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Bioanalytical assay development helps determine the design implications, limitations, favorable conditions, and suitability of a drug for the intended treatment. Before biological assay development and validation can be initiated, it is recommended to understand the physiochemical properties of the analyte. Bioanalytical assay development is considerably informed by the details on protein binding and in vivo/in vitro metabolism along with essential aspects of prior work on the method. Bioanalytical assays play a crucial role in the discovery and development of pharmaceutical products given their ability to discern purity, identity, performance, and potency of these compounds. Furthermore, the involved techniques allow reproducible and reliable quantitation of analytes in various biological matrices, such as plasma, urine, blood, or serum.
In vitro assay development is another critical component in the bioanalytical process. It involves creating and optimizing assays that can accurately mimic the biological environment of the analyte in a controlled laboratory setting. This step is vital for understanding the drug’s behavior under specific conditions and ensuring that the assay is suitable for its intended purpose.
Biological Assay validation services and assay qualification are performed for the analysis of drugs, metabolites, and biomarkers to ensure that the test results are precise and accurate, and the generated data is reasonably robust in supporting drug development and other intended purposes. Several method characteristics play a significant role during each stage of biological assay development and validation, including specific chemistry of analyte, sample clean-up to analysis methodology, and desired method sensitivity. The selectivity and sensitivity of bioanalytical assays developed for drug and metabolite quantitation thoroughly impact the success of preclinical and clinical studies. Thus, careful sample preparation, HPLC column, and mobile phase selection, and choice of detector and quantitation method are critical during LC-MS assay development.
The purpose of assay development, validation, and assay qualification is to find a suitable method applicable to a chosen analyte in a specific biological matrix. The analysis outcome might be inaccurate if the assay is not validated correctly and deemed unreliable. This assay inadequacy could be due to low sensitivity, selectivity, precision, accuracy or any other reason. Given the significance of this topic, the FDA has published guidance to provide guardrails around assay development and validation discussions. Generally, the assay can be used with full confidence to produce reliable data if the FDA method development guidance is followed and all its outlined criteria are met. Thus, assay development and validation are carried out with appropriate technology so that compliance with regulatory and scientific requirements can be achieved. Additionally, analytical information obtained from already existing bioanalytical assays may sometimes be effectively utilized.
In vitro assay development is also a critical aspect of this process. By designing assays that replicate the biological environment in controlled conditions, researchers can better understand how an analyte behaves in vitro, leading to more accurate and reliable data. This step is essential in ensuring that the assay is not only suitable for its intended use but also compliant with regulatory guidelines.
In summary, bioanalytical method development and validation enable reliable quantitation of analytes and biomarkers in various biological matrices to test drug safety and efficacy. We understand your invaluable bioanalytical assay data is reproducible and dependable only if generated using fully validated methods and platforms by qualified scientists. NorthEast BioLab offers meticulous assay development and assay qualification for your PK, TK, immunogenicity, or biomarker testing needs.
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“NorthEast BioLab is the most responsive and thorough bioanalysis lab services CRO.”
NorthEast BioLab is a responsive, collaborative, and reliable partner
We trust NorthEast BioLab to design and execute streamlined, impactful bioanalytical projects
We found their integrity as refreshing as readiness to provide creative scientific input and high-quality data
We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.
NorthEast BioLab tremendously supported us in reproducing our critical lab discoveries for drug metabolism
NorthEast BioLab always exceeds expectations on bioanalytical assay development, validation, and sample analysis.
“NorthEast BioLab goes the extra mile. We look forward to more meaningful collaborations.”
NorthEast BioLab offers a science-based, hands-on approach to the latest bioanalytical platforms
We are thrilled to complete our bioanalytical studies with their top quality and incredibly responsive team.
We worked closely to implement the most efficient and cost-effective bioanalytical assay for our PK Studies.
Our projects with NorthEast BioLab include successful method development, validation, stability studies during Clinical Phase I – IV studies.
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.
Our latest successful study was a pivotal bioequivalence study, where samples from a cross-over study with about 100 volunteers needed swift analysis.
This study, same as all other bioanalytical studies, was completed with top quality and reporting standard with incredible responsiveness.
NorthEast BioLab’s scientists deliver high-quality data on time and within budget
NorthEast BioLab offers comprehensive bioanalytical assay services at every stage of drug development during drug discovery, preclinical and clinical studies. Our scientists assist in assay development services and validation for quantitation of analyte and metabolites for blood, plasma, serum, urine, and cerebrospinal fluid (CSF) samples among other standard matrices. Our bioanalytical method development and validation services can be utilized for small and large molecules, such as NCE, biosimilars, peptides, antibody drug conjugates (ADC), monoclonal antibodies (mAb), and oligonucleotides.
