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                                                      • Meso Scale Discovery (MSD) Assay ELISA Services

                                                      Premier Meso Scale Discovery Assay Service For PK, ADA, And MSD Cytokine Multiplex Bioanalysis!

                                                      • Rapid Meso Scale Discovery PK, ADA Assay Development For Preclinical/Clinical Studies
                                                      • Highly Sensitive MSD Cytokine Multiplex Assay with Broad Dynamic Ranges
                                                      • Fit-For-Purpose Or GLP MSD ELISA Assay Validation At FDA Audited Facility
                                                      • Competitively Priced, MSD Assay Lab Services CRO With 500+ Biomarkers

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                                                      Which Meso Scale Discovery (MSD) Assay Services Do We Offer?

                                                      Advanced MSD Assay Development, Optimization, and GLP Validation Services CRO To Accelerate Your Pharmacokinetic, Anti-Drug Antibody, Or Meso Scale Discovery Multiplex Cytokine Analysis!

                                                      PK/ADA MSD ELISA Assay Development, Optimization, or Method Transfer

                                                      • ELISA Conversion or First Time Design for sensitive, selective, and specific PK/ADA Assay
                                                      • Ligand-binding (Direct, Indirect, Sandwich, Competitive) Meso Scale Discovery ELISA Or Hybrid Assay for Biologics, Proteins, Oligonucleotides, etc

                                                      Meso Scale Discovery Assay Validation Services And GLP Sample Analysis

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

                                                      Meso Scale Immunogenicity (ADA, nAb) Assay, Pharmacokinetic (PK) Sample Testing And Screening

                                                      • GLP PK/ADA/nAb studies in rodents and large animals as well as analysis of samples in clinical trials
                                                      • Pharmacokinetics or Immunogenicity evaluation in multiple matrices including plasma/serum, urine, CSF, stool, cell lysates, and tissue homogenates

                                                      Ultra-Sensitive MSD Cytokine Multiplex Analysis using V-PLEX, U-PLEX, S-PLEX, R-PLEX panels

                                                      • 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 Cytokine Assay to detect multiple biomarkers simultaneously (or as single analyte) at femtogram/mL concentrations

                                                      Miscellaneous Preclinical and Clinical Custom MSD Assay Lab Support Services

                                                      • Tailored Meso Scale Discovery (MSD) cell based assay and research services using
                                                        proprietary or commercial assay supplies
                                                      • ELISA Conversion for sensitive, selective, and specific Meso Scale Discovery Assay in wide variety of species and biological matrices

                                                      Stability Testing Meso Scale Discovery Assay Lab Services

                                                      • Qualify your biologics’ PK or Cytokine Sample analysis following long term storage
                                                      • PK, ADA, or Cytokine Assay set-up and test run(s) for stock solutions, calibration curve, and quality controls

                                                      Meso Scale Discovery ELISA Assay Services: Trust Our Deep and Diverse Expertise

                                                      Let’s Connect Today to Discuss Your Project And Our Experience With Any Relevant Case Study Below

                                                      • Human MAb: Higher Sensitivity Mesoscale PK ELISA Assay Development, GLP Validation, And Sample Analysis in Human Plasma
                                                      • Human MAb: Drug Tolerant, Acid Dissociation based ADA Assay Development And GLP Validation in Human Serum (Healthy And Patient Population)
                                                      • Humanized Fab: Bridging Anti Drug Antibody Assay Development, GLP Validation, And Sample Analysis in NHP Serum Samples
                                                      • Oligonucleotide: Hybrid MSD ELISA PK Assay Development, GLP Validation, And Sample Analysis in Rat, Rabbit, And Human Plasma Plus Urine
                                                      • Inflammatory Cytokines: V-PLEX MSD ELISA Assay Development And 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
                                                      • Custom Cytokine Profiling Panel: S-PLEX Mesoscale ELISA Multiplex Method Development And Sample Analysis in Human Plasma
                                                      • Cytokine Inhibitor Protein: PK ELISA Assay Development, GLP Validation, And Sample Analysis in Human Plasma

                                                      Ready To Take The First Step, Today?

