NorthEast BioLab Logo | Advanced Bioanalytical Services Lab Agile Bioanalytical Services CRO
  • Expertise
    • Menu IconAll Expertise
    • Menu IconMass Spectrometry (LC-MS)
      • Menu IconMass Spectrometry Services
      • Menu IconHPLC Testing Services
    • Menu IconMeso Scale Discovery Assay
    • Menu IconELISA Assay
      • Menu IconLuminex Multiplex Assay
    • Menu IconFlow Cytometry
    • Menu IconqPCR Analysis, ddPCR Assay
    • Menu IconWestern Blot, In Cell Western
  • Services
    • Menu IconAll Services
    • Menu IconPharmacokinetics (PK) Study
      • Menu IconToxicology (Tox) Study
      • Menu IconDose Formulation Analysis
      • Menu IconPK PD Analysis
      • Menu IconDrug Metabolism and Pharmacokinetics (DMPK)
      • Menu IconADME Studies
      • Menu IconBioequivalence and Bioavailability Studies
    • Menu IconADA Assay, Neutralizing Antibody Assay
    • Menu IconMultiplex Cytokine Assay
    • Menu IconBiomarker Assay
      • Menu IconBiomarker Assay List
    • Menu IconCell-Based Assay
      • Menu IconMechanism of Action (MOA) Studies
      • Menu IconCytotoxicity Assay
      • Menu IconBiochemical Assay
    • Menu IconBioanalytical Assay Validation
  • Solutions
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    • Menu IconClinical CRO
      • Menu IconCentral Lab Services
      • Menu IconPBMC Services
    • Menu IconGLP Laboratory
      • Menu IconBioanalysis
      • Menu IconNon-GLP Testing
    • Menu IconPreclinical CRO
    • Menu IconMethod Development, Validation, And Transfer
      • Menu IconMethod Validation
      • Menu IconMethod Development
      • Menu IconMethod Transfer
    • Menu IconAnalytical Testing
      • Menu IconDiscovery Screening Services
      • Menu IconAnalytical Quantitation
      • Menu IconCosmetic Testing
  • About Us
    • Menu IconAbout Us
    • Menu IconOverview
    • Menu IconLeadership
    • Menu IconFacility and Equipment
    • Menu IconQuality and Compliance
    • Menu IconTherapeutic Areas
    • Menu IconWhy Us?
    • Menu IconValues
    • Menu IconProcess
    • Menu IconPartners
    • Menu IconCareers
      • Business Development Associate
      • Sr. Scientist – Cell Based Assay
      • GLP Quality Assurance Manager
      • Sr. Scientist, ELISA Immunoassay Bioanalysis
      • Sr. Scientist, LC-MS/MS Bioanalysis
      • Associate Scientist, Central Laboratory Services
      • Sr. Scientist - Pharmacokinetics (PK)
      • Content Manager, Scientific and Regulatory Writing
  • Resources
    • Menu IconLearning Center
    • Menu IconBlog
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  • Request Quote
NorthEast BioLab Logo | Advanced Bioanalytical Services Lab Agile Bioanalytical Services CRO Request Quote

Expertise

  • Menu IconAll Expertise
    • Menu IconMass Spectrometry (LC-MS)
      • Menu IconMass Spectrometry Services
      • Menu IconHPLC Testing Services
    • Menu IconMeso Scale Discovery Assay
      • Menu IconELISA Assay
        • Menu IconLuminex Multiplex Assay
      • Menu IconFlow Cytometry
        • Menu IconqPCR Analysis, ddPCR Assay
          • Menu IconWestern Blot, In Cell Western

            Services

            • Menu IconAll Services
              • Menu IconPharmacokinetics (PK) Study
                • Menu IconToxicology (Tox) Study
                • Menu IconDose Formulation Analysis
                • Menu IconPK PD Analysis
                • Menu IconDrug Metabolism and Pharmacokinetics (DMPK)
                • Menu IconADME Studies
                • Menu IconBioequivalence and Bioavailability Studies
              • Menu IconADA Assay, Neutralizing Antibody Assay
                • Menu IconMultiplex Cytokine Assay
                  • Menu IconBiomarker Assay
                    • Menu IconBiomarker Assay List
                  • Menu IconCell-Based Assay
                    • Menu IconMechanism of Action (MOA) Studies
                    • Menu IconCytotoxicity Assay
                    • Menu IconBiochemical Assay
                  • Menu IconBioanalytical Assay Validation