Our custom biomarker development services support analysis using proprietary or commercially available materials, such as anti-ID antibodies or antibody pairs from the sponsor. Depending on study needs, our scientists can set-up your biomarker assays individually (single-plex assay) or combined to simultaneously analyze multiple analytes (multi-plex assay) on MSD ECL or Luminex Multiplex platform. Each project begins by consulting with our biomarker lab experts to determine the analytes(s) of interest, the species/sample matrix, sample quantity, QC requirements, dynamic range, and assay platform. Afterward, a preliminary run consisting of a standard curve and QC samples is performed to assess project feasibility with desired multiplexing or dilution.
Once method development and protocol optimization are complete, we perform biomarker validation services to measure bioanalytical parameters such as accuracy, precision, and recovery. Afterward, NorthEast BioLab issues a hyperlinked biomarker method validation pdf report documenting your eCTD submission-ready assay. Henceforth, your fully validated and robust biomarker assay is reliable for all phases of the drug development, from GLP preclinical studies to clinical biomarker testing.
Similarly, we understand that you may have validated ELISA assays to be transferred on a multiplexing biomarker assay platform. Both the Luminex and MSD platforms benefit from the traditional ELISA assay but offer significant advantages of using smaller sample volumes to analyze multiple analytes simultaneously. Consequently, these platforms lead to increased throughput, reduced costs, and more flexibility. Our team of scientists can also seamlessly transfer your existing ELISA assays to either the Luminex or MSD multiplex platforms. The transferred assay can then be used alone or combined with other biomarkers to create a panel to meet your unique drug development and research needs.
The Enzyme-Linked Immunosorbent Assay (ELISA) method helps determine and quantify macromolecules, such as proteins and peptides. Here, a capture and detection antibody pair are connected to the enzyme that accomplishes catalysis of a chemiluminescent or colorimetric substrate. Our veteran scientists at NorthEast BioLab utilize ELISA methods for determining the concentration and presence of the analyte in biological samples for a variety of drug research and development studies.
We provide comprehensive biomarker assay development and validation services, given our deep expertise in analyzing various analytes in multiplex and singleplex formats such as LC-MS/MS, ELISA, MSD ECL Assay, Luminex Assay, or qPCR for multiple therapeutic areas and species. Our biomarker testing services include method development and assay validation for novel biomarkers, development of tissue and fluid-based biomarkers, as well as GLP and GCP biomarker assessments.
At NorthEast BioLab, we offer a comprehensive solution for immunogenicity testing including ADA screening, confirmation, titration, and isotyping. Our scientists diligently assess the immunogenicity of your drug product, calculate the analysis cutpoint, evaluate the formation of anti-drug antibodies, and measure the persistence of the neutralizing fractions of anti-drug antibodies.
At NorthEast BioLab, we utilize in vitro and in vivo ADME studies to evaluate the dosage regimen, administration routes, and safety assessment of the drug on different types of species. A dedicated study is developed by our lab analysts to cater to the requirements of your program.
NorthEast BioLab performs various cell-based proliferation viability assay for metabolic activity analysis, DNA replication, antigen recognition, proliferation markers, membrane integrity, and ATP measurements. Our services in this domain include signaling and secretion, apoptosis and cell death, and cell proliferation assay.
NorthEast BioLab provides biomarker testing services with an exhaustive menu of 600+ analytes in the usual biological matrices, given the attractive risk/reward profile of commercial assays. We offer biomarker analysis services using a singleplex or multiplex panel for a wide range of applications such as immunology/inflammation, cardiology, toxicology, and metabolic disorders. Furthermore, our preclinical and clinical biomarker services include cytokine testing in humans, mice, rats, dogs, pigs, non human primates (NHP), and other species.
NorthEast BioLab’s committed to delivering the best possible outcome for your biomarker services on MSD and Luminex platforms, keeping pace with the latest technological advances that allow multiplexing from a single sample with a small volume. Our scientists closely partner with industry-leading kit providers (Meso Scale Discovery, Millipore Sigma, Thermo Fisher Scientific, R&D Systems, Biorad, etc.) to accurately analyze your biomarker study samples. Thus, our vendors’ technical support empowers us to provide reproducible and reliable results using pre-validated biomarker panels or custom assay panels even for your most challenging biomarker services.
We can perform these biomarker lab services according to manufacture specifications or customize protocol to meet your bespoke research and development goals. Before biomarker analysis on your precious study samples, our team conducts a pre-validation run to optimize assay, such as determine minimum required dilution (MRD) and assess quality controls against standard curve to gauge % recovery. Per your regulatory requirement, we happily perform biomarker validation services on these commercial assays to thoroughly analyze bioanalytical parameters such as accuracy, precision, sensitivity, dilution effects, etc.
