biomarker work, although other platforms, such as LC-MS/MS are available. For ECL-based assays,... Show more »

KCAS offers custom and kit-based services for quantifying cytokines, chemokines and other biomarker in animal or human matrices. Our team of scientists use ELISA, or electrochemiluminescence (ECL)-based assays to perform the bulk of our biomarker work, although other platforms, such as LC-MS/MS are available. For ECL-based assays, we operate the Meso Scale Discovery™ (MSD) Sector Imager 600.

About the MSD Sector Imager 600 platform:
MSD utilizes electrochemiluminescence to detect binding events on patterned arrays. The combination forms a unique solution with the benefits of highly sensitive assays with wide and accurate dynamic ranges, with the additional benefit of convenience. MSD assays can be established in singleplex or multiplex format with 5-10 antigens per well.

The instrument uses ultra-low noise charge-coupled device (CCD) cameras with custom-designed telecentric lenses for rapid detection in all MULTI-ARRAY® or MULTI- SPOT® plates. The reader is ideal for applications requiring high information content and high throughput, making it a perfect platform for multiplexing biomarkers and cytokines or performing immunogenicity screening. To learn more about this instrument visit: Meso Scale Discovery

KCAS provides the following
Need-based method development
Adaptation of commercial kit to fit needs
Method transfer from sponsors’/academic labs
Assay development using critical components
Single-plex and multiplex analysis
Animal and human matrices
Single analyte measurement by ELISA methods
Multiple-analyte panel measurements by ECL–based assays (using MSD Imager 600)
Fit-for purpose method qualification
In-depth knowledge and experience in qualification
Faster analysis, attractive pricing
Nominal-cost qualification of most multiplex panels
Timely deliverables

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Human
animal
Flow Cytometry
ELISA automated processing
Flow cytometry
Mammalian tissue
serum
plasma
ELISA
tissu homogenate
LC-MS/MS
Frozen Tissue
csf
Normal Human tissue
Mesoscale Discovery Sector S 600
anti-drug antibodies (ADA)
ligand binding assays
Fresh Tissue
all therapeutic areas
Solid Tissue
Flow Cytometry
Price on request

KCAS’ flow cytometry team supports the clinical development for biologics and small molecules. Our experienced scientists provide custom assay development, validation, sample processing and consulting services for a wide variety of applications. We pride ourselves on being innovative problem solvers and it’s our top priority to... Show more »

KCAS’ flow cytometry team supports the clinical development for biologics and small molecules. Our experienced scientists provide custom assay development, validation, sample processing and consulting services for a wide variety of applications. We pride ourselves on being innovative problem solvers and it’s our top priority to help clients overcome challenges encountered while developing functional pharmacodynamic assays, live cell assays, isolation of PBMCs, mechanism of action studies, and biomarker assays. Our flow cytometry experts can help with designing the study, performing the assay, and delivering quality data.
Applications
Flow cytometry is a critical tool for monitoring biologics and how they augment the immune system. At KCAS we
use the flow cytometer to monitor phenotype and functionality of white blood cell subsets. Our flow cytometry team has experience measuring a wide range of cells, including T cells, B cells, macrophages/monocytes,
basophils, neutrophils, dendritic cells and proliferation assays (BrdU assays). Researchers utilize flow cytometry for the treatment of patients across a broad range of diseases.
Therapeutic Areas of Expertise:
● Allergy & Asthma
● Autoimmune Disease
● Infectious Disease
● Detection of Minimal Residual Disease (MRD)
● Oncology
● Stem Cell Enumeration
● Transplantation
● Vaccines

Antigen Specific Functional Cells
Tetramer staining and intracellular cytokines
IFN-γ, TNF-α, IL-2, IL-4, IL-17
TBNK (T cell, B cell, & NK cell) Panel
CD3, CD4, CD8, CD16/56, CD19, CD45
T Cell Panels
T Regulatory Cells: CD45, CD4, CD25, CD127
Cytotoxic T Cells: CD3, CD8, CD107
B Cell Panels
Activated B Cells: CD45, CD19, CD20, CD69
Naïve B Cells: CD45, CD19, CD20, CD27neg
Memory B Cells: CD45, CD19, CD20, CD27
Stem Cell Enumeration
CD45, CD34, 7-ADD
Leukemia & Lymphoma Markers
CD2, CD3, CD4, CD5, CD7, CD8, CD10, CD11b,
CD11c, CD13, CD14, CD15, CD16, CD19, CD20,
CD23, CD33, CD34, CD38, CD41, CD45, CD56,
CD64, CD71, CD117, CD138, CD235a, FMC-7,
HLA-DR, kappa, lambda
Toll Like Receptors (TLRs)
Intracellular TLRs: TLR-3, -8, -9
Extracellular TLRs: TLR-1, -2, -4, -5, -6
Activated Basophils
CD45, surface IgE, CD63, CD203c
Cytokines*
Interleukin (IL)-1, IL-2, IL-4, IL-5, IL-6, IL-8, IL-10,
IL-12, IL-13, IL-17, IL-18, IL-23, IFN-γ, TNF-α, TGF-β
*Performed by Meso Scale Discovery Multiplex or ELISA
Diseases
F