                    Solutions

                    • Menu IconAll Solutions
                      • Menu IconClinical CRO
                        • Menu IconCentral Lab Services
                        • Menu IconPBMC Services
                      • Menu IconGLP Laboratory
                        • Menu IconBioanalysis
                        • Menu IconNon-GLP Testing
                      • Menu IconPreclinical CRO
                        • Menu IconMethod Development, Validation, And Transfer
                          • Menu IconMethod Validation
                          • Menu IconMethod Development
                          • Menu IconMethod Transfer
                        • Menu IconAnalytical Testing
                          • Menu IconDiscovery Screening Services
                          • Menu IconAnalytical Quantitation
                          • Menu IconCosmetic Testing

                        About Us

                        • Menu IconAbout Us
                          • Menu IconOverview
                            • Menu IconLeadership
                              • Menu IconFacility and Equipment
                                • Menu IconQuality and Compliance
                                  • Menu IconTherapeutic Areas
                                    • Menu IconWhy Us?
                                      • Menu IconValues
                                        • Menu IconProcess
                                          • Menu IconPartners
                                            • Menu IconCareers
                                              • Menu IconBusiness Development Associate
                                              • Menu IconSr. Scientist – Cell Based Assay
                                              • Menu IconGLP Quality Assurance Manager
                                              • Menu IconSr. Scientist, ELISA Immunoassay Bioanalysis
                                              • Menu IconSr. Scientist, LC-MS/MS Bioanalysis
                                              • Menu IconAssociate Scientist, Central Laboratory Services
                                              • Menu IconSr. Scientist - Pharmacokinetics (PK)
                                              • Menu IconContent Manager, Scientific and Regulatory Writing

                                            Resources

                                            • Menu IconLearning Center
                                              • Menu IconBlog
                                                • Menu IconCase Study
                                                  • Menu IconVideo Brochures
                                                    • Menu IconNews and Events
                                                      • Menu IconTestimonials
                                                        • Menu IconContact Us

                                                          Request Quote

                                                            Contact Us

                                                            Instrument

                                                            Advanced Bioanalytical Services Lab CRO Trusted By Biotech For Over 20 Years!

                                                            Accelerate Your Bioanalytical Lab Assay CRO Service!

                                                            We Will Respond Within 1 Business Day

                                                            • Full-Service, GLP Bioanalysis For Biologics, Small Molecules, Cell/Gene Therapy
                                                            • Tailored, High-Value PK/PD, ADA/NAb, And Cytokine Bioanalysis Services CRO
                                                            • Preclinical, Clinical Bioanalytical Lab Services At Industry-Leading Turnaround
                                                            • High-Quality Bioanalytical Solutions Using LC-MS, ELISA, And qPCR Assays

                                                            Regulated And Inspected By:

                                                            Good Laboratory Practice for Nonclinical Laboratory Studies | NorthEast BioLab Food and Drug Administration (FDA | NorthEast BioLab Clinical Laboratory Improvement Amendments | NorthEast BioLab International Orgaization for Standardization |NorthEast BioLab
                                                            + Years Of Bioanalysis
                                                            + Small/Large Molecule Studies
                                                            + Custom Bioanalytical Assays
                                                            + Investigational Drugs
                                                            + Biomarker & Cytokine Assays

                                                            Full-Service Bioanalytical Assay Lab For Expedited Drug Development

                                                            Bioanalytical Assay Lab Service

                                                            Pharmacokinetics (PK) Study

                                                            Pharmacokinetics Study, PK Assay, PK CRO Services For Your Small Molecule, Biologics, Cell And Gene Therapy

                                                            Bioanalytical Assay Lab Service

                                                            ADA Assay, NAb Assay

                                                            ADA, TAb/NAb Immunogenicity Assay Service For MAb, Peptide, ADC, Bispecifics, CAR-T,Etc

                                                            Bioanalytical Assay Lab Service

                                                            Multiplex Cytokine Assay

                                                            Multiplex Cytokine Testing Services Using Luminex, MSD ELISA For Your Clinical And Preclinical Studies

                                                            Bioanalytical Assay Lab Service

                                                            Cell Based Assay

                                                            Biologically Relevant Cellular Assay For QC, Potency Testing, MOA Evaluation, Neutralizing Antibody Detection, Etc.