One of our most popular biomarker services is Cytokine testing, which is a crucial part of many research studies capturing the expression of immune and inflammatory responses. We offer multiple cytokine assay profiling services on both Meso Scale Discovery (MSD) and the Luminex platforms. These biomarker development and validation services are fully customizable and range from small panels containing a few cytokines of interest to larger pre-validated cytokine profile panels. Below, please find some of our standard cytokine testing panels.
| Panel | Assay Platform | Analytes |
|---|---|---|
| V-plex Mouse Cytokine 19-plex | MSD | IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12p70, IL-15, IL-17A/F, IL-27p28/IL-30, IL-33, IP-10, KC/GRO, MCP-1, MIP-1α, MIP-2, TNF-α |
| V-plex Human Biomarkers 54-plex | MSD | CRP, Eotaxin, Eotaxin-3, FGF (basic), GM-CSF, ICAM-1, IFN-γ, IL-1α, IL-1β, IL-1RA, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-8 (HA), IL-9, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A, IL-17A/F, IL-17B, IL-17C, IL-17D, IL-21, IL-22, IL-23, IL-27, IL-31, IP-10, MCP-1, MCP-4, MDC, MIP-1α, MIP-1β, MIP-3α, PlGF, SAA, TARC, Tie-2, TNF-α, TNF-β, TSLP, VCAM-1, VEGF-A, VEGF-C, VEGF-D, VEGFR-1/Flt-1 |
| Multiplex Mouse Cytokine/Chemokine Panel | Luminex xMAP | GM-CSF, IFN-γ, IL-1α, IL-1β, IL-2, IL-3,IL-4, IL-5, IL-6, IL-7, IL-9, IL-10, IL-12 (p40), IL-12, (p70), IL-13, IL-15, IL-17, IP-10, KC, LIF, LIX, MCP-1, M-CSF, MIG,MIP-1α, MIP-1β,MIP-2, RANTES, TNF-α,VEGF, Eotaxin/CCL11 |
| Milliplex Human Cytokine/Chemoskine/Growth Factor Panel | Luminex xMAP | sCD40L, EGF, Eotaxin, FGF-2, Flt-3 ligand, Fractalkine, G-CSF, GM-CSF, GROα, IFNα2, IFNγ, IL-1α, IL-1β, IL-1ra, IL-2, IL-3, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p40), IL-12 (p70), IL-13, IL-15, IL-17A, IL-17E/IL-25, IL-17F, IL-18, IL-22, IL-27, IP-10, MCP-1, MCP-3, M-CSF, MDC (CCL22), MIG, MIP-1α, MIP-1β, PDGF-AA, PDGF-AB/BB, RANTES, TGFα, TNFα, TNFβ, VEGF-A |
In summary, NorthEast BioLab offers diverse biomarker testing on multiple biomarker assay platforms. We can analyze client samples for one or two analytes individually using traditional ELISA methods or multiplex biomarkers to create panels to maximize study ROI with high integrity data using small sample volumes. All biomarker studies are validated with a fit for purpose approach to fulfill your regulatory needs. Contact us today to discuss your biomarker research needs, whether you are at the discovery phase or getting ready for clinical analysis.
At NorthEast Biolab, we recognize the pivotal significance of bioanalytical assays in drug discovery and development for measuring the efficacy and safety profile of your drug compounds in biological samples. Accordingly, our scientists develop reliable analytical methods suitable for the various stages of your drug development. For example, we offer expedited assay development and sample analysis for your drug discovery and molecule screening needs. Similarly, we perform full biological assay validation with strict adherence to bioanalytical method validation (BMV) regulatory guidelines during preclinical safety, toxicokinetic assessments, and clinical trials.
Additionally, we initiate our bioanalytical assay services only after developing a thorough understanding of your study requirements to yield high-quality results promptly. For small molecules, we widely utilize the LC-MS/MS method that doesn’t need extensive sample preparation. In this case, a suitable mass spectrometry setup is chosen based on the required assay sensitivity and specificity. For large molecules, we have in-depth expertise in biological assay validation of both customized ELISA and commercially available ELISA kits as needed. Here, the calibration range of the assay is chosen based on the expected concentration to minimize the reanalysis of study samples. Our team offers you outstanding support and maintains constant communication to smoothly meet your project-critical deadlines utilizing our robust techniques and scalable sample analysis platforms.
Bioanalysis is an essential tool in drug discovery and development for determining the concentration of drugs and their metabolites as well as various pharmacodynamics biomarkers in biological fluids. In these analyses, scientists use developed an….
During preclinical development, bioanalytical assays assess the impact of New chemical entity (NCE) as a potential treatment on various animal species. Further in-vitro assay development and validation is required to evaluate pharmacokinetic parameters, toxicity, and safety profile in humans of the drug compound that reaches the clinical stage. Sample collection, processing, and preparation should be thoroughly assessed before starting in-vitro assay development to mitigate future risk factors at a later stage and validation phase.