                                                      Explore Our Meso Scale Discovery (MSD) Assay ELISA Services Lab CRO!
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                                                      600+ Successful Bioanalytical Study Performed With 100% Client Satisfaction!

                                                      20+

                                                      Years of Bioanalysis Services in Industry Leading Time

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                                                      Custom Bioanalytical Methods Completed Within Budget

                                                      Comprehensive Suite of PK, ADA, and Biomarker Assay Services To Exceed Your Expectations

                                                      • Your Meso Scale Discovery PK, ADA, And Cytokine Assays matter to us. Don’t allow any bioanalytical laboratory CRO to gloss over hidden pitfalls delaying the development of your next therapeutic.
                                                      • You are in the industry to make a difference. Having an extremely responsive and flexible MSD Assay Services lab at your disposition will tremendously expedite your drug development.
                                                      • Your budget is limited. Our Meso Scale Assay expertise will ensure that your get farther along the regulatory submission process without spending more.

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                                                      Expected Services Turnaround

                                                      We whole-heartedly cooperate with your team to accomplish our shared goals and accelerate your Meso Scale Immunogenicity/PK/Biomarker study timeline. For example, we need just six-to-eight weeks for ADA assay development and validation. Afterward, we need a couple of weeks for submitting your audited report with complete details of validation experiments. Here, we pull together our core strengths – scientific experience, regulatory expertise, and operational excellence – to make sure your resources and costs are optimized.

                                                      Requested Sponsor Input

                                                      Our team thrives on open lines of communication between sponsors and our frontline scientists, project managers, lab staff, etc. Could you please share additional details about your analyte(s), preferred critical reagents and MSD assay supplies, current meso scale assay (s), data from previous run(s), study protocols (with # of cohorts, samples), etc to expedite outlining the scope of work for quotation and timeline estimation?

                                                      Reviews From Sponsors of Our Meso Scale Discovery (MSD) Assay 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.Director, 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 Director, 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.

                                                      Director, 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.

                                                      Explore Our Process & Results Driven Mindset for Fit Evaluation & Data Delivery!

                                                      Our Experienced Scientists Are Ready To Help You, Today!
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                                                      Efficiently Accelerate Your Meso Scale Discovery PK, Immunogenicity, and MSD Cytokine Multiplex Analysis With Our Bioanalytical Experts

                                                        Custom Meso Scale Assay Services

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

                                                        MSD Assay Development Expertise

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

                                                      Meso Scale Discovery: ECL Multiplex Assays For Cytokine ELISA, Immunogenicity, & PK

                                                      Meso Scale Discovery Electrochemiluminescence (ECL) Assays are an excellent singleplex and multiplex platform for assessing target analytes in complex biological samples. The platform offers ultra-low analyte detection….

                                                      Read More at our Learning Center

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

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                                                      Why Choose Us For Your Meso Scale Discovery Assay?

                                                      Prompt & Robust MSD Method Development And Validation At FDA Audited Lab!!

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                                                      • Swift MSD Cytokine, PK, Immunogenicity Assay Development And Fit-For-Purpose Validation Over A Broad Dynamic Range
                                                      • Ultra-Sensitive GLP Or Research Use (RUO) MSD Analysis Leveraging Electrode Plate Binding And Sulfo-Tag Detection
                                                      • Small Volume Based Meso Scale Discovery Assay Services For Your Preclinical and Clinical MSD Cytokine, PK, And Immunogenicity Sample Testing & Screening
                                                      • High-Impact Meso Scale Discovery Multiplex ELISA Services For Your PD Biomarkers Or Mechanism-Of-Action Studies in Cell & Tissue Lysates

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                                                      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 Meso Scale Assay Lab CRO Services?

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                                                      Related FAQs

                                                      Answers To Additional MSD Assay Questions Popular Among Our Potential Clients.

