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                                                            • Home
                                                            • ADA Assay, Neutralizing Antibody Assay, Immunogenicity Assay Testing Services

                                                            Highly Sensitive, Specific ADA Assay, Cell-Based NAb Assay, And Immunogenicity Testing Services!

                                                            Contact A Scientist For ADA Assay Or Cell-Based nAb Assay

                                                            We Will Respond Within 1 Business Day

                                                            • Highly Sensitive And Drug Tolerant Meso Scale Discovery Or ELISA ADA Assay Development Using Acid Dissociation, SPEAD, ACE, BEAD, PANDA, Etc
                                                            • Multi-Tiered Screening, Confirmation, And Titration Cut Point Driven ADA Immunogenicity Testing Assay Validation For MAb, Peptide, ScFv, Protein, Etc
                                                            • Indirect Or Direct Cell-Based Neutralizing Antibody (nAb) Assay Development And Competitive Ligand Binding Neutralizing Antibody Assay
                                                            • FDA Audited Immunoassay Development For Risk Based Immunogenicity Testing Services Of Preclinical Or Clinical Trial Samples

                                                            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

                                                            Which Anti-Drug Antibody (ADA) Assays, Neutralizing Antibody (nAb) Assay, And Risk Based Immunogenicity Services Do We Offer?

                                                            Advanced Anti-Drug Antibody (ADA) Assays Development, Neutralizing Antibody (nAb) Assay Development, And ADA/nAb Assay Validation Services CRO For Your Immunogenicity Assessment!

                                                            ADA assay development, optimization, and transfer for biologics, cell, and gene therapy.

                                                            • Bridging Anti-Drug Antibody Assay Development On Meso Scale Discovery Or ELISA For MAb, Peptide, ScFv, or Protein, With In-House Tagging (Ruthenylation, Biotinylation) Of Critical Reagents
                                                            • Drug Tolerance Improvement Using Acid Dissociation, Solid-Phase Extraction With Acid Dissociation (SPEAD), Affinity Capture Elution (ACE), Biotin-Drug Extraction And Acid Dissociation (BEAD), Precipitation And Acid Dissociation (PandA), Etc

                                                            Fit-For-Purpose or GLP Anti-Drug Antibody Assay Validation

                                                            • High-Quality ADA Assay Validation Based on a Multi-Tiered Approach, i.e., Screening, Confirmation, And Titration Cut Point as Per FDA’s Guidance On Immunogenicity Testing of Therapeutic Protein Products
                                                            • ADA Method Validation Plan Approved in Advance For Sponsor Feedback On Crucial Decisions, Such as Diseased vs. Healthy population, # of selectivity and specificity testing lots for preclinical vs. clinical testing

                                                            Risk-Based Immunogenicity Assessment For Preclinical Or Clinical Samples

                                                            • Reliable, Multi-Tiered Sample Analysis with Initial Screening, Followed By Confirmation, And Titration Driven by Floating Assay Cut points
                                                            • Specifically, i) ADA screening assay to detect high and low-affinity anti-drug antibodies, ii) ADA Confirmatory assay to eliminate false positives from nonspecific binding, iii) ADA Titer assay to determine the magnitude of ADA response, and iv) ADA neutralizing antibody (NAb) assay to characterize the neutralizing activity

                                                            Development of cell-based and competitive ligand binding nAb assays for reliable results.

                                                            • Indirect or Direct Cell-Based Neutralizing Antibody Assay based on observed cellular response and your therapeutic’s mechanism of action as well as agonistic or antagonistic properties
                                                            • Reproducible Non Cell-Based, Competitive Ligand Binding Assay for soluble receptors or receptor-Fc fusion MAb and proteins with humoral targets to detect the Nab incidence and characterize the immune response as either neutralizing (NAb-positive) or non-neutralizing (NAb-negative)

                                                            Fit-for-purpose or GLP validation for neutralizing antibody assays in clinical studies.