Simply put, bioanalytical assays are imperative in improving a drug candidate’s success rate in preclinical animal studies. Robust assay development and validation during early preclinical studies is time well spent as satisfactory assays can be carried out further into development stages with minimal effort. Bioanalytical assays during clinical studies in human volunteers involve quantitation of analytes and corresponding metabolites as well as an assessment of various matrices. This analysis provides significant guidance on toxicokinetic and pharmacokinetic parameters evaluated through in-vitro assay development and validation.
Answers to additional Bioanalytical Assay Validation questions popular among our potential clients.
Bioanalytical assay development and qualification help determine the design implications, limitations, favorable conditions, and suitability of a drug for the intended treatment. Specifically, bioanalytical assays enable precise identification and quantitation of a compound in a biological matrix. Optimal assay development and validation involve numerous scientific and regulatory considerations, and several such methods help measure various aspects of a drug compound. We recommend understanding the analyte’s physicochemical properties ahead of starting assay development and validation. At NorthEast BioLab, we offer custom assay development and validation services for your proprietary or commercially available compound as per various regulatory guidance.
The primary intent of assay validation is to perform a regulated (GLP/GCP) study with reproducible and reliable results for sponsors. At NorthEast BioLab, we perform method validation to verify assay parameters such as precision, accuracy, selectivity, sensitivity, and stability throughout the bioanalytical testing process. We complete three/six independent validation runs over multiple days to estimate intra-day and inter-day accuracy and precision, as described in the assay validation FDA guideline white papers. All applicable experiments for reference standards and critical reagents, calibration curve, QCs, matrix effect, matrix suppression, extraction recovery, and carryover are covered as well. In-process stability experiments for bench-top, freeze-thaw cycles, and -70C stability in relevant matrices. Typically, a fully validated method is appropriate during preclinical and clinical development phases of the drug development process. NorthEast Biolab provides full assay method validation services according to FDA guidelines for both small and large molecules.
Robust bioanalytical assay development and validation are essential to accurate measurements of drugs, metabolites, and biomarkers in bioanalytical assays. Ahead of getting started, we do publication research to become familiar with drug compounds or biomarkers. For example, we must consider the nature and any relevant characteristics of the bioanalytical sample itself. Thus, the sample composition and expected concentration of the analyte constitute noteworthy criteria among several other factors. US FDA, ICH, and other regulatory agencies provide bioanalytical method development guidelines for setting up reliable bioanalytical assays. Generally, the key characteristics for the execution of an acceptable method are sensitivity selectivity, reproducibility, intra-day and inter-day precision and accuracy, dilutional integrity, matrix effects, and analyte stability under all sample storage, handling, and preparation conditions. Assay qualification demonstrates that an accepted method will provide meaningful data for the specific conditions, matrices, and samples intended for the procedure. Our veteran team of bioanalysis experts is equipped to handle full assay validation for small and large molecule according to FDA guidance.
For bioanalytical assays, the FDA, EMA, ICH, and other regulatory agencies provide biological assay development and validation guidelines outlining the required parameters for appropriate method validation and sample analysis. We evaluate parameters for sensitivity, selectivity, reproducibility, intra-day accuracy and precision, dilution integrity, matrix effect, and analyte recovery during bioanalytical testing. A full method validation study must be completed for any custom bioanalytical assay method that is new or developed based on the scientific publications. A fully validated method shows that it can determine the concentrations of analytes such as a drug, metabolite(s), or biomarkers reliably in a specific biological sample matrix from a particular species.
FDA has issued multiple guideline documents to inform the development and validation of bioanalytical assays used for nonclinical and clinical studies focused on pharmacokinetics, toxicokinetics, or biomarker data. FDA assay development guidelines apply to chromatographic assays (CCs) and ligand binding assays (LBAs) that quantitate the levels of drugs, metabolites, therapeutic proteins, and biomarkers in biological matrices such as blood, serum, plasma, urine, and a variety of tissues. Assay development and validation ensure that the data reliability by addressing certain key questions: Does the assay measure the intended analyte? What is the variability within these measurements? What range of measurements provides reliable data? How do sample collection, handling, and storage affect the data reliability for bioanalytical assay?
In assay validation there are specific parameters mentioned in bioanalytical assay validation FDA guidance. Typical method validation parameters to be considered are:
ParameterChromatographic AssaysLigand Binding Assays
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At NorthEast Bioanalytical Laboratories, we provide reproducible data for bioanalytical testing and assay validation service with full confidence to our client for regulatory submission.
Bioanalytical testing is a sub-discipline of analytical chemistry. It covers the quantitative measurement of xenobiotics (drugs and their metabolites, and biological molecules in various locations or concentrations) and biotics (macromolecules, proteins, DNA, RNA, large molecule drugs, metabolites) in biological systems. Bioanalytical method development is the quantitative determination of drