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                                              • Sr. Scientist - Pharmacokinetics (PK) Studies
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                                                            • ELISA Assay Validation, ELISA Immunoassay, And ELISA Testing Services Lab CRO

                                                            Pioneering ELISA Assay Validation, ELISA Testing Services Lab For PK/PD, ADA/nAb, Cytokine, Or Titration Assay!

                                                            • Reproducible Sandwich, Competitive, and Indirect ELISA Testing Services Lab For Quantitating Antibody, Cytokine, Protein, Peptide, Small Molecule, Etc
                                                            • Rapid ELISA Assay Development, GLP ELISA Assay Validation For Biologics, Vaccines, Biomarkers, Viral Titers, And Cell Based Assays
                                                            • FDA Audited Preclinical/Clinical ELISA Immunoassay Services (Absorbance, Meso Scale, Luminescence, Fluorescence, TR-FRET, AlphaLISA)
                                                            • Tailor-Made, High-Value ELISA Lab Services Using Proprietary/Commercial Antibodies And Research Use (RUO) Kits For 1,000+ Analytes

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                                                            Contact A Scientist For ELISA Assay Validation Lab Services

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                                                            Lab
                                                            + Years Of Bioanalysis
                                                            + Small/Large Molecule Studies
                                                            + Custom Bioanalytical Assays
                                                            + Investigational Drugs
                                                            + Biomarker & Cytokine Assays

                                                            Which ELISA Assay Validation And Enzyme-Linked Immunoassay (ELISA) Lab Testing Services Do We Offer?

                                                            Advanced Enzyme Assay Development, GLP ELISA Method Validation, ELISA Lab Services Lab To Accelerate Your PK/PD, ADA/nAb, Multiplex ELISA Cytokine Analysis, Or Titration Assays!

                                                            Pharmacokinetics (PK) ELISA Assay Development, Troubleshooting, Or ELISA Validation

                                                            • Sensitive, selective, and specific ELISA PK Assay for Antibodies, Proteins, Oligonucleotides, etc
                                                            • Ligand-binding (Direct, Indirect, Sandwich, Competitive) ELISA Method Or Hybrid ELISA Assay

                                                            Custom ADA Immunogenicity ELISA Lab Services With Neutralizing Antibody (nAb) Biological Assay Development

                                                            • Sensitive, Free Drug Tolerant, Three-Tiered ADA Assay (Bridging, Acid Dissociation, ACE, SPEAD, Etc) For Biologics (mAbs, Peptides, etc) And Cell Therapy (CAR, ScFv)
                                                            • Competitive LBA Or Cell Based ELISA Method For Neutralizing Antibodies Assay

                                                            Ultra-Sensitive Mesoscale Cytokine Analysis On MSD Multiplex Or Single-Plex ELISA Kits

                                                            • Meso Scale ELISA Assay CRO services to quantitate up to ten (10) cytokines, chemokines, growth factors, etc in a small volume sample
                                                            • S PLEX MSD ELISA Cytokine Assay to detect multiple biomarkers simultaneously (or as single analyte) at femtogram/mL concentrations

                                                            Preclinical (GLP) And Clinical (GCP) ELISA Assay Validation Services Lab

                                                            • Fit-for-purpose (FFP) Assay Validation in the Context-of-Use (COU) as per FDA Bioanalytical Method Validation (GLP, GCLP) Guidance
                                                            • Highly sensitive, validated ELISA Method with broad dynamic range given usual clinical sample collection and storage limitations

                                                            Pharmacodynamic (PD) Biomarker Evaluation ELISA Analysis Service

                                                            • PD Biomarker Immunoassay Service to confirm Mechanism of Action (MOA)
                                                            • Analytical, Cellular, or Functional ELISA Method For Target Identification and Validation

                                                            Cell-Based Assay And ELISA Testing Services For Potency, Neutralizing Antibodies, Or Mechanism Of Action (MOA)

                                                            • Direct or Indirect Cell Based Assay ELISA in presence/absence of added therapeutic, ligand, or another stimulus
                                                            • Functional Bioassay For Potency And Quantitative Cell Based Assays Reflecting MOA Using Luciferase Or MTT Systems

                                                            ELISA Lab Services For Viral Titer Quantification And Antibody Titer Determination