                                                            Bioanalytical Assay Lab Service

                                                            Mass Spec (LC-MS)

                                                            LC MS Method Development, Validation, And Sample Analysis Of Your Therapeutics And Biomarkers

                                                            Bioanalytical Assay Lab Service

                                                            ELISA Service, MSD Assay

                                                            ELISA/MSD Assay Development, ELISA Validation, ELISA Testing Services For Biologics, Vaccines, And Biomarkers

                                                            Bioanalytical Assay Lab Service

                                                            Flow Cytometry Service

                                                            Custom Flow Cytometry Assay For Your Cell Based Immunophenotyping, Immunogenicity, Cytokine Testing

                                                            Bioanalytical Assay Lab Service

                                                            qPCR Analysis, ddPCR Service

                                                            qPCR Analysis, ddPCR Assays For Gene Expression, Copy Number, Vector Biodistribution, And Rare Event Detection

                                                            Accelerate Your Bioanalytical Lab Assay CRO Service!

                                                            We Will Respond Within 1 Business Day

                                                            Bioanalytical Lab Assay

                                                            Comprehensive Bioanalytical CRO Solutions For Small Molecules, Biologics, Antibodies, Vaccines, Cell, And Gene Therapies

                                                            Clinical, Preclinical, And Discovery Phase Bioanalytical Solutions Lab For Biotech And US Government Efforts

                                                            Accelerate Your Bioanalytical Lab Assay CRO Service!

                                                            We Will Respond Within 1 Business Day

                                                            Bioanalytical CRO Solutions Bioanalytical CRO Solutions

                                                            Method Development, Validation, Transfer

                                                            Complete suite of bioanalytical assay lab services, including discovery, GLP, and clinical method development, validation, transfer, and much more

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                                                            Bioanalytical CRO Solutions Bioanalytical CRO Solutions

                                                            GLP Laboratory Services

                                                            FDA, ICH Compliant Good Laboratory Practice (GLP) Bioanalysis Services For Your Smooth Non-Clinical And Clinical GLP Studies Submissions.

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                                                            Bioanalytical CRO Solutions Bioanalytical CRO Solutions

                                                            Clinical CRO
                                                            Services

                                                            Clinical trials CRO and GCLP services from protocol review to submission ready clinical bioanalysis data for biotech and US government sponsors

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                                                            Bioanalytical CRO Solutions Bioanalytical CRO Solutions

                                                            Preclinical CRO Services

                                                            Preclinical CRO trusted by our sponsors to drive GLP preclinical study and Non-GLP preclinical research services for successful IND filing.

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                                                            Bioanalytical CRO Solutions Bioanalytical CRO Solutions

                                                            Analytical Testing Services

                                                            Tailored Analytical Testing And Bioanalytical Laboratory Services For R&D And Formulation Testing Needs Of Biotech, Pharma, And US Government Entities.

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                                                            Bioanalytical CRO Solutions Bioanalytical CRO Solutions

                                                            Non-GLP Bioanalysis Lab

                                                            Expert Non-GLP Study Preclinical Tox (PK/TK), Immunogenicity, And Pharmacodynamic Biomarker Services For Biotech And Academic Investigators.

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                                                            Choose NorthEast BioLab As Your Trusted Bioanalytical CRO!

                                                            Our Bioanalytics Company is a Reliable Choice For All Your Preclinical And Clinical Bioanalysis Services Needs Given Over Two Decades of Hands-On Experience Working With Hundreds Of Novel And Approved Therapeutics.