                                                      What is Meso Scale Discovery (MSD) Assay?

                                                      Meso Scale Discovery is a robust platform to measure molecules in complex biological samples. Meso Scale Discovery assays can help you profile biomolecules such as intracellular signaling proteins and cytokines. Meso Scale Discovery combines electrochemiluminescence detection with multi-array technology to provide unsurpassed sensitivity and multiplexing capacities, making it an ideal detection platform for drug discovery and development studies. The Meso Scale Discovery multiplex system offers a wide range of assay options, including MSD immunogenicity assay, MSD cytokine assays, MSD PK assay, MSD ADA assay, and MSD cell-based assays.

                                                      With 20+ years of experience developing sensitive immunoassays, NorthEast BioLab is committed to providing robust Meso Scale Discovery multiplex assays for measuring analytes such as biomarkers, phosphoproteins, and cytokines in complex biological matrices. Moreover, we offer MSD assay development and MSD assay optimization services to support and accelerate your drug development timelines. As your assay partner, we help you develop robust MSD assay protocols for high-quality MSD analysis even in the most challenging situations.

                                                      Our MSD multiplex assays provide greater analytical performance and customer value. We design numerous MSD assays, such as MSD biomarker assay, MSD ADA assay, MSD cytokine assay, and MSD PK assay, based on a variety of pharmacological and biomedical needs. Additionally, our MSD multiplex ELISA assays eliminate technical issues associated with other platforms while offering superior reliability, higher accuracy and sensitivity, and faster workflows. Besides, Multi-Spot panels in MSD ELISA assays provide multiplexing capacities to analyze multiple analytes simultaneously.

                                                      A majority of Meso Scale ELISA assays are sandwich-based assays. MSD labs employ assays such as Meso Scale PK and Meso Scale cytokine multiplex assays to evaluate drug concentrations in biological samples. In MSD cytokine analysis, the MSD method can be processed conveniently through 96-well or 384-well microtiter plates. Let us now dive deep into the working of MSD assays such as Meso Scale pharmacokinetics assay and Meso Scale PK assay.

                                                      MSD has a proprietary platform for measuring analytes in complex study samples. This technology has assays such as MSD cytokine multiplex assays to profile cytokines and cell signaling molecules, having a direct impact on drug development initiatives. MSD analysis consists of two crucial components, electrochemiluminescence detection, and Multi-array technology.

                                                      Electrochemiluminescence detection provides enhanced sensitivity, a broader dynamic range, and convenient sample analysis. It employs electrochemiluminescent labels that generate light when stimulated under appropriate conditions. This reaction is the basis of all MSD assays to measure important biomedical molecules. Moreover, MSD assays are highly reliable and provide accurate data in a broad range of sample types.

                                                      Multi-array technology is the combination of electrochemiluminescence and multiple arrays. This union brings speed and highly dense biological information. When applied to multi-spot plates, this technology can precisely quantitate several analytes in a single assay volume. Multi-spot MSD plates have arrays within each well. Each well can have up to 10 spots. Hence, a 96-well or 384-well assay plate can analyze numerous study samples, saving precious biological samples and reagents.

                                                      Moreover, MSD has two reliable instruments in its arsenal, MESO SECTOR S 600MM and MESO QuickPlex SQ 120MM. Both these instruments offer robust performance and enhanced reliability. Besides, these instruments work on efficient software designed for analyzing high-quality study data.

                                                      What biomarkers can be analyzed on the Meso Scale Discovery (MSD) Platform?

                                                      Meso Scale Discovery (MSD) assay is well suited for analyzing a wide array of biomarkers. We can run over 500 pre-validated MSD biomarker assays for a wide range of therapeutic applications, including immunology/ inflammation (cytokines and chemokines), intercellular signaling, cardiology, toxicology, and metabolic disorders. Our scientists can perform these MSD assays for a single analyte or multiplex with up to nine other compatible meso scale discovery biomarker assays. You can find a representative list of available analytes for different species here. For illustration, the table below highlights validated MSD cytokine and Alzheimer’s disease panels that can be adapted to suit your research needs.