                                                            • Robust nAb Assay Validation With NAb-specific assay tiers (i.e., screen, confirm, titer) for high-risk biologic products homologous to endogenous protein with non-redundant function, where NAbs may cross react with the endogenous counterpart and can have critical safety consequences
                                                            • nAb Method Validation Plan Approved in Advance For Sponsor Feedback On Crucial Decisions, Such as i) format selection; ii) cut point assessment; (iii) acceptance criteria; iv) sensitivity including positive control and negative control selection; v) selectivity/specificity; vi) drug tolerance; vii) target tolerance, etc

                                                            Tailored nAb assays to support cell and gene therapy (CAR-T) applications.

                                                            • AAV Neutralizing Antibody (NAb) Assay to assess transduction inhibition of AAV resulting from the presence of anti-AAV Neutralizing antibodies
                                                            • Custom Neutralizing antibody assay, including parallel NAb-specific assay tiers (i.e., screen, confirm, titer). testing flow where NAb is used for trial inclusion/exclusion purposes, or to support otherwise high-risk products

                                                            Our Veteran Scientists Have Deep And Diverse Expertise In ADA Assay Development And Cell-Based Neutralizing Antibody Assay Development for Immunogenicity Analysis!

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                                                            Human MAb ADA ELISA

                                                            Drug Tolerant, Acid Dissociation Based MSD Bridging Assay Development And Validation In Human Serum

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                                                            CAR-T ScFv ADA ELISA

                                                            In-house Reagent Tagging, MSD Bridging ADA Assay Development And Validation In Human Serum

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                                                            Humanized MAb ADA ELISA

                                                            Drug Tolerant, BEAD Based Anti-Drug Antibody (ADA) Assays Development And Validation In Human Serum

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                                                            Bispecific Ab ADA ELISA

                                                            MSD Bridging ADA Assay Development, Validation, And Immunogenicity Assesment In Human Serum

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                                                            EPO Cell Based NAb

                                                            Cell-Based Neutralizing Antibody Assay Development And Validation In Human Serum

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                                                            Renin Activity Based NAb

                                                            Activity-Based Neutralizing Antibody Assay Development And Validation In Human Serum

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                                                            Humanized FAb ADA ELISA

                                                            MSD ADA Assay Development, Validation, And Immunognecicity Assesment In NHP Serum

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                                                            Humanized FAb NAb CLBA

                                                            Bioassay Receptor Binding Based Competitive Neutralizing Antibody LBA In Human Serum

                                                            Contact A Scientist With Your ADA Assay and NAb Assay Details

                                                            We Will Respond Within 1 Business Day

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                                                            Outstanding ADA Assay Development And NAb Assay Development Lab Services

                                                            Contact A Scientist For ADA Assay Or Cell-Based nAb Assay

                                                            We Will Respond Within 1 Business Day

                                                            • We understand the critical nature of your ADA Analysis in clinical trials or NAb assay development projects. Do not allow your immunogenicity bioanalytical services provider bioanalysis lab to be the pitfall that delays the development of what could be the next world-leading therapeutic in the market.
                                                            • You are in the industry to make a difference. Having an extremely responsive and flexible immunoassay bioanalysis laboratory at your disposal for ada analysis in clinical trials and NAb assay would tremendously expedite your drug development process.
                                                            • You have a limited budget and tight timeline. That’s why sponsors trust our pre-established immunogenicity assay development expertise to quickly advance their assay optimization and data generation. We have gained our deep assay troubleshooting experience from hundreds of such bioanalysis projects.

                                                            20+

                                                            Years of Immunoassay Lab Services With Industry Leading Turnaround

                                                            450+

                                                            Custom Bioanalytical Methods Completed Within Budget

                                                            Expected Immunogenicity Services Turnaround

                                                            We sincerely collaborate with you to achieve our common bioanalysis goals and speed up your immunogenicity ADA analysis or nAb analysis Assay. Generally, we can develop and validate ADA or nAb assays in six-to-eight weeks. Then, we can deliver audited documentation of GLP/FFP qualification experiments in a few weeks. We have over 20 years of experience in designing, optimizing, and validating immunoassays for biotech companies. So, we use our core strengths- operational excellence, regulatory expertise, and scientific experience to ensure your ADA/nAb analysis is cost-effective and resource-efficient.