                                                            • 20+ Years Accelerating Pharmacokinetics (PK/PD), Immunogenicity (ADA/nAb), Cytokine, Biomarkers, And Cell-Based Assays
                                                            • Deep Expertise In Mass Spec, Meso Scale Discovery, ELISA, qPCR/ddPCR, Western Blot, And Other Clinical Bioanalysis Services Platforms
                                                            • GLP/GCLP Compliant Facilities, Successfully Undergone Multiple FDA Audits, And Approved By DEA And CT For Schedule I-IV Bionalysis
                                                            • Committed to Providing Top-Notch Bioanalytical Lab Services Backed By Our Industry Experience, Assay Lab Expertise, And Regulatory Knowledge
                                                            Antibody
                                                            Drug Development Expertise

                                                            Drug Development Expertise

                                                            • Get It Right, The First Time – Veteran Scientists
                                                            • Tailored, High-Quality – Avoid Delays, Budget Overrun
                                                            • Regulatory Awareness – 30+ Years In Life Sciences
                                                            • Diverse Sponsors – Biotech, Fortune 500, NIH, Etc.
                                                            Symbiotic Business Partnership

                                                            Symbiotic Business Partnership

                                                            • Long-Term Horizon – No Study Or Pilot Too Small
                                                            • Attractive Pricing – Value, Proof-of-Concept Focused
                                                            • One-Stop Shop – In-vitro DMPK To GLP/Clinical Studies
                                                            • Solution Provider Mindset – 3rd Party Collaborations
                                                            Distinguished Service Offering

                                                            Distinguished Service Offering

                                                            • Turnaround – ~3-5 Weeks Scheduling, Delivery
                                                            • Flexibility – Free SOW Change Or Expedited Analysis
                                                            • Transparency – Scientist-To-Scientist Communication
                                                            • Sponsor Control – Fine-Tuned Reports Per Feedback
                                                            LEARN MORE ABOUT US

                                                            Sponsors Love Our Bioanalytical Laboratory Services For Top Quality And Industry Leading Turnaround

                                                            Connect With Us For A Reference Call With Them!

                                                            Sponsor
                                                            Head, Bioanalytical Development

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

                                                            Sponsor
                                                            Sr. Dir., Bioanalytical Development & QC

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

                                                            Sponsor
                                                            VP, Bioanalytical Development

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

                                                            Sponsor
                                                            VP, Development Operations

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

                                                            Sponsor
                                                            VP, Biomarker Development 

                                                            NorthEast BioLab is a responsive, collaborative, and reliable partner

                                                            Sponsor
                                                            Executive Director, Pharmacokinetics

                                                            We trust NorthEast BioLab to design and execute streamlined, impactful bioanalytical projects

                                                            Accelerate Your Bioanalytical Lab Assay CRO Service!

                                                            We Will Contact You Within 1 Business Day

                                                            Antybody

                                                            Explore Resource Center To Access Our Bioanalytical Expertise

                                                            Original And Curated Bioanalytical Solutions, Bioanalysis Ideas, And Assay Development Plus Validation Insights

                                                            Learning Center

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                                                            Assay Development

                                                            Assay Development: Types, Processes, & Applications

                                                            Drug discovery and development requires extensive testing, and assays are indispensable. Before we explore how assays are used, let us understand what is an assay, the meaning of assay in biology, and the assay definition in a pharmaceutical context

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                                                            Assay Development

                                                            Cytokines: Their Role in Immunity, Inflammation, and Disease

                                                            Cytokines are an integral part of our immune system that helps us respond to diseases. So, what are cytokines? Let us first define cytokines. These are signaling or immunomodulating molecules released by innate immune cells

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                                                            Assay Development

                                                            Flow Cytometry: Principles, Process, & Applications

                                                            Flow cytometry is a laser-based laboratory bioanalytical technique to detect chemical and physical differences of cells and particles. Since we know what flow cytometry is, let us understand flow cytometry basics and applications of flow cytometry tests in research and healthcare

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                                                            Blog

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                                                            Assay Development

                                                            dPCR vs. Copy Number qPCR in Multiplex CNV Assays

                                                            The Polymerase Chain Reaction (PCR) is an exceptional bioanalytical tool capable of precisely detecting, comparing, and quantifying nucleic acids (RNA or DNA) even at extremely low levels. By exponentially amplifying the starting material millions of times, PCR empowers researchers with unparalleled accuracy and sensitivity

