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20+ Years Of Bioanalysis
700+ Small/Large Molecule Studies
450+ Custom Bioanalytical Assays
200+ Investigational Drugs
1,000+ Biomarker & Cytokine Assays

Which Biomarker Assay Development, Biomarker Assay Validation, And Biomarker Analysis Lab Services Do We Offer?

Customized pharmacodynamic biomarkers, cell surface and intracellular antigens, gene expression quantitation, and biomarker analysis CRO services for your therapeutics development!

Multiple Platform Assay Lab Support For Biomarker Testing Services

  • Biomarker Assay Development, Validation, And Sample Analysis Using Elisa, Meso-Scale Discovery, Luminex, qPCR, dPCR, Western Blot, Flow Cytometry, LC-MS, HPLC-UV, And More
  • Ultra-Sensitive Assay Development In Singleplex Or Multiplex Formats To Support Biomarker Services, Biomarker Discovery Services, Pharmacodynamics, Inflammatory Response Studies, And Mechanism Of Action Evaluations

Customized, Multiplex Biomarker Assay Development In Biological Or Formulation Matrices

  • Highly Sensitive And Specific Biomarker Assay Development On Meso Scale Or Luminex Using Commercially Available Assay Kits Or Antibody Pairs, Including In-House Conjugation Services
  • Suitable Assay Development In Relevant Formulation Or Biological Matrices – Plasma, Serum, Cell Culture Supernatants, PBMC, Urine, Tissue Lysates, Cell Lysates, CSF, And More.

Fit-For-Purpose Biomarker Qualification Or GLP Biomarker Assay Validation

  • GLP Biomarker Assay Validation Following GLP Guidelines Using Accredited Equipment And Reagents For Regulated Biomarker Bioanalysis
  • Fit-For-Purpose Method Qualification To Support The Context Of Use (COU) For Your Biomarkers In Exploratory Clinical Endpoints

Comprehensive US-Based Central Lab Services For Biomarker Sample Analysis

  • Customized Clinical Collection Kits, Central Laboratory Services, Long-Term Storage At Room Temperature, Refrigerators, And ULT Freezers
  • High-Throughput Biomarker Sample Preparation For PBMC Preparation, Immunomagnetic Cell Separation, Tissue Lysis, Cell Lysis, Protein Isolation, Nucleic Acid Purification, And Sample Analysis
  • Same-Facility Access To Extensive Biomarker Testing Services Options, Providing Valuable Insights Into Diseases, Treatments, And Biomarker Discovery Services

Safety And Efficacy Pharmacodynamic Biomarker Assay Services

  • PD Biomarker ELISA Immunoassay Services To Confirm The Mechanism Of Action Of Drugs In Clinical Trials
  • Application Of Analytical, Cellular, Or Functional ELISA Assays For Target Identification And Validation

Cell-Based Biomarkers And Pharmacodynamic (PD) Assay Support

  • Proof-Of-Concept Driven, High-Value Cell Culture And Biomarker Assay Development For Activity, Potency, Mechanism Of Action (MOA), Cytotoxicity, And More
  • Biologically Relevant And Reliable Direct And Indirect Cell-Based Assays, Customized For Your Specific PD Biomarker Services Needs, Including Cell Viability, Cell Proliferation, Apoptosis, Signaling, Reporter Gene Expression, And Receptor Binding

Rapid And Reliable Gene Expression/RNA Biomarker Analysis

  • qPCR Assays With Standard Curves And Reference Genes Using Custom Or Pre-Designed Primers And Probes On RNA Isolates From Tissues, Cells, Biofluids, FFPE Samples, And More
  • Multiplex ddPCR Assays To Measure Absolute Expression Levels Of Multiple Target Genes In A Single Reaction, Without The Need For Standard Curves Or Endogenous Controls

Cellular Protein-Based Biomarker Assay Services

  • Latest Platforms And Bioanalytical Methods To Quantify The Levels And Activities Of Specific Proteins In Cells, Such As Cytokines, Receptors, Enzymes, Or Transcription Factors
  • Customized, Fit-For-Purpose Cellular Protein-Based Biomarker Assays Tailored To Your Specific Needs And Antigens, Including Multiplex Assays, Flow Cytometry, And More

Our Biomarker Analysis Experts Have Extensive Experience with the Latest Bioanalytical Technologies!