                                                            • Tailored ELISA Method For AAV Capsid Titration, Lentiviral Capsid Protein Quantification, etc. using proprietary or commercial assay supplies
                                                            • ELISA Analysis to determine the titer of specific antibody responses in wide variety of species and biological matrices

                                                            ELISA Analysis, Lab Testing, And Screening Services For Immunogenicity Assay (ADA, nAb), Pharmacokinetic (PK) Samples, And Cytokine Biomarkers

                                                            • GLP PK/ADA/nAb ELISA Lab Studies in rodents and large animals as well as clinical trial samples
                                                            • Pharmacokinetics or Biomarker evaluation in multiple matrices including plasma/serum, urine, CSF, cell lysates, and tissue homogenates

                                                            Our ELISA Assay Experts Have Deep & Diverse Experience With Enzyme-Linked Immunoassay Technology And Applications!

                                                            Let’s Connect Today About Your ELISA Needs And Our Lab Experience On Any Relevant Case Study Below

                                                            • Human MAb: PK ELISA Assay Development, GLP Validation, and EISA Testing Services in SD Rat, Minipig, and Human Plasma
                                                            • Humanized FAb: PK ELISA Assay Validation, GLP ELISA Immunoassay in NHP Plasma (nGLP Ocular Tissues)
                                                            • Human MAb: Drug Tolerant, Acid Dissociation ADA ELISA Monoclonal Antibody Assay Development And Validation (Healthy/Patient Serum)
                                                            • Humanized Fab: Bridging Anti Drug Antibody Assay Development, ELISA Validation, And Sample Analysis in NHP Serum Samples
                                                            • Oligonucleotide: MSD Hybrid ELISA PK Assay Development, GLP Validation, ELISA Analysis in Rabbit/Rat/Human Plasma and Human Urine
                                                            • H3K27me3/H3K4: AlphaLISA And ELISA Biomarker Development, Qualification, and Sample Analysis for in Monocytes Isolated From Human PBMC Samples
                                                            • Phospho-Histone H2AX: ELISA Biomarker Development, Qualification, and Sample Analysis in Human PBMC Samples
                                                            • Inflammatory Cytokines: V-PLEX Meso Scale ELISA Assay Validation in Mouse Plasma, Urine, CSF, And Tissue Lysates
                                                            • Cytokines And Chemokines: S-PLEX MSD ELISA Multiplex Method Development, And Sample Analysis in Human Plasma And Cell Lysates
                                                            • Cytokine Inhibitor Protein: PK ELISA Based Assay Development, GLP Validation, And ELISA Testing Services in Human Plasma

                                                            Ready To Tackle Your ELISA Monoclonal Antibody Assay With Our Veteran Team?

                                                            Speak To Our Scientists

                                                            Over 20+ Years, Our Team Has Completed 600+ Bioanalytical Studies To The Benefit Of Our Mission Driven Sponsors!

                                                            20+

                                                            Years of ELISA Lab Services With Industry Leading Turnaround

                                                            300+

                                                            Custom Bioanalytical Methods Completed Within Budget

                                                            Comprehensive Suite of PK/PD, ADA/nAb, And ELISA Biomarker Assay Services To Exceed Your Expectations

                                                            • Your ELISA Based Assays matter to us. Don’t allow any ELISA Services Laboratory CRO to gloss over hidden pitfalls that can delay the development of your next therapeutic.
                                                            • You are in the industry to improve the standard of care. Having an extremely responsive and flexible ELISA Immunoassay Services lab at your disposition will tremendously expedite your drug development.
                                                            • Your budget needs to be stretched. Our ELISA Method Development expertise will ensure that your get farther along the regulatory submission process without spending more.

                                                            Do not wait any longer.

                                                            Request a Quote Today
                                                            Lab

                                                            Expected Services Turnaround

                                                            We are thrilled to collaborate with your team and achieve our shared goals for your ELISA Assay Development and Immunoassay Validation. We can develop and validate de novo ELISA PK/ADA or ELISA biomarker assays in six to eight weeks. Then, we can deliver your audited report with detailed documentation of ELISA Immmoassay Validation experiments in a few weeks. We constantly stretch your budget by combining our scientific experience, regulatory expertise, and operational excellence.