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                                                            Assay Development

                                                            MAb ELISA Protocol, Development, & Bioanalytical Testing

                                                            Monoclonal antibodies (mAbs) are artificially created molecules that imitate the body’s natural antibodies. They are designed to recognize and bind to specific molecules or antigens, and they have diverse applications in therapeutics, diagnostics, and scientific research

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                                                            Assay Development

                                                            Neutralizing Antibody Assay, NAb Assay Service, NAb Analysis

                                                            With the development of many biologics as therapeutics, immunogenicity assessment is an important consideration for patient safety and product efficacy. Among the immunogenicity assessment, Neutralizing Antibody Assays (NAb Assays) have emerged as an indispensable tool, offering nuanced insights into the impact of anti-drug neutralizing antibodies (NAbs)

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                                                            Case Study

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                                                            Assay Development

                                                            Multiplex Cytokine Assay, GLP Validation, & Quantification on MSD

                                                            Develop, optimize, and qualify multiplex immunoassay or cytokine assays for cytokine quantification to assess inflammatory changes of the subjects in different biological matrices utilizing tagged capture-antibodies and ruthenylated detection antibodies on a Meso-Scale Discovery (MSD) platform

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                                                            Assay Development

                                                            MAb FAb PK ELISA Development, GLP Validation, & Bioanalysis

                                                            A biotech sponsor approached us for the development and GLP validation of a PK ELISA specific to their MAb antibody bioanalysis needs. They aimed to quantify a humanized mAb fragment (FAb) targeting a growth factor implicated in a prevalent age-related degenerative disease. The process of MAb ELISA development entails several critical considerations to ensure robust bioanalytical outcomes

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                                                            Assay Development

                                                            Oligonucleotide Hybridization ELISA PK Assay, GLP Validation

                                                            We needed to perform an oligonucleotide assay on a PEGylated RNA aptamer in multiple biological matrices utilizing oligonucleotide hybridization ELISA on Meso Scale Discovery (MSD) platform

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                                                            Video Brochures

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                                                            Assay Development

                                                            Real Time quantitative PCR Services Or droplet digital PCR Assay

                                                            Partner with us for your real time quantitative qPCR analysis and digital dPCR assay services! We offer accurate and reliable detection and quantification of nucleic acids using state-of-the-art technologies. Watch this video to learn more about our qPCR/dPCR capabilities and how they can benefit your research goals

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                                                            Assay Development

                                                            Meso Scale Discovery (MSD): Cytokine Multiplex Assay

                                                            Meso Scale Discovery (MSD) based cytokine multiplex assay development, validation, and sample analysis. Expertise in handling crucial biomarkers such as cytokines, chemokines, and growth factors. Watch the video to learn more about our utilization of S-PLEX, V-PLEX, and R-PLEX kit-based MSD assay services

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                                                            Assay Development

                                                            Meso Scale Discovery: PK/PD and ADA Immunoassay

                                                            Specific and ultra-sensitive MSD-based pharmacokinetics (PK) and anti-drug antibody (ADA) assay services. High value and fit-for-purpose MSD assay services with rapid turnaround time. Watch the video to learn more about our expertise and comprehensive MSD assay solutions

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                                                            FAQs: Our Bioanalysis And Bioanalytical Lab Services

                                                            Answers To Bioanalysis Services And Bioanalytical Lab Services Questions Popular Among Our Potential Clients.

                                                            What are Bioanalytical Services?

                                                            Bioanalytical laboratory services entail the assessment of xenobiotics, biotics, and other analytes of interest in various biological matrices. Specifically, these lab services involve the quantitation of biologics, drugs, metabolites, cytokines, biomarkers, nucleic acids, genes, etc, during integral lab experiments related to therapeutic safety and efficacy. Bioanalytical labs play a crucial role in acquiring essential data during drug research and development, given their extensive portfolio of bioanalytical services such as Pharmacokinetics (PK), ADA Assay, Neutralizing Antibody Assay, Cytokine Analysis, Biomarker Assay, and Bioanalytical Assay Validation. Their deep subject matter expertise and technical know-how ensure accurate analysis and reproducible results, making them an indispensable partner for advancing the patient heath-centric mission of new-age biotechnology companies.