                                                            Requested Sponsor Input

                                                            Our team values clear communication between sponsors and our scientists, project managers, lab staff, etc. Could you please provide us additional introductory and background information about your therapeutic(s), target(s), preferred critical reagents, ADA and nAb assay supplies, previous immunogenicity analysis data from experimental run(s), immunogenicity ADA study protocols (with # of cohorts, ADA samples), and any crucial immunogenicity ADA Analysis or nAb analysis assay needs? All this information will help us accurately and efficiently define the scope of work for quotation and timeline estimation.

                                                            Reviews From Sponsors of Our Bioanalytical Assay Services

                                                            Sponsor
                                                            President & CSO, Biotech

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

                                                            Sponsor
                                                            Co-Founder, Biotech & University PI

                                                            NorthEast BioLab tremendously supported us in reproducing our critical lab discoveries for drug metabolism

                                                            Sponsor
                                                            VP, Bioanalytical Development

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

                                                            Sponsor
                                                            VP, Biomarker Development 

                                                            NorthEast BioLab is a responsive, collaborative, and reliable partner

                                                            Sponsor
                                                            VP, PK PD Analysis

                                                            NorthEast BioLab always exceeds expectations on bioanalytical assay development, validation, and sample analysis.

                                                            Sponsor
                                                            Sr. Associate Dir., Clinical Trials

                                                            We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.

                                                            Contact A Scientist For ADA Assay Or Cell-Based nAb Assay

                                                            We Will Respond Within 1 Business Day

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                                                            Premier ADA and nAb assay development services from immunogenicity experts to accelerate your program

                                                            Customized ADA and cell-based nAb assay development services

                                                            • Responsive ADA/nAb immunogenicity services with quick turnaround and sponsor feedback.
                                                            • Open communication with PhD scientists on assay preparation and troubleshooting.
                                                            • Focused program continuity and quality assurance for ADA, nAb, and immunogenicity analysis.

                                                            GLP/FFP ADA and cell-based nAb assay validation expertise

                                                            • Experienced scientists ensuring accurate ADA and nAb assay validation from the start.
                                                            • A thorough review of your ADA testing approach, data, and sponsor requirements.
                                                            • 30+ years of regulatory expertise and quality improvement in life sciences.
                                                            Bioanalytical Lab Services

                                                            Complete Guide On Anti-Drug Antibody (ADA) Assays Development, Immunogenicity Assessment

                                                            A comprehensive immunogenicity assessment of therapeutics through robust and reproducible anti-drug antibody (ADA) assay development is crucial to study the origin and prevalence of immune responses that can alter….

                                                            ADA Video
                                                            READ MORE

                                                            Our Risk-Based Approach To Comprehensive Immunogenicity Assessment For Your Therapeutics Includes Cell-Based NAb Assays

                                                            Positive
                                                            Screening Assay
                                                            Negative
                                                            Negative
                                                            Confirmatory Assay
                                                            (Titer Assay)
                                                            No Antibodies
                                                            Positive
                                                            Direct NAb Assay
                                                            Indirect NAb Assay
                                                            Altered Response
                                                            Confirmatory Assay
                                                            (NAbs Removed)
                                                            Normal Response
                                                            No NAbs
                                                            Altered Response
                                                            Specificity Assay
                                                            (No Drug Added)
                                                            Normal Response
                                                            No NAbs
                                                            Normal Response
                                                            NAbs Present
                                                            Altered Response (1)
                                                            Normal Response
                                                            NAbs Present
                                                            Altered Response (2)
                                                            General Immunoassay
                                                            NAb-Specific Assay

                                                            NOTE: (1) NAbs Absent; Not Responsible; (2) Drug Absent; NAbs Binding To Drug Not Responsible

                                                            Why Choose Us For Your Immunogenicity Assay Development Services?