                                                            Requested Sponsor Input

                                                            We are eager to work with you on your ELISA Immunoassay project. We believe close communication is vital to success, and want to understand your needs and expectations in advance as much as possible. To help us prepare a detailed quote and timeline, please share additional information about your analyte(s), critical reagents and supplies, current and previous Enzyme Linked Immunoassay, study protocols, and sample sizes. Thank you for choosing us as your bioanalytical partner in cutting-edge science!

                                                            Reviews From Sponsors of Our ELISA Based Immunoassay Services

                                                            Connect With Us for a Reference Call with Them!

                                                            Head, Bioanalytical Development

                                                            NorthEast BioLab truly goes that extra mile, and we hope to continue enjoying seminal interactions with them.

                                                            Sr. Dir., Bioanalytical Development & QC

                                                            NorthEast BioLab presents a science-based, hands-on, no-frills approach on the latest bioanalytical platforms.

                                                            VP, Bioanalytical Development

                                                            NorthEast BioLab is by far the most responsive and thorough bioanalysis lab services CRO.

                                                            VP, Development Operations

                                                            As a small company, our vendors are key members of our project teams. The scientists at NorthEast BioLab are technical experts, who produce high-quality data, on-time, and on-budget.

                                                            VP, Biomarker Development 

                                                            We partnered on several programs and found NorthEast BioLab responsive, collaborative, and reliable.

                                                            Executive Director, Pharmacokinetics

                                                            We trust NorthEast BioLab to design and execute the most streamlined and impactful bioanalytical projects.

                                                            President & CSO, Biotech

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

                                                            Sr. Associate Dir., Clinical Trials

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

                                                            Co-Founder, Biotech & University PI

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

                                                            VP, PK PD Analysis

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

                                                            SVP Quality & Compliance, Biotech

                                                            We are thrilled to complete our bioanalytical studies with their top quality and incredibly responsive team.

                                                            Director, PK

                                                            We worked closely to implement the most efficient and cost-effective bioanalytical assay for our PK Studies.

                                                            VP, Head of Clinical Operations

                                                            Our projects with NorthEast BioLab include successful method development, validation, stability studies during Clinical Phase I – IV studies.

                                                            Executive Director, Drug Research

                                                            NorthEast BioLab provides critical insight, and are compliant with regulatory standards and industry best practices. We highly recommend them and look forward to working together again.

                                                            Dir., Bioequivalence Testing

                                                            Our latest successful study was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis.

                                                            Head, PK

                                                            This study, same as all other bioanalytical studies with NorthEast BioLab, was completed with top quality and reporting standard with incredible responsiveness.

                                                            Get Started Immediately On Your Crucial ELISA Service.

                                                            Speak To Our Scientists

                                                            Efficiently Accelerate Enzyme Linked Immunoassay For Your PK, Immunogenicity, and Multiplex ELISA Cytokine Analysis

                                                              GLP ELISA Assay Validation Expertise

                                                              • In-house ELISA Quantification and reagent tagging (biotinylation, ruthenylation, etc) experience and deep bench of veteran scientists to get it right in first go
                                                              • Upfront review of your ligand binding (LBA) ELISA method(s), current data, regulatory/sponsor requirements, assay supplies, etc.
                                                              • Regulatory awareness – 30+ years relationships within life sciences, providing immunoassay services

                                                              Tailored ELISA Based Assay Services Lab

                                                              • Responsive ELISA Analysis Services CRO focused on Rapid Turnaround, Scope Flexibility, Effort Transparency, and Sponsor Feedback
                                                              • Open Communication between Senior Scientists & Sponsors on all potential ELISA Assay troubleshooting approaches
                                                              • Program Continuity and Quality Assurance with 100% focus on your ELISA Quantification and Sample Analysis

                                                            Biomarker Assay List

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

                                                            Explore Our Biomarker List

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

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                                                            Rely On Our Results Driven Mindset For Your ELISA Assay Validation.

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                                                            Why Choose Us For Your ELISA Immonoassay Services?

                                                            FDA Audited ELISA Assay Validation, Immunossay Development, Or GLP Sample Analysis Services!