                                                            Why choose us as your PK, ADA, Cytokine, or Cell based Assay Lab?

                                                            At NorthEast BioLab, we are your one-stop solution for all your clinical bioanalysis services, PK, ADA, Cytokine, or Cell based assay bioanalytical testing services needs. With over two decades of experience, our highly skilled experts are prepared to tackle any bioanalytical challenge and provide systematic bioanalytical solutions. Here’s why you should choose us:
                                                            Consistency and Quality: Our experienced team strictly adheres to rigorous protocols and methods, guaranteeing consistent and reliable results. We have successfully executed 600+ PK, ADA, Cytokine, or Cell based assay bioanalysis services, meeting regulatory requirements at every stage. With our robust quality control system, you can trust the accuracy of our data.
                                                            Efficiency and Cost-Effectiveness: By partnering with our bioanalytics company, and its clinical bioanalysis services you can save time and money. We eliminate the hassle of partnering with multiple labs, managing various contracts and invoices, and shipping samples to different facilities. Our competitive pricing structure, economies of scale, and discounts for multiple assays ensure cost-effectiveness. Additionally, our quick turnaround time keeps your project on schedule.
                                                            Innovation and Customization: At NorthEast BioLab, we harness cutting-edge technology and platforms such as LC-MS/MS, ELISA, Meso Scale Discovery, Luminex, QPCR, Digital PCR, and Western Blotting for bioanalysis services. Our dedicated research and development team collaborates with you to develop and validate customized methods tailored to your requirements. We possess various instruments capable of handling diverse sample types, matrices, and analytes.
                                                            We guarantee exceptional results with our state-of-the-art technology, adherence to industry standards, and unwavering commitment to client satisfaction. Contact us today to discuss your bioanalytical needs and get efficient bioanalytical solutions.

                                                            Why Choose a Bioanalytical Assay Lab with broad technology expertise and services?

                                                            You can unlock a world of advantages when partnering with a bioanalytical assay lab offering diverse technological expertise, including LC-MS/MS, ELISA, Meso Scale Discovery, Luminex, QPCR, Digital PCR, and Western Blotting. Our lab provides extensive services, from Cell-Based Assays to Immunogenicity Testing and everything in between.
                                                            When you work with us, you gain access to an impressive selection of bioanalytical methods and platforms tailored to different types of molecules. Whether you need accurate cellular function analyses, drug concentration measurements, inflammatory marker assessments, or immune response evaluations, we have the industry standard and reliable techniques for your project.
                                                            Our skilled lab staff possesses vast experience in bioanalysis services and bioanalytical lab services, allowing them to troubleshoot even the most challenging projects confidently. Rest assured, they’ll guide you through every step of the bioanalytical process and deliver high-quality data and results.
                                                            Choosing our lab will streamline your workflow and save time and money. In other words, no more juggling multiple labs or managing contracts, invoices, and sample shipments. We offer a hassle-free experience, minimizing the risk of delays, errors, and inconsistencies.
                                                            Collaboration is at the heart of what we do. We develop and validate customized and innovative bioanalytical methods based on your needs. Our lab is flexible and creative, ensuring these methods’ robustness, accuracy, and reproducibility to meet regulatory criteria.
                                                            Rest assured, our bioanalytical methods and data adhere to the highest standards set by GLP, FDA, and other regulatory agencies. We follow best practices and maintain an excellent quality management system that guarantees data integrity, security, traceability, and accessibility. Our lab has undergone successful audits and inspections, reaffirming our commitment to excellence.
                                                            Experience the advantages of working with a bioanalytical assay lab renowned for its broad technological expertise and exceptional service offerings. Partner with us today.

                                                            Does NorthEast BioLab offer Biomarker Testing Services?