Chemokine Biomarker Assay

Development And Validation Of V-PLEX/S-PLEX MSD Assays For High-sensitivity Biomarker Analysis In Plasma, Urine, CSF, And Tissues

CRS Assay

Custom U-PLEX MSD Multiplex ELISA Assays For Immune Response And Therapeutic Efficacy Biomarker Measurement In Human Serum

Drug Discovery Biomarker Assays

Compound Screening Using MSD Luminex, Alphalisa, And ELISA To Analyze Biomarkers Testing Services In Cell Culture, Plasma, Serum, And CSF

Impurity/Residual Testing

CRISPR/cas9-based MSD Biomarker Assays For Detecting Residual Materials In Genetic Studies And Therapeutic Production

Cell Based Biomarker Assay

MSD Assay Development, Sample Analysis For Methylated Histones in Monocytes From Human PBMC

TaqMan Gene Expression Assay

Customized Copy Number Multiplex Biomarker Assay on Digital dPCR in DNA Isolates from Human Cell Culture

Relative Gene Expression Assay

qRT-PCR Analysis Of RNA From Non-human Primate Tissues For Accurate Gene Expression Normalization In Preclinical Studies

LI-COR/Western Blot Analysis

Biomarker Assay Development And Analysis Using LI-COR Systems For Multiplex Western Blotting In Tissue And Cell Lysates

Contact A Scientist For Your Biomarker Assay, Biomarker Analysis Services Details

We Will Respond Within 1 Business Day

Comprehensive Suite of Biomarker Analysis Services on Ligand Binding, PCR, and Chromatographic Platforms

Contact Us With Your Cytokine Analysis Or Biomarker Assay

We Will Respond Within 1 Business Day
  • Avoid delays in biomarker development by ensuring no critical aspects are overlooked with flexible and responsive assay services
  • Accelerate your path through regulatory submission with our highly responsive biomarker assay services, minimizing unnecessary delays
  • Benefit from our biomarker discovery expertise to advance therapeutics efficiently, cost-effectively, and at every stage of development

20+

Years Of Biomarker Assay Services With Industry-Leading Turnaround

450+

Biomarker Assays Are Offered Using Commercial Kits Or De Novo Assays Tailored To Your Specific Needs

Expected Services Turnaround

Partner with NorthEast BioLab for expert biomarker analysis in pharmacodynamics and drug discovery. Our team specializes in immunoassays, PCR, cell-based assays, and chromatography, with a proven track record in multiplexing and addressing matrix interference. We deliver biomarker services within 6-8 weeks, followed by an audited report and validation/qualification details. Our expertise ensures resource optimization, cost reduction, and timely progress.

Requested Sponsor Input

We look forward to collaborating with you on your biomarker assay. Our team values transparency and works closely with you to understand your specific requirements. To prepare a detailed proposal and timeline for your project, we request the following information:

  • Analyte(s) of interest
  • Preferred reagents and assay supplies
  • Current assay methodology and any prior biomarker data
  • Study protocols, including details such as the number of cohorts and samples

This information helps us provide an accurate and tailored proposal for your biomarker data analysis needs.

Reviews From Sponsors Of Our Biomarker Assay, Biomarker Analysis Services

Head, Bioanalytical Development

“NorthEast BioLab goes the extra mile. We look forward to more meaningful collaborations.”

Sr. Dir., Bioanalytical Development & QC

NorthEast BioLab offers a science-based, hands-on approach to the latest bioanalytical platforms

VP, Bioanalytical Development

“NorthEast BioLab is the most responsive and thorough bioanalysis lab services CRO.”

VP, Development Operations

NorthEast BioLab’s scientists deliver high-quality data on time and within budget

VP, Biomarker Development 

NorthEast BioLab is a responsive, collaborative, and reliable partner

President & CSO, Biotech

We found their integrity as refreshing as readiness to provide creative scientific input and high-quality data

Contact Us With Your Biomarker Assay

We Will Respond Within 1 Business Day

Expedite Your Ultra-Sensitive Biomarker Multiplex Analysis or Tailored Pharmacodynamic Assay with Our Experts

Extensive Biomarker Assay Development Expertise

  • Upfront Review Of Assay Methods, Biomarker Data, Regulatory Requirements, And Assay Supplies.
  • Expert Optimization And Validation Of Biomarker Assays Using Commercial Supplies.
  • Over 30 Years Of Regulatory Experience, Ensuring Assays Meet The Highest Industry Standards.