                                                            Logo Agile Bioanalytical Services CRO
                                                            • ELISA Method Development And ELISA Validation As Per FDA Guidance On Ligand Binding Assay (LBA) And Cell Based Assay (inc., Luminescence, Fluorometric)
                                                            • Research Mode Or GLP ELISA Lab Services For PK/Cytokine (Absorbance, Colorimetric), Or Immunogenicity Assay (Screening, Confirmation, Titration)
                                                            • Preclinical/Clinical ELISA Analysis Services For PD Biomarkers, Potency, Functional, And Mechanism-Of-Action Bioassays
                                                            • Tailor-Made, High-Value ELISA Services Lab For Viral And Antibody Titers In Various Biological Matrices

                                                            Regulated And Inspected By:

                                                            Contact A Scientist With Your ELISA Based Assay Details

                                                            We Will Respond Within 1 Business Day

                                                            Support Your Drug Innovation With Entire Suite OF BioAnalytical Services In Safe Hands Of Our Veteran Scientists

                                                            We judiciously invest in our people, solutions and infrastructure, and regularly review our business processes and practices to exceed sponsor expectations

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                                                            Questions On Our PK/PD, ADA/NAb, Or Titration ELISA Testing Services?

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                                                            Related FAQs

                                                            Answers to additional ELISA Lab Services questions popular among our potential clients.

                                                            What is Enzyme Linked Immunosorbent Assay (ELISA) Method?

                                                            ELISA Method: Accurate and Flexible Analysis in 96 well plates

                                                            Enzyme Linked Immunosorbent Assay (ELISA) method is a widely utilized immunoassay for quantitating and detecting proteins, hormones, peptides, cytokines, antibodies, and other drugs along with their metabolites. ELISA methods are effective in quantitatively detecting any molecule, or antigen, that can be ascertained by an antibody. For example, ELISA methods are used in pregnancy testing, infectious disease identification, and detection of cytokines, and soluble receptor proteins, etc. Due to the precision, sensitivity, assay speed, and ease of quantitation, ELISA method development is a common choice for several diagnostic and research applications.

                                                            While there are various formats of ELISA method, the most common is a sandwich ELISA method. In this format, the analyte whose concentration is to be measured is sandwiched in-between two antibodies that bind to a different region (epitopes) on the antigen. These antibodies are referred to as detection antibody and capture antibody. In this assay, the capture antibody is coated to a microtiter plate in a 96-well format. The antigen binds to the capture antibody, and a detection antibody is used to measure the analyte. The antibody is conjugated to an enzyme, typically horseradish peroxidase (HRP), and detected via catalysis of a substrate which yields a colored product. Spectrophotometry is used to monitor the colored product, and a standard curve is utilized for calculating the antigen concentration in the sample. When the antigen is small, or two antibodies that can simultaneously bind to the antigen are unavailable, then another variation of ELISA, termed competitive ELISA method is utilized using a single epitope.

                                                            It is notable that the ELISA method typically uses 96 microwell plates for parallel analysis of many samples, standards, and controls in a single experiment. The surface of these plates is treated with special absorbents such that the antigen or antibody can adhere properly. ELISA method offers increased sensitivity and specificity compared to other standard antibody-based assays. In ELISA method, the interactions with analyte or antibody occur through serial binding that is done to some solid surface such as polystyrene in the 96 microwell plates discussed above.

                                                            What is ELISA Method Development?

                                                            Step-by-step ELISA Method Development

                                                            Enzyme Linked Immunosorbent Assay or ELISA Method development is a complex task involving multiple sequential steps for the measurement of analyte concentration in a sample.

                                                            Plate Coating

                                                            Whenever an ELISA method is developed for any analyte, a surface attachment strategy is established first. Once the analyte is affixed to the surface of the plate, it is immobilized and helps with the sequential addition of other reagents and washing cycles in the next steps, without mixing. ELISA method is thus a solid-phase assay.

                                                            The process of immobilizing an antibody or antigen to the plate is essential, as the method of immobilization utilized is what determines the efficacy of the ELISA method. Many times, the immobilization may cause a conformational change in the analyte or antibody, preventing the detection antibody from binding. Thus, it is critical to immobilize the antibody or antigen while preserving its conformational structure.