                                                            Discover the comprehensive biomarker testing services offered by NorthEast BioLab, a leading contract research laboratory. Our state-of-the-art bioanalytical laboratory specializes in biomarker testing services for various therapeutics, including small molecules, biologics, cell therapies, gene therapies, and novel treatments. With over 20 years of experience in the field, we have the expertise and cutting-edge technology to measure drug pharmacodynamic effects, safety, and efficacy.
                                                            Our bioanalysis lab ensures accurate and reliable results with modern analytical platforms like LC-MS/MS, ELISA, Meso Scale Discovery, Luminex, QPCR, Digital PCR, and Western Blotting. Our specialized services include MOA-based pharmacodynamic biomarkers assay and biologically relevant cell-based bioassay, providing valuable mechanistic insights into drug action and disease progression.
                                                            In addition to our advanced testing capabilities, we also offer GLP cytokine analysis for cytokine release syndrome (CRS) and fit-for-purpose assays tailored to meet your specific needs and objectives for each study. Rest assured, our bioanalytical laboratory services adhere to the regulatory guidelines from the FDA, EMA, and other governing agencies.
                                                            Choose our bioanalytics company for all your biomarker testing needs and experience the industry’s highest quality, precision, and compliance levels. Contact us today to discuss your requirements and leverage our expertise for your next research project.

                                                            What are the benefits of working with combined preclinical/clinical bioanalytical services CRO lab?

                                                            Working with a combined preclinical/clinical bioanalytical services CRO lab, such as an assay lab or bioanalytical laboratory, offers numerous benefits:
                                                            It seamlessly transitions from preclinical to clinical studies, saving time and cost.
                                                            It ensures consistency in analytical methods for preclinical and clinical studies, thereby enhancing the reliability of generated data.
                                                            It facilitates a streamlined regulatory process by employing the same analytical methods throughout drug development.
                                                            It promotes improved communication between the preclinical and clinical teams, fostering better decision-making and increased efficiency in drug development.
                                                            Engaging with a contract research laboratory that provides bioanalytical testing services in a GLP-compliant environment significantly enhances the potential for successful outcomes.

                                                            Do you offer large molecule, small molecule, or cell and gene therapy Bioanalytical Services?

                                                            All of the Above! We offer a full suite of bioanalytical services in our US-based, state-of-the-art 19,000 sq ft bioanalytical laboratory. Our gene therapy and large molecule bioanalysis encompass customized bioanalytical assay development and fit-for-purpose or GLP method validation utilizing ELISA, Meso Scale Discovery, Real-Time qPCR, Digital dPCR, and Western Blotting platforms. Additionally, our cell-therapy capabilities extend to Neutralizing Antibody Assay, Cytotoxicity Assay, Biochemical Assay, and Mechanism Of Action (MoA) studies.

                                                            Our small molecule bioanalysis includes mass spectrometry and HPLC lab with deep expertise in PK PD Analysis, DMPK, ADME Studies, Tox (TK) Study, and Biomarker Assay. Trust our bioanalytical lab with 20+ years track record on 600+ bioanalysis studies to generate reliable and reproducible data for your IND package and NDA submission.

                                                            Do you develop new methods or transfer and validate existing methods during Bioanalytical Services?

                                                            Both! NorthEast BioAnlaytical Laboratory provides comprehensive bioanalytical services covering method development, transfer, and validation. We perform rapid method development by optimizing sample preparation and other bioanalytical assay components as needed for the targeted calibration range and acceptance criteria. Our bioanalytical experts excel in method transfer between labs, personnel, and equipment. If required, we gladly adjust your method for straightforward validation or if the method transfer fails due to incomplete or incorrect information.

                                                            Our reliable bioanalytical services ensure reliable and reproducible measurements of your analytes in a given biological matrix. Following FDA/EMA/ICH guidelines, we run full three-day LC-MS/MS or six-day ELISA method validation to evaluate precision and accuracy. Subsequently, our assays examine selectivity, specificity, recovery, carryover, matrix effect, and process stability. Ultimately, we assess long-term storage stability for your therapeutics and biomarkers. Trust our premium bioanalytical lab for efficient and precise analysis of your crucial samples.

                                                            How do I estimate the budget for my Bioanalytical Services needs?