Custom Biomarker Assay Services

  • Comprehensive biomarker development with in-house critical reagent tagging (e.G., ruthenylation, biotinylation) for precision and accuracy.
  • Responsive singleplex/multiplex biomarker assays, emphasizing turnaround, flexibility, and transparency.
  • Open communication with senior scientists and sponsors for seamless sample preparation and assay troubleshooting.

List of Biomarker Assay

Biomarker research, discovery, and qualification are pivotal in modern drug development from demonstrating proof-of-concept (POC) to establishing drug safety and …

Our Streamlined Process For On-Time Delivery Of Entire Scope Of Work Within Sponsor Budget

Why Choose Us for Your Biomarker Analysis Services?

20+ Years of Experience with swift and high-value biomarker services assay development, validation, and analysis for preclinical and clinical studies. Our expertise ensures the delivery of high-quality results tailored to your specific research needs.

Contact Us With Your Biomarker Assay

We Will Respond Within 1 Business Day
  • Custom Multiplex Assays For Biomarker Analysis, Including CRS Testing
  • Pharmacodynamic Biomarker Development (PBMCs, DNA/RNA Extracts, Tissue Lysates)
  • Ultra-sensitive Assays With Minimal Sample Volumes For Preclinical/clinical Studies
  • Fit-for-purpose Biomarker Analysis For Therapeutic Monitoring, Mechanism Of Action, Or Compound Screening

Support Your Drug Innovation With Latest Equipment In Safe Hands Of Our Bioanalysis Experts

We Judiciously Invest In Our People, Solutions And Infrastructure, And Regularly Review Our Business Processes And Practices To Exceed Sponsor Expectations

Related FAQs

Answers to additional Biomarker Assay questions popular among our potential sponsors.

What are Biomarkers, and why are they useful?

Biomarkers are measurable indicators of biological processes, conditions, or diseases. They are essential for diagnosing diseases, monitoring disease progression, and assessing the effectiveness of treatments.

What is Biomarker Testing and Analysis?

Biomarker testing and analysis involve using various methods to measure biomarkers in biological samples. This analysis helps identify specific biomarkers related to diseases, drug effects, or therapeutic outcomes.

Which Biomarker Testing Do We Offer?

We offer a wide range of biomarker testing services, including multiplex assays, pharmacodynamic biomarker assays, and gene expression analysis using advanced platforms like ELISA, MSD, Luminex, and LC-MS.

How Do We Perform Biomarker Testing?

Our testing process includes sample collection, biomarker assay development, validation, and quantification using platforms such as qPCR, flow cytometry, and Western blot. We tailor each assay to the needs of the study, ensuring accurate and reliable results.

Which Platforms Are Used For Biomarker Research And Analysis?

We utilize a variety of cutting-edge platforms for biomarker research, including ELISA, Luminex, MSD, qPCR, dPCR, and LC-MS. These technologies allow for highly sensitive and multiplexed analysis, ensuring comprehensive biomarker profiling.

What Is The Need For Biomarker Assay During Drug Development?

Biomarker assays are crucial during drug development for target identification, dose optimization, patient stratification, and monitoring therapeutic efficacy. They provide essential biomarker data on how a drug interacts with its target and the biological system.

What are Biomarker Discovery Services?

Our biomarker discovery services focus on identifying novel biomarkers through genomic, proteomic, and metabolomic profiling. These services support early-phase research and help identify potential biomarkers for disease diagnosis and therapeutic response.

What are Biomarker Development Services?

We provide comprehensive biomarker development services, including assay design, optimization, and qualification. Our goal is to create robust, reproducible assays that can be used for clinical trials or therapeutic monitoring.

What Are Biomarker Validation Services?

Our biomarker validation services ensure that biomarkers perform reliably in real-world scenarios. This includes testing biomarker specificity, sensitivity, and reproducibility across diverse sample types.

What Are Biomarker Qualification Services?

Biomarker qualification services ensure that a biomarker is fit for its intended use in clinical trials or as a diagnostic tool. This process includes evaluating assay performance, accuracy, and clinical relevance.

How Can Biomarker Testing Improve The Drug Development Process?

Biomarker testing accelerates drug development by providing insights into drug efficacy, safety profiles, and optimal patient populations. This leads to more informed decision-making, reducing risks and improving the chances of regulatory approval.

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