                                                      Multiple Assay Biomarkers
                                                      V-plex Human Proinflammatory panel 1 IFN-y, IL-10, IL-12p70, Il-13, IL-1b, IL-2, IL-4, IL-6, IL-8, TNF-α
                                                      V-plex Alzheimer’s disease (Ab Peptide Panel) Aβ38 (4G8), Aβ40 (4G8), Aβ42 (AG8)

                                                      What is Meso Scale Discovery (MSD) Assay Platform?

                                                      Meso Scale Discovery Assay is a bioanalysis platform that utilizes electrochemiluminescence, unlike the colorimetric or chemiluminescent reaction in ELISA, as a signal detection technique. MSD ECL Assays are superior to traditional ELISA in many aspects, even as the various viable assay versions are quite like different types of ELISA. MSD Quick Plex 120 instrument applies the robust and sensitive electrochemiluminescence technology to quantitate single and multiple target analyte. MSD Assays enable accurate determination of analytes in complex biological matrices with improved throughput in a cost-effective and timely manner. Specifically, we can use MSD to analyze many clinically proven biomarkers, perform PK/TK analysis, and carry out ADA immunogenicity testing in a broad range of sample types such as blood, serum, and tissue, etc.

                                                      MSD ECL allows simultaneous multiplexing of up to 10 different analytes within the same well. Thus, the MSD platform requires 50-fold less sample than an ELISA method. Below, please see other crucial benefits of the Meso Scale Discovery technology –

                                                      • Absolute quantitation, short processing time, and low sample requirement (~10µl)
                                                        • High standardization from simple protocols resulting in superior inter-laboratory reproducibility
                                                        • Less time/labor intensive for scalability to larger lots
                                                        • Low sample volume from human, rodent (mice, rat) and non-rodent (NHP, dog) species
                                                      • Higher sensitivity, better dynamic range, and reduced signal-to-noise ratio
                                                        • Low analyte levels in small sample volumes
                                                        • High/low abundance analytes (normal vs. elevated) within the same sample given large dynamic range
                                                        • Limited matrix effect in serum, plasma, tissue culture media (TCM), and various other complex biological matrices
                                                      • Ready-made single analyte and multiplex kits with excellent performance and lot-to-lot consistency
                                                        • Fit-for-purpose MSD portfolio: 400+ MSD V-plex (pre-validated), U-plex (personalized multiplex), R-plex (not multiplexed), and S-plex (ultra-sensitive) assay
                                                      • Most suitable to detect low-affinity anti-drug-antibodies (ADA)
                                                      • Emission at ~620 nm solves any color quenching problems

                                                      How are Meso Scale Discovery (MSD) Immunogenicity (ADA) Assays developed?

                                                      MSD immunogenicity assays rely on a bridging assay format to detect anti-drug antibodies. First, we prepare a master mix with optimized concentrations of both the biotinylated and SULFO-TAG™ labeled drug. Our scientists then incubate the master mix and ADA reference standard or preclinical/clinical samples with the anti-drug antibody in a 96-well polypropylene plate. Thus, the anti-drug antibody bridges together the capture and detection labeled drug in MSD immunogenicity assays. Afterward, we add the incubation mixture to a blocked streptavidin plate and repeat an incubation before washing it. At this time, we are ready to quantitate the ADAs by electrochemiluminescence using the using read buffer on the meso scale discovery (MSD) platform. Generally, we can detect even low-affinity anti-drug antibodies using MSD assay as the protocol only requires one wash step. Furthermore, meso scale discovery immunogenicity assays do not use any species-related secondary antibodies, expanding its utility from preclinical to clinical studies.

                                                      What are the various optimization parameters for Meso Scale Discovery (MSD) Assays?