                                                            Antibody and Antigen Pairs

                                                            The specificity and sensitivity of the assay are determined using a range of concentrations of antibody and/or antigen. The affinity of the detection antibody and sensitivity of the detection reagents corresponding to a specific antigen are principally responsible for defining the performance of an optimized ELISA method. Selection of the best capture and detection antibody is critical for effective assay development.

                                                            Detection

                                                            The antibodies which are labeled with an enzyme (detection antibodies) contribute to the signal output of this assay. Different types of enzymes can be utilized, such as alkaline phosphatase, horseradish peroxidase, etc., each of which produces a color upon reacting with their substrates. These colored products are detected with spectrophotometry, where the signal intensity is proportional to the amount of antigen in the microwell. Afterward, a standard curve along with positive and negative controls is used to quantify the amount of analyte within a given sample.

                                                            Which ELISA Method Development do we Offer?

                                                            Extensive ELISA Method Development by NorthEast BioLab

                                                            NorthEast BioLab offers various client-centric ELISA method development services.

                                                            Bioanalytical Assay Development and Validation

                                                            Proper ELISA method development and validation are critical for the accurate quantification of an analyte. NorthEast BioLab helps you select the right ELISA method format and develop a robust protocol for analysis. Our specialists optimize the assay by titrating various components to ensure accurate results.

                                                            Pharmacokinetics (PK) Studies

                                                            Our pharmacokinetic studies for quantitation of drug-responsive levels of a specific serum protein using ELISA method development allow accurate and reliable pharmacokinetic data to help regulate dosage regimens.

                                                            Toxicokinetic (TK) Studies

                                                            As in pharmacokinetic studies, an ELISA method can be used in toxicokinetic studies to quantitate a drug or compound when administered at high dosage. TK studies allow estimation of the level of toxicity that can be produced by these drug compounds.

                                                            Biomarker Testing

                                                            ELISA method is hugely popular as a fundamental, cost-effective technique that offers high precision and broad dynamic range in addition to specificity, selectivity, and reliability for biomarker testing and quantitation.

                                                            Immunogenicity Testing Assay

                                                            An ELISA method can be used for immunogenicity testing. These studies are carried out to assess how drug exposure induces an immune response in the body of humans or other animals. It further evaluates how anti-drug antibodies (ADA) can affect immunogenicity.

                                                            Cell-Based Assay

                                                            Our scientists help clients with the successful execution of cell-based assays to assess the toxicity of the compounds and ensure reliable drug manufacturing. For example, we perform cytotoxicity testing and mechanism of action (MOA) assay to understand the biochemical reactions triggered by drug compounds.

                                                            Why Choose us for your ELISA Assay Validation?

                                                            Frictionless ELISA Method from scratch or validated Research Use Only (RUO) kits

                                                            At NorthEast BioLab, we ensure robust ELISA methods to quantify large molecule analytes such as biologics, proteins, and antibodies in your samples. As often as it takes, our veteran scientists with 30+ years experience discuss and study your ELISA method development and validation in depth. Our team continues without yielding until we have customized these assays per your requirement and satisfaction.

                                                            We encourage intensive collaboration between the client and our scientists for complete transparency throughout your study with us. NorthEast BioLab offers quick turnaround times, scalability, and flexibility, given our extensive experience with ELISA method development and a thorough understanding of the science behind it. We enable our clients to expedite drug approval through efficient assay development, validation, and optimization while maintaining 100% regulatory compliance.

                                                            ELISA Method, based on colorimetric or chemiluminescent reaction, is the best-in-class ligand binding assay (LBA) predominantly used for large molecule bioanalytical method development and sample analysis. Scientists and regulatory agencies widely trust the direct, indirect, sandwich, and competitive variants of ELISA Development and Method Validation for diverse PK, BA/BE, TK, Immunogenicity (ADA), and Biomarker testing. Our veteran team undertakes Enzyme Linked Immunosorbent Assay development from scratch using available antibodies, diluents, buffers, substrates, reagents, control matrices, as well as research use only (RUO) kits. NorthEast BioLab delivers research mode, and fully GLP validated ELISA Method and Assay Development at an unmatched turnaround and value to sponsors.

                                                            What is Enzyme Linked Immunosorbent Assay (ELISA) Method Development?