                                                            FDA Audited Antibody Immunogenicity Assay Lab CRO Offering ADA Assay Development And Validation, Cell-Based Neutralizing Antibody Assay Development And Validation, Plus Immunogenicity Testing Services

                                                            Contact A Scientist For ADA Assay Or Cell-Based nAb Assay

                                                            We Will Respond Within 1 Business Day

                                                            • 20+ Years Designing, Optimizing, And Validating EMA And FDA-Compliant Multi-Tiered Immunogenicity Assays For Biotech
                                                            • Tailored Immunogenicity Testing Methods With Cut-Point Analysis And Drug Or Antigen Interference For Immunogenicity ADA And NAb Assay
                                                            • LBA And Cell-Based Neutralizing Antibody Assays For Patient, Product, Or Administration Related Immunogenicity Analysis
                                                            • Reliable And Dedicated Immunoassay Team To Perform TAb And NAb Immunogenicity Assessment For Safety And Efficacy
                                                            • 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
                                                            • United States Drug Enforcement Administration | NorthEast BioLab
                                                            • Department of Consumer Protection | NorthEast BioLab

                                                            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

                                                            Meso Scale Discovery Assay

                                                            ELISA Assay

                                                            Flow Cytometry

                                                            qPCR Analysis, ddPCR Assay

                                                            Related FAQs

                                                            Answers To Additional ADA/NAb Immunogenicity Services Questions Popular Among Our Potential Sponsors.

                                                            What Is an Immunogenicity Testing Assay?

                                                            Immunogenicity testing plays a crucial role in measuring the immune response elicited by large molecule drugs during biotherapeutics R&D. Given its defense mechanism, the human immune system marks large molecules as foreign invaders and mounts a subsequent reaction. Typically, this happens through the production of antibodies to remove or destroy the external elements. During the immune response, the large molecules can create even larger macromolecules that further change the immunogenicity profile of the underlying drug. In other words, the immune response triggered by the therapeutic compound or its delivery vehicle can impact the efficacy and safety of the drug. Thus, immunogenicity testing methods is an essential step in immunogenicity assay development.

                                                            Immunogenicity assays are complicated because of multiple interactions that occur between the drug, target, and sample matrices. Thus, careful selection of the assay format is critical for further optimization and validation. NorthEast Biolab has extensive experience in designing, validating, and optimizing antibody immunogenicity assays according to regulatory and safety guidelines by the FDA. Our scientists systematically develop your immunogenicity testing methods for high quality and reproducible antibody immunogenicity assays. Usually, we support clients in developing a screening assay to measure immunogenicity. This is followed by ADA titer assay and confirmation assays. We also help in developing custom antibody immunogenicity assays by checking the risk or safety profile of the antibody and the intended purpose of the drug.

                                                            What are the various Immunogenicity ADA Assays Offered by Us?

                                                            Immunogenicity ADA assays are critical in measuring an immune response against the therapeutic proteins. These tests also measure the various anti-drug antibodies (ADA) and soluble protein biomarkers. The findings from these measurements impact dose selection and the safety profile of the drug. The soluble protein biomarkers quantified during ADA assay can reveal target engagement, provide a mechanism of action, and predict the immune response related to the drug.

                                                            ADA Samples for immunogenicity ADA assay contain complex matrices that can create considerable interference and cause inaccuracies. Hence, scientists formulate strategies to reduce interference in ADA immunogenicity testing methods and accurately support the immunogenicity assay development of therapeutic antibodies and other drug candidates.

                                                            NorthEast Biolab has 15+ years of experience in designing, optimizing, and validating ADA assays for biotech and pharma companies. We implement GLP and GCP evaluation of a new biologics in preclinical and clinical stages, respectively. Our veteran scientists have worked on a variety of immunogenicity assay development to provide highly sensitive and selective methods.

                                                            Our immunogenicity testing services include the following procedures, at all stages of the immunogenicity assay development process:

                                                            • Purification, modification, and procurement of antibodies
                                                            • Immunogen and antigen preparation
                                                            • Cell line formation
                                                            • Development and optimization of immunoassays
                                                            • Reagent preparation
                                                            • Anti-drug antibody testing
                                                            • Titration and isotyping

                                                            What are Anti-drug antibodies (ADA)?

                                                            The body produces Anti-drug antibodies (ADA) as an immunogenic response against therapeutic proteins, enzymes, antibodies, peptides, and other biologic combination products. ADAs, somewhat identical to the proteins found in the human body, are complex macromolecules composed of hundreds of amino acids. The generated ADA antibodies could bind to various epitopes of the biologics, making them ineffective. Additionally, these antibodies can neutralize or break down the biologics or drug products into their components in many ways. The human body makes five different antibodies called immunoglobulins (Ig) to combat different antigens, namely IgA, IgG, IgM, IgE, and IGD. We test all relevant Ig isotypes in the initial ADA screening assay, depending on the route of administration and clinical evidence or risk of anaphylaxis. We also perform ELISA ADA assays. Generally, the FDA doesn’t mandate the determination of Ig isotype in screening assays. That said, assessment of antigen-specific Ig assays and evaluation of the generated Ig ADA subtype is sometimes deemed informative based on the drug therapy.