                                                      Meso Scale Discovery assay fundamentally utilizes the principles of enzyme-linked immunosorbent assays (ELISA) to detect analytes. Thus, proper reagent labeling, material storage, equipment usage, protocol adherence, and assay technique are crucial for optimal results with all MSD ELISA assays. Applied to standard use cases, mesoscale discovery multiplex and singleplex assays come optimized for antigen-antibody binding and detection in various matrices. However, determining suitable diluents and dilution factors can become critical for detecting novel analyte combinations in untested biological matrices. Similarly, two technical aspects of an MSD assay’s success are not stacking the plates and shaking the plates at the correct speed for optimal binding. Reverse pipetting and pipetting to the bottom corner of each well is strongly recommended for all steps of an MSD assay to prevent the formation of air bubbles. These air bubbles may interfere with the light emitted from SULFO-TAG™ on the meso scale discovery platform that uses electrochemiluminescence to detect analyte concentrations. Our scientists can also develop custom MSD immunoassays to suit your research needs. For all MSD ELISA assays, a matched antibody pair is essential to success. Generally, each MSD assay must get optimized for capture and SULFO-TAG detection antibody concentrations, incubation times, blocking and read buffers, and dilution factors.

                                                      What are the Acceptance Criteria for a Robust Meso Scale Discovery (MSD) Assay?

                                                      Meso Scale Discovery (MSD) immunoassay acceptance criteria are similar to that for other ligand based assays (LBA) as per i) FDA Bioanalytical Method Validation Guidance for Industry (May 2018) as well as ii) Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection (Jan 2019). We rigorously evaluate the accuracy and precision for each analyte in the meso scale discovery multiplex panel. Our scientists strictly follow MSD immunoassay protocols to establish duplicated seven-point calibration curves and negative controls using provided materials. We can include an additional calibrator at the lower concentrations for increased sensitivity in a meso scale discovery assay. Here, the calibrator/standard curves are evaluated using a 4-parameter logistic model, and each standard/control must have a deviation ± 20% of the nominal value. Also, the coefficient of variation between replicates should be ± 20%. Similarly, our scientists can add three to six positive controls in the QC samples to evaluate spike recovery, dilution linearity, matrix effects, and process stability. Furthermore, each MSD Assay gets rigorously assessed for the run-to-run variability.

                                                      How are MSD Biomarker and PK Assays Validated?

                                                      MSD biomarker and PK assays are based on the principles of traditional ELISA. Thus, MSD assay method validation must be fit for purpose (FFP) and follow the FDA Bioanalytical Method Validation Guidance for Industry (May 2018). Ahead of assay validation, we perform method development, optimization, and validation preparation with multiple lots of assay materials for an acceptable bioanalytical outcome. For each Meso Scale Discovery immunoassay or sponsor-developed custom MSD assay, method validation starts with verifying appropriate critical reagents, calibrators, and controls. Then, each Meso Scale Discovery multiplex assay gets evaluated for accuracy and precision. The accuracy is assessed by treating each Meso Scale Discovery standard as an unknown and back-calculating the concentration using the standard curve. According to regulatory guidelines, the calculated value’s ratio (recovery) to the expected value should be within ± 20% (±25% LLOQ and ULOQ) of the nominal value. The precision of each standard, calibrator, and study sample is based on the calculated coefficient of variation (%CV) and should be no more than ±20% (±25% LLOQ and ULOQ). As needed, we perform sensitivity, selectivity, specificity, matrix effects (linearity and spike recovery), inter and intra-day variation, and sample stability to validate your MSD multiplex assay further.

                                                      How are MSD Immunogenicity (ADA) Assays Validated?