                                                            ELISA Method is an abbreviation for enzyme-linked immunosorbent assay, also called enzyme immunoassays (EIA). The fundamental principle used in ELISA method development is the use of antibodies to detect and quantify proteins, peptides, hormones, or other small molecules in preclinical or clinical samples. In an ELISA method development, antigens are immobilized on solid support either directly or via the use of a capture antibody immobilized on the surface. Subsequently, we add a primary detection antibody. If the detection antibody binds to the analyte of interest, the complex can be directly detected and quantified by the chromogenic tag or a secondary enzyme-conjugated antibody. In our GLP ELISA lab, we typically perform method development, validation, and sample analysis in multi-well plates (96- or 384-wells) for capture antigen binding. This characteristic makes the ELISA assay easy to perform on multiple samples simultaneously with excellent selectivity.

                                                            What are the various types of ELISA immunoassays?

                                                            ELISA immunoassays include a direct, indirect, sandwich, and competitive variants. In the direct ELISA method, an antigen is immobilized to the surface of a multi-well plate and detected with an antigen-specific antibody directly conjugated to HRP or another detection tag.

                                                            For an indirect ELISA assay, as with the direct ELISA method, an antigen is immobilized to the surface of the multi-well plate, but we need a two-step process for detection. The primary antibody binds to the antigen of interest, and then a secondary antibody labeled with a detection reagent is used for quantification. The sandwich ELISA method, the most widely used format, requires an antibody pair where each antibody is specific to a different epitope of the antigen. The first antibody, often called the capture antibody, is coated on the 96 well plate and binds to the analyte of interest. Once the unbound materials in the sample matrix get washed away, the second antibody conjugated with a detection tag quantitates the analyte. Competitive ELISA methods, often referred to as an inhibition ELISA assay or competitive immunoassays, measure the concentration of an antigen by detecting signal interference. We can adapt direct, indirect, or sandwich ELISA to the competitive format. Here, the antigen in the sample competes with a reference antigen pre-coated on a multi-well plate or added in the same plate wells. Consequently, lower concentrations of analyte produce a higher level of the signal. Some competitive ELISA assay, however, utilize a slightly different approach. These kits substitute a labeled antigen for the labeled antibody, but the principle of the assay remains the same.

                                                            Why is Sandwich ELISA method more sensitive?

                                                            In the Sandwich ELISA method, the specificity and selectivity offered by matched antibody pairs provide improved sensitivity and broad dynamic range. These ELISA assays require two antibodies, attaching with different epitopes on the same antigen, making them suitable for accurately isolating and quantitating antigens of interest within complex biological matrices such as plasma, serum, CSF, tissue lysates, etc. Furthermore, sandwich ELISA method development and validation are highly adaptable. We can optimize various assay conditions for the antibody pairs (e.g., type of assay plates, coating/washing/dilution buffer, coating-detection concentration, calibration standard/quality control/sample preparation, incubation times, etc.) to meet/exceed our immunoassay validation and sample analysis acceptance criteria. One of the most significant challenges faced by sponsor or ELISA Lab working on sandwich ELISA method is narrowing down a proprietary/commercially available antibody pair that works well together for desired assay parameters.

                                                            What is the difference between Direct ELISA vs. Indirect ELISA method?

                                                            In our GLP ELISA Lab, we perform both direct and indirect ELISA method development that differ in their means of detection. In the direct ELISA assay, an antigen is immobilized to the surface of a multi-well plate and detected with an antigen-specific antibody directly conjugated to HRP or other detection molecules. For an indirect ELISA assay, as with the direct ELISA method, the antigen is immobilized to the surface of the multi-well plate, but we need a two-step process for detection. The primary antibody binds to the analyte of interest and the secondary antibody labeled with the detection agent is used for quantitation. Direct ELISA methods are simple to set up and have no cross-reactivity from a secondary antibody but may have poor sensitivity due to high background as all proteins in the sample bind the well surface and there is no signal amplification to read the antigen. Indirect ELISA methods offer signal amplification to improve sensitivity but are more challenging to set up and perform and may have cross-reactivity from the secondary antibody.

                                                            What are the advantages of i) Direct ELISA, ii) Indirect ELISA, iii) Sandwich ELISA, and iv) Competitive ELISA?