                                                            What is the importance of immunogenicity assay?

                                                            Immunogenicity is defined as any drug compound’s ability to evoke an immune response. Immunogenicity testing in clinical trials is necessary because sponsors seeking regulatory approval must ensure that their drug doesn’t elicit an adverse immune response upon administration. Typically, immunogenicity results from the detection of drug biomaterial as a foreign object by the body’s immune response. Depending upon the biomaterial, the T-helper cells usually form a cascade and migrate towards the drug. It is challenging to predict how these T- helper cells would respond to a specific therapy. This immunogenic response could be the reason for the limited binding between the biomaterial and the site of action or the rejection of biomaterial altogether. The immunogenicity prediction for immunogenicity testing in clinical trials could be based upon drug performance in preclinical testing. NorthEast BioLab performs antibody immunogenicity assays such as ADA and NAb Testing to evaluate antibodies produced against your biologics.

                                                            For comprehensive immunogenicity bioanalytical services, NorthEast BioLab offers specialized ADA and NAb Testing to assess immune responses to biologics during immunogenicity testing in clinical trials, ensuring regulatory compliance and drug safety.

                                                            What are the critical immunogenicity assays in drug development?

                                                            Immunogenicity assays can be involved, given the complexities and interferences associated with the various sample matrices, drug therapy, and targeted site of action. That said, the Anti-drug Antibody (ADA) assays (screening, confirmation, and titration) and Neutralizing Antibody (NAb) assay are the most common assays during the drug development process. The ADA and NAb assays are completed to identify and evaluate the antibody that binds with any therapeutic product. Our scientists obtain rigorous and actionable data for your drug development through highly sensitive and precise Anti-drug Antibody and Neutralizing Antibody assays.

                                                            What is ADA assay development and validation?

                                                            Anti-drug antibody (ADA) assays development and validation is an essential step in the clinical and preclinical testing of biologics for managing immune responses that affect drug therapy safety and efficacy. Our immunogenicity experts are well versed in the antibody immunogenicity assay development and validation of qualitative and semi-qualitative immunoassays using the FDA recommended multi-step approach to measure ADAs and NAbs. As the first step, our scientists screen patient samples to detect ADA immunogenicity. Next, the ADA samples are evaluated for cut point analysis, which is a test to eliminate false-positives and perform the confirmation assay for potential positives. As a confirmatory assay, we determine the ADA titer assay assessment and specificity of the binding. Afterward, all confirmed ADA positive samples are assayed for the presence of neutralizing antibodies by NAb assay.

                                                            What is the multi-tiered approach to Anti-drug Antibody (ADA) testing?

                                                            ADA assay development is a multi-step bioanalytical approach that includes several assay formats and method validation for suitable immunoassays. In the first tier, our scientists utilize a sensitive screening assay, aka binding antibody assay, to analyze biological samples for low and high-affinity ADA antibodies. In the second tier of our Anti-drug Antibody testing, we perform a cut point analysis to determine positive or negative ADA samples. Any samples that demonstrate potential binding get re-tested for specificity by competition with the therapeutic protein in a confirmatory assay. At this point, the FDA recommends that sponsors conduct risk-based characterization testing for any cross-reactivity, isotypes assessment, and epitope specificity. After ADA confirmatory assay, positive samples need to be tested further for neutralizing and titration assays.

                                                            What is the Neutralizing Antibody (NAb) assay?

                                                            Neutralizing Antibody (NAb) assays are a necessary component for immunogenicity testing in clinical trials when anti-drug antibodies are detected in patient samples. NAbs can neutralize the effects of biomaterials and are evoked in the body as an adverse immune response to therapeutic proteins. In these NAb assay, it is crucial to observe whether i) patients are producing anti-drug antibodies and ii) these antibodies are neutralizing the therapeutic drug effects. NorthEast BioLab immunogenicity professionals design and develop your customized and specific Neutralizing Antibody assay. We utilize MSD Quickplex 120 to increase NAb assay sensitivity and dynamic range, as well as limit matrix effects as compared to traditional ELISA.