                                                            NorthEast BioAnalytical Lab is differentiated as the unwavering provider of comprehensive bioanalytical services with over 20 years of expertise and industry leadership. Our distinguished team of seasoned scientists has successfully executed more than 600 studies for Investigational New Drug (IND), New Drug Application (NDA), Biologic License Application (BLA), and Generics Application (ANDA) filings with the US FDA. We possess an astute understanding of the critical significance of budget and timeline, having navigated these challenges ourselves as a fast growing, small business. Speak to our scientists today to explore how our top-notch bioanalytical services can bolster your groundbreaking drug development initiatives.

                                                            What are your typical turnaround times for Bioanalytical Services?

                                                            Generally, we need just four-to-six weeks for most bioanalytical services such as method development and validation following the issuance of purchase order and securing of all assay supplies. Afterward, we need another five-to-ten days for submitting your audited bioanalytical lab report with complete details of method validation experiments and a few batches of sample analysis data. Please note that turnaround times for your method set-up and sample analysis may vary based on i) Specific Ligand Binding Assay and Materials (e.g., antigen/antibody pair availability, etc), ii) Mass Spectrometry Method and Materials (e.g., sample preparation, extended run time/duplicate injection, assay with multiple analytes / metabolites, Other Materials – required columns, well plates, and materials etc), and iii) Test article, Formulation, or Control Matrices – large quantities, controlled substances, specific vehicles, exotic species, uncommon matrices, etc

                                                            Do you follow the FDA and ICH guidelines for Bioanalytical Services?

                                                            Yes! NorthEast BioLab is registered with and has been successfully audited by the US Food and Drug Administration (FDA) multiple times for good laboratory practices. We also keep our registrations in good standing with the United States Drug Enforcement Administration (DEA) and the Connecticut State Department of Consumer Protection.

                                                            Our clients can rest assured that we are in full compliance with all relevant industry regulations, e.g., FDA validation guidance and ICH guidelines for method validation. By stringently following these regulations, Northeast BioAnalytical Laboratories seamlessly completes each study that we accept. Please contact us if you would like additional proof or documentation of our credentials and certifications.

                                                            How do you work with third-party providers – CROs, vivariums, other labs, and consultants?

                                                            As your trusted bioanalytical lab, NorthEast BioLab flexibly partners with a vast network of affiliates to deliver requested analytical testing, preclinical, and clinical CRO solutions. With us, you’ll not only get access to first-class, client-focused bioanalytical laboratory services but also recommendations for preferred life sciences consultants and in-vivo, pathology, and materials providers. Speak with our veteran team to get head-start on your study and beat competitors to market.

                                                            Contact A Scientist With Your Bioanalytical Study Details

                                                            We Will Respond Within 1 Business Day

                                                            Expertise

                                                            Expertise

                                                            • Mass Spectrometry (LC-MS)
                                                            • Meso Scale Discovery Assay
                                                            • ELISA Assay
                                                            • Flow Cytometry
                                                            • qPCR Analysis, ddPCR Assay
                                                            • Western Blot, In Cell Western

                                                            Services

                                                            Services

                                                            • Pharmacokinetics (PK) Study
                                                            • ADA Assay, Neutralizing Antibody Assay
                                                            • Multiplex Cytokine Assay
                                                            • Biomarker Assay
                                                            • Cell-Based Assay
                                                            • Bioanalytical Assay Validation

                                                            Solutions

                                                            Solutions

                                                            • Clinical CRO
                                                            • GLP Laboratory
                                                            • Preclinical CRO
                                                            • Method Development, Validation, And Transfer
                                                            • Analytical Testing

                                                            About Us

                                                            About Us

                                                            • Overview
                                                            • Leadership
                                                            • Facility and Equipment
                                                            • Quality and Compliance
                                                            • Therapeutic Areas
                                                            • Why Us?
                                                            • Values
                                                            • Process
                                                            • Partners
                                                            • Careers

                                                            Resources

                                                            Resources

                                                            • Learning Center
                                                            • Blog
                                                            • Case Study
                                                            • Video Brochures
                                                            • News and Events
                                                            • Testimonials
                                                            • Contact Us
                                                            NorthEast BioLab Logo Agile Bioanalytical Services CRO
                                                            sales@nebiolab.comFollow Up On Email
                                                            (203) 361 3780Follow Up On Phone

                                                            35 Worth Ave, Hamden, CT 06518

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