                                                            The principle of ELISA involves antigen detection via binding to specific antibodies that we can apply in various formats. Direct ELISA method offers the advantages of easy experimental setup and execution, saving on time and reagent costs, and minimize concerns around cross-reactivity since there is no secondary antibody. Disadvantages of the direct ELISA method are the potential for high background due to all proteins in the sample binding the plate. Also, the primary antibody must be conjugated, and there is no signal amplification for analyte detection.

                                                            Indirect ELISA methods allow for signal amplification since multiple secondary antibodies can bind to the primary antibody. Indirect methods are also adaptable, allowing us to use the same secondary antibody for several primary antibodies. Disadvantages of an indirect ELISA method are potential cross-reactivity to the secondary antibody and higher time and cost needs relative to the direct ELISA method.

                                                            Sandwich ELISA methods offer excellent specificity as they employ two distinct antibodies for capture and detection. These ELISA, however, can be difficult to develop since discovering two antibodies that recognize two different epitopes on the same target and work well together can at times be difficult.

                                                            We can modify any ELISA method to a competitive format with a reference antigen and appropriate detection. Our team often employs Competitive ELISA to detect and quantitate low molecular weight antigens, such as small molecule drug compounds (e.g., Gentamicin).

                                                            What are the critical applications of ELISA Method?

                                                            ELISA labs perform sensitive and selective quantitation of various antigens during drug discovery and development. We rely on ELISA method development to evaluate pharmacokinetics (PK) or anti-drug antibody (ADA) for novel biological treatments and determine biomarkers predictive of preclinical or clinical disease, therapeutic treatment, or toxicity adverse events. In summary, our ELISA labs and assay kit vendor ecosystem can be immensely advantageous to your bioanalytical method development and validation. For many of your drug R&D assays, we can optimize commercial ELISA kits for performance, selectivity, sensitivity, and are adaptability to multiple biological sample matrices.

                                                            How do we perform ELISA method validation?

                                                            Enzyme-linked immunosorbent assay (ELISA) method validation should be fit for purpose and follow the FDA Bioanalytical Method Validation Guidance for Industry (May, 2018), specifically related to ligand binding assays (LBAs). Generally, ELISA method validation includes –

                                                            • All applicable experiments for Stock Solutions, Reference Standards, Quality Controls, Calibration Curve, Minimum Required Dilution, Spike Recovery, etc
                                                            • Six independent validation runs over multiple days for estimating Intraday and Intraday Accuracy and Precision
                                                            • Applicable experiments for Method Selectivity, Specificity, Matrix Effect, Matrix Suppression, etc.
                                                            • Process Stability experiments for Short-term Bench-Top, Freeze-Thaw, and Long-Term Cycles

                                                            How is ELISA method influenced by antibodies, blocking, diluents, washing, etc.?

                                                            ELISA Labs perform method development and validation for your analyte of interest as per assay requirements such as calibration range and limitations such as antibody pair affinity, minimum required dilution, observed background, etc. In sandwich ELISA methods, the antibodies selected for capture and detection must bind to two distinct epitopes of the antigen and work well to achieve the quantitative assay goals. Also, we must choose appropriate plate binding surfaces, assay blockers, and buffers for diluents and washing to suit the sample matrix and yield selective and sensitive quantitation. Furthermore, we need to carefully optimize antibody and sample concentration and incubation times for ELISA method development and validation. Among other factors, our scientists pay close attention to signal-to-noise (SNR) ratio, false-positive due to endogenous compounds, interference from endogenous or exogenous compounds, substrate selection, etc., for enhancing your ELISA method’s sensitivity, selectivity, specificity, and dynamic range.

                                                            How is ELISA Quantification affected by plate readers, pipetting, and equipment handling by lab personnel?

                                                            ELISA quantitation, like any other highly sensitive bioanalytical quantitation, should be handled with care and precision. To begin with, we must review proper calibration and verification of instrumentation, pipettes, and other equipment before use. Next, we must intensively train all ELISA lab personnel in protocol reproducibility, pipetting techniques, and pipette tip handling to perform ELISA Method Development and Validation. Generally, ELISA analysis plate readouts and incubation steps are highly time-dependent. Thus, we must emphasize that plates must be analyzed quickly following the addition of substrate for any pre-reads or final reads after stopping the reaction. We can automate sample analysis for ELISA assay with liquid handlers, plate washers, and other robotics adaptable to 96- or 384-well plates.