                                                            How do you perform an immunogenicity test?

                                                            Immunogenicity test is crucial in ADA immunogenicity analysis in clinical trials from Phase I through Phase III. Enzyme-linked immunosorbent assays (ELISA) offer the traditional approach to quantitate ADA antibodies from administered drug therapy. First, we coat the polystyrene plate with a solution of capture antigen or antibody and wash the plate. Next, we add a blocking solution, incubate, and rewash. Afterward, we add biological samples from the drug therapy administration and rewash. At this time, the ADA antibodies can bind with the capture antigen or antibody. Finally, we add the detection substrate that emits a color if the ADA target is identified. Notably, the MSD immunogenicity assay has several advantages over conventional ELISA, including higher sensitivity, matrix tolerance, free drug tolerance, and lower sample volume requirement. It is essential to perform both ADA and NAb assays if patients are showing immunogenicity against your drug therapy. Our MSD Quickplex 120 platform delivers high-performance ADA immunogenicity assay for broad range multiplex detection using electrode plate binding and electrochemiluminescence quantitation.

                                                            For comprehensive immunogenicity bioanalytical services, including advanced MSD immunogenicity assays, contact us today.

                                                            What are the risk factors for immunogenicity testing?

                                                            Immunogenicity testing is crucial because the protein-based therapeutics, such as monoclonal antibodies and vaccines, are sometimes recognized as foreign particles by the body and induce an unwanted immunogenic response. Thus, immunogenicity assessment of biologics or therapeutic proteins is mandatory for regulatory approval. Often immune response involves B or T cell epitopes. For immunogenicity prediction, histocompatibility complex class II/ MHC is identified as an immunogenic molecule that shows T-epitopes as the receptors for cascade responses. These types of cells are responsible for producing antibodies and inactivating the administered protein-based drugs. Other risk factors for immunogenicity testing include dosage, administration route, delivery vehicle, and immune system activation to predict the immunogenicity of protein. Thus, measuring the capacity of producing antibodies is an essential aspect for the safety of immunogenicity testing in clinical trials and for the success of therapeutic drugs. Immune tolerance can also significantly affect the therapeutics product design in many cases. Rheumatoid Arthritis and Hemophilia A exemplify health conditions that have complicated treatments due to immunogenicity. Immunogenicity bioanalytical services are indispensable for evaluating the safety and efficacy of protein-based therapeutics, ensuring regulatory compliance and optimizing treatment outcomes.

                                                            How do immunogenicity assays support clinical and preclinical studies?

                                                            Immunogenicity assays during clinical and preclinical studies evaluate the tendency of biologics to produce an immune response in the form of ADAs and NAbs. Immunogenic response against biologics and therapeutic proteins is a common concern for scientists and clinicians focused on drug development. These responses could result in adverse clinical events due to the inactivation of drug therapy for patients. Several factors determine whether any biologic does or does not evoke an immune response, including drug structure, variants, immunogenic status, dosage, route of administration, and genetic profile of treated patients. The overall purpose of immunogenicity study, ADA assay specifically, is to determine whether ADA antibodies are generated and can cause adverse events or loss of efficacy. NorthEast BioLab experts develop and validate your antibody immunogenicity assays, including ADA and NAb assays, to analyze your novel compounds in clinical and preclinical studies.

                                                            For comprehensive immunogenicity bioanalytical services, including the development and validation of ADA and NAb assays, NorthEast BioLab offers expertise in assessing the immunogenic potential of your novel compounds throughout clinical and preclinical studies.

                                                            Speak To Our Scientist About Your Anti Drug Antibody (ADA) Assay Development, Immunogenicity Assessment, And FDA Guidance

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                                                            • Cell-Based Assay | NorthEast BioLab Cell-Based
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                                                            Contact A Scientist With Your Bioanalytical Study Details

                                                            We Will Respond Within 1 Business Day

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                                                            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

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

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