                                                      An essential part of the drug development on Meso Scale Discovery (MSD) or other platforms is identifying and characterizing immunogenicity by measuring Anti-Drug Antibodies (ANA). Thus, our scientists follow the latest FDA guideline, namely Immunogenicity Testing of Therapeutic Protein Products — Developing and Validating Assays for Anti-Drug Antibody Detection (Jan 2019) in your preclinical and clinical studies. These guidelines ensure that the assay parameters (i.e., accuracy, precision, drug tolerance, specificity, and selectivity) for the chosen MSD Immunogenicity Assay type are appropriate for the intended purpose. One critical step in the MSD Assay validation process is using clinical samples to determine the cutoff for screening and confirmatory assays. For ANA screening, our scientists suggest a cutoff to provide a 5% false-positive rate. This cutoff helps identify individuals that may develop an immune response to a therapeutic protein. We lean towards a cutoff for confirmatory Meso Scale Discovery (MSD) Electrochemiluminescence Assays that decreases false-positive samples that may arise from non-specific binding. In summary, NorthEast BioLab team strictly adheres to FDA recommended tiered immunogenicity testing strategy (screening, confirmation, and titration) for your MSD Immunogenicity Assay validation.

                                                      What are the advantages of choosing V-PLEX, U-PLEX, R-PLEX, and S-PLEX MSD Kits?

                                                      All Mesoscale Discovery Immunoassays are based on ECL technology and provide a broad dynamic range and accurate results from a minimal sample volume. The Meso Scale Discovery multiplex assays are offered in five typical assay formats depending on your needs and applications:

                                                      V-PLEX: These are the highest quality assay panels from MSD. They are validated according to fit-for-purpose principles and contain controls with acceptance criteria to monitor plate-to-plate variability. These assays are available as a single validated assay or as part of a multiplex panel. All V-PLEX panels, including MSD cytokine assays, have been validated for serum, plasma, urine, and cell culture supernatants for multiple species.

                                                      U-PLEX: This assay format is the most flexible and allows you to customize your own Meso Scale Discovery multiplex panels. You can create panels of up to ten (10) compatible analytes from a comprehensive MSD biomarker assays menu or with custom antibody pairs. Meso Scale Discovery U-PLEX immunoassays are available in multiple species and demonstrated to work on serum, plasma, and cell culture supernatants.

                                                      R-PLEX: These kits provide matched antibody pairs for building your own customized MSD assay. Each R-PLEX kit contains a biotinylated capture antibody, a detection antibody conjugated to a SULFO-TAG™, reference calibrators, and recommended diluents. Sometimes, it’s possible to perform these highly sensitive R-PLEX assays in an open spot on a U-PLEX panel as per your sample dilution requirements.

                                                      S-PLEX: This small group of MSD assays specializes in ultra-sensitive singleplex assays that can reduce the lower detection limit by 10-1000 fold. These assays involve using reagents that help enhance and generate the assay signal on the Meso Scale Discovery (MSD) platform.

                                                      T-PLEX: These MSD assays are ready to use single and disease-specific multiplex assays that include some of the most widely studied analytes. These Meso Scale Discovery multiplex panels are available for various species and are compatible with a broad range of sample types to study both secreted and intracellular biomarkers.

                                                      What Types of Plates are Available for Custom Meso Scale Discovery (MSD) Assays?

                                                      Meso Scale Discovery electrochemiluminescence platform offers two types of plates: SECTOR plates and QUICKPLEX plates. MSD ELISA assays developed on SECTOR plates are read by reading sectors of 4 wells at a time. These plates come in single spot wells for MSD single-plex assays and multi-spot wells (4, 7, or 10) for MSD multiplex assays. The spots at the bottom of each well consist of an electrode that binds to a specific capture reagent for each Meso Scale Discovery assay (MSD) assay. Our scientists can coat the plates with various capture molecules such as antibodies, antigens, peptides, and lysates. After coating, we add the sample and detection antibody conjugated to Meso Scale Discovery electrochemiluminescence tag (SULFO-TAG™) over a series of incubation and wash steps. Once the assay is complete and read buffer is added, MSD platform applies a voltage to the plate’s electrodes to activate the SULFO-TAG™ for detection. QUICKPLEX is a newer single spot plate design that reads only one well at a time, and that’s intended for the development of a custom MSD assay.