                                                            What are the significant limitations of an ELISA method?

                                                            ELISA methods and enzyme immunoassays are valuable tools for analyzing large molecule antigens, proteins, and antibodies but are not suitable for all small molecules and alternate biomolecules. For proper execution, ELISA assays must include reasonable incubation times, appropriate binding of antibodies to the intended epitopes for capture and detection, compatible buffers, and a suitable level of plate washing. Furthermore, ELISA methods do not generally include an internal standard (IS) as in chromatographic assays. That said, we may use a visible dye in the plate reader’s detection range to track dilutions throughout the assay as a surrogate ELISA IS to verify that your ELISA Lab properly executes the assay steps and dilutions.

                                                            How long does an ELISA Testing Services take?

                                                            Generally, our ELISA lab can perform sample analysis from 2-to-4 96-well plates within a typical workday if we have ELISA method development and immunoassay validation completed already. That said, sample preparation can vary per the complexity of the biological matrix and ELISA analysis itself (e.g., tissues or whole cells vs. serum). Similarly, sample incubation times can vary, typically overnight or less. Our scientists closely monitor and control the incubation and readout times during ELISA Method Development and sample analysis for consistency in your ELISA immunoassay results. Since the ELISA assay readouts are enzyme-dependent, lab personnel should read plates in the optimal reaction time window as the signal can decay markedly over time.

                                                            How does the ELISA Assay Development for anti-drug antibodies work?

                                                            Our GLP ELISA lab regularly performs immunogenicity studies that look for the potential immune response to therapeutic agents as needed for clinical drug studies. A bridging enzyme linked immunoassay is one of the most common methods to test for the presence and quantification of these anti-drug antibodies (ADA). In this sandwich ELISA assay development, a biotinylated drug compound gets attached to the streptavidin coated ELISA plate, and another labeled drug compound gets utilized as a detection agent. Ultimately, the anti-drug antibody of interest bridges these drug compounds together. Among other antibodies, this ELISA method gets frequently used for IgG and IgM ADA detection.

                                                            Can ELISA method be used for quantitative purposes?

                                                            ELISA methods and other types of enzyme immunoassays are typically used to quantitate large molecules in biological matrices with excellent sensitivity and specificity. It can be quite challenging to develop an ELISA method for a novel biologic molecule in-house. Thus, you would be in the superb company of pioneering biotech to rely on our ELISA lab to characterize your drug pharmacokinetics or its correlation to pharmacodynamic responses related to efficacy or toxicity. Generally, proper ELISA lab method development offers versatility and utility for biomarker determinations in relation to disease states and disease treatment and modulation. As with any other quantitative bioanalytical method, ELISA assay should be fully validated or at least partially qualified before use as appropriate to your study objectives.

                                                            How do you use Research Use Only (RUO) ELISA quantification Kits?

                                                            Research use only (RUO) label indicates in vitro diagnostic (IVD) products that can be used in the laboratory research phase of development. RUO ELISA kits are helpful for early drug discovery or preliminary diagnostic testing analyses but are not yet fully validated for compliance under GLP or clinical regulations. Commercially available RUO kits for ELISA lab protocols are typically qualified to some degree to ensure specificity, accuracy, and precision. Still, we need to fully validate these kits for the stability of test articles and critical reagents, cross-reactivity, or matrix interference. RUO ELISA Quantification procedures can be validated if the need arises, typically for novel biologic therapeutics reaching the preclinical toxicology phase or for novel clinical biomarkers of disease or therapy.

                                                            How is Enzyme Linked Fluorescent Assay (ELFA) different from Enzyme Linked Immunosorbent Assay (ELISA)?

                                                            Enzyme linked fluorescent assay (ELFA) is a similar enzyme immunoassay that uses the same principles as the ELISA assay but differs in the sample detection method. We use a fluorogenic substrate for detection in the ELFA assay instead of the chromogenic substrates used in ELISA assays. In general, ELFA is more sensitive than ELISA, making it helpful in detecting antigen biomarkers in earlier time windows relative to exposure for diagnostic disease testing.

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