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Beckman Coulter
Clinical Sample Kits
Price on request

Some clients need more than just the best bioanalytical sample analysis. To support our clients Research and Development programs, including IND-enabling preclinical and clinical studies, KCAS conducts non-GLP and GLP bioanalysis in a variety of tissues and matrices. With more than 35 years of experience, our expert team adds... Show more »

Some clients need more than just the best bioanalytical sample analysis. To support our clients Research and Development programs, including IND-enabling preclinical and clinical studies, KCAS conducts non-GLP and GLP bioanalysis in a variety of tissues and matrices. With more than 35 years of experience, our expert team adds value to each of our pharma, biotech and CRO clients with a wide range of offerings to ensure sample processing integrity, properly trained clinical sites and regulated long-term sample storage.

Sample Collection Instructions
Protocol guidance for sample processing and shipping instructions
Work with Sponsors and clinical sites to insure a smooth chain of custody transition from clinic to KCAS
Provide pre-labeled collection containers or tubes, pre-labeled sample storage cryovials, shipping containers and other supplies related to sample processing
Design and validate a customized database for specialized sample collection needs
On-Site Study Services
Send trained technicians to clinical site to handle sample processing and shipping to alleviate staffing concerns and ensure the proper care of samples requiring delicate processing.
Monitor clinical sites for sample processing and shipping compliance, allowing the Clinical Research Associate (CRA) to concentrate on subject or patient-related procedures.
For tracking purposes and to provide clients with feedback on clinical site performance, KCAS maintains a historical database of all clinical sites that have shipped samples.
Archive Sample Storage
Long term storage of archive pharmacokinetic (PK) and toxicokinetic (TK) samples refrigerated at -20°C or -70°C

Seven freezers with 140 ft3 capacity for ultra-cold -70°C sample storage
1,540 ft3 walk-in freezer for -20°C sample storage
Triple-redundant temperature records are traceable to National Institute of Standards and Technology standards
All equipment and freezers are monitored by an external vendor, temperature deviations trigger an audible alarm and phone tree notification system

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Whole blood
serum
plasma
Human tumor
Diseased human tissue
Normal Human tissue
all therapeutic areas
Biospecimen Management and Storage
Price on request

ultra-cold -70°C and walk-in freezer for -20°C sample storage
Triple-redundant temperature records are traceable to National Institute of Standards and Technology standards
All equipment and freezers are monitored by an external vendor, temperature deviations trigger an audible alarm and phone tree notification system

ultra-cold -70°C and walk-in freezer for -20°C sample storage
Triple-redundant temperature records are traceable to National Institute of Standards and Technology standards
All equipment and freezers are monitored by an external vendor, temperature deviations trigger an audible alarm and phone tree notification system

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Vaccine Testing Services
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Ligand Binding Assays
Price on request
  • Ligand-binding assay (LBA) method development
  • Method transfer & optimization
  • Pre-study LBA method validation
  • Ligand-binding assay (LBA) method development
  • Method transfer & optimization
  • Pre-study LBA method validation
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Clinical Research
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Clinical Sample Services
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Biology
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Cells and Tissues
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Biospecimens
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Cytometry
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Biochemistry & Molecular Biology
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Biomolecular Interaction Analysis
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Pharmacology & Toxicology
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Toxicology
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In vivo Toxicity Testing
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Bioanalysis
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Drug Discovery & Development
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Drug Discovery
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Vaccines
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Protein Services
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Protein Services

Protein Services

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Protein Purification and Quantification
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Protein Purification and Quantification Services

Protein Purification and Quantification Services

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Protein Quantification
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Protein Quantification Services

Protein Quantification Services

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Clinical Laboratory Services
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Clinical Laboratory Services

Clinical Laboratory Services

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Clinical Molecular Diagnostics
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Clinical Molecular Diagnostics Services

Clinical Molecular Diagnostics Services

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