                                                      Furthermore, MSD ELISA plates are available in three different surface types: standard streptavidin, small spot streptavidin, and high bind avidin. Both Streptavidin plates consist of a hydrophobic surface that contains a binding capacity of up to 1.0 pg/mol per one 96 plate well. In comparison, high bind avidin plates consist of a hydrophilic surface that exhibits a binding capacity of up to 5.0 pg/mol per one 96 plate well. Generally, Streptavidin plates offer higher sensitivity, while high bind avidin plates allow the detection of higher concentrations of analytes. Small spot streptavidin plate provides the highest MSD ELISA assay sensitivity. We recommend testing all relevant microtiter plates depending upon identified coating concentration and assay sensitivity requirements during your MSD assay development and validation.

                                                      How do you develop a Meso Scale Discovery (MSD) Assay from an existing ELISA Assay?

                                                      Meso Scale Discovery (MSD) platform is designed for easy method transfer of an existing ELISA protocol to MSD assay. Among other considerations, we need two alterations when transferring an ELISA to MSD ECL assay. The capture reagents (directly or indirectly through a biotin label) must bind a spot on the plate containing an electrode. The detection antibody must also include a SULFO-TAG™ that emits light when the electricity gets applied to the electrode. Once both antibodies are slightly modified to meet the outlined criteria, the assay conditions need to be optimized for capture antibody concentration, the volume of capture antibody per well, and detection antibody concentrations. After the MSD assay is optimized, our scientists will revalidate the assay with a fit-for-purpose approach for parameters such as accuracy, precision, sensitivity, matrix effects (linearity and spike recovery), and sample stability. At this time, our newly transferred MSD ELISA assay is ready for analysis of your study samples.

                                                      Why Choose a Meso Scale Discovery Multiplex Assay over an ELISA Assay?

                                                      Meso Scale Discovery (MSD) Assay platform offers numerous advantages over traditional ELISA. Generally, MSD ELISA assays exhibit higher sensitivity and precision, a more comprehensive dynamic range (3-4 logs), and a lower background signal than a conventional ELISA. However, one significant advantage is ability to develop custom Meso Scale Discovery multiplex panels for quantitating up to 10 analytes per well using small sample volumes (~25 uL). Moreover, MSD assays have a robust matrix tolerance. Consequently, our sponsors receive high-quality data from their various sample types, including serum, plasma, cell culture supernatant, and tissue lysates. In conclusion, MSD mesoscale assays are highly flexible and simplify workflows to enable biomarker and cytokine testing when sample volumes are limited.

                                                      How do MSD Electrochemiluminescence Immunoassays Work?

                                                      MSD Electrochemiluminescence or electrogenerated chemiluminescence is the emission of light by electrochemical assay reactions. All Meso Scale Discovery electrochemiluminescence assays (MSD ECL assays) utilize 96 well plates that contain single spot or multiple spots on the bottom of each well. These spots have electrodes that bind to various capture molecules such as antibodies, antigens, peptides, and lysates. After the capture molecules are attached to the plate, the samples and detection antibody conjugated to an MSD electrochemiluminescence tag (SULFO-TAG™) are added over a series of incubation and wash steps. Once the MSD assay is complete, the user adds a read buffer, and a voltage is applied to the plate electrodes to activate the SULFO-TAG™ for detection. Now, the emitted light intensity gets measured by the Meso Scale Discovery (MSD) platform to quantify various analyte concentrations in your study samples. Using this relatively new technology, MSD ELISA exhibits high sensitivity and a more comprehensive dynamic range than traditional methods.

                                                      How long does an MSD Immunoassays Assay Take?

                                                      Each singleplex and multiplex Meso Scale Discovery electrochemiluminescence assay (MSD ECL assay) is designed to have a simple assay protocol and efficient turnaround time. Most MSD assay protocols are optimized such that the user can complete the time from sample preparation to reading quantitative results in a typical workday. Although incubation times between diverse MSD ELISA assays can vary, these are carefully controlled and monitored to retain high inter-assay accuracy and precision. Typically, MSD assays have a higher sensitivity and a more comprehensive dynamic range to avoid multiple dilutions for multiplex assays, even as they take a similar amount of time when compared to a traditional ELISA. Furthermore, the MSD multiplex platform is advantageous as compared to multiplex bead-based methods. Notably, Meso Scale Discovery (MSD) platform takes only 1 1/2 minutes to analyze a 96 well plate, while bead-based assays can take up to 1 hour.

                                                      How many calibrators and control samples are recommended for Meso Scale Discovery (MSD) Assays?

                                                      We recommend each microtiter plate contain at least a Seven (7) point calibrator/standard curve that encompasses the dynamic range of the Meso Scale Discovery electrochemiluminescence (MSD ECL) assay. Also, each MSD ELISA plate should include at least three positive controls and negative control with untreated matrix. At a minimum, we prepare three positive controls by serially diluting the highest concentration calibrator in your sample matrix to produce a high (≤70 % highest concentration), middle, and low (2-3 times lowest standard concentration) quality control sample. Notably, our scientists analyze all MSD assay calibrator and quality control samples in duplicate on the Meso Scale Discovery platform to assess precision and accuracy. For MSD mesoscale multiplex assays, the calibrators and quality controls are established for each analyte quantitated. Our standard operating and quality control procedures ensure that each analyte’s MSD assay is robust and provides reliable results for your precious study samples.

                                                      Do you recommend MSD Assay sample analysis in duplicate or triplicate?

                                                      We recommend preparing the calibration standards and samples at least in duplicate to evaluate possible variation and allow course correction for each Meso Scale Discovery (MSD) assay. After assessing your duplicated standards and samples on the meso scale discovery (MSD) platform, our scientists can be confident of assay performance by calculating various concentration summary parameters such as average, standard deviation, coefficient of variation (%CV), etc. According to GLP guidelines, the replicated samples should have a % CV concentration under 20%. Usually, these FDA guidelines ensure that the data obtained from your MSD ECL assay is precise. Here, the %CV gets calculated for each analyte in your MSD multiplex assay. Sometimes, our sponsors request sample analysis in triplicate when the chosen matrix contains a high level of interferents, or the assay precision is uncertain.

                                                      Can tissue samples be analyzed with an MSD Immunoassay?

                                                      We can apply Meso Scale Discovery (MSD) assays to analyze biomarkers in various biological matrices such as blood plasma, serum, urine, CSF, saliva, synovial fluid, and cell lysates, etc. Additionally, our scientists can use MSD assays to test tissue lysates. Here, the lysate sample preparation varies by tissue type, and our experts may recommend certain protease inhibitors to avoid degradation. Before launching the usual meso scale assay protocol, we quantitate the total protein through a Bradford/BCA assay and dilute its concentration to 12.5 ug/mL per well using recommended buffers. That said, most V-PLEX meso scale discovery electrochemiluminescence assays have only been validated for serum, plasma, urine, and cell culture supernatant matrices.

                                                      How is Meso Scale Discovery data processed and distributed to sponsors?

                                                      Meso Scale Discovery platform uses Methodical Mind software for data acquisition and Discovery Workbench software for data processing and reporting. When the data collection is complete, our scientists analyze each analyte’s calibration curve for accuracy and precision of the meso scale discovery immunoassay. We only share study results with the sponsor if the calibration curves and %CV from replicates are acceptable. Usually, our meso scale discovery electrochemiluminescence (MSD-ECL) assay reports include:

                                                      • Tables and Charts containing raw quantitation data
                                                      • Summary of immunoassay conditions
                                                      • Catalog and lot number of MSD kits

                                                      Furthermore, each assay’s raw data file includes concentration statistics, such as mean, standard deviation, and %CV for each calibration standard, quality control, and study sample. As needed, we can create a formal and audited hyperlinked PDF report. Our scientists are glad to help if you have any additional questions concerning documentation and reporting of your Meso Scale Discovery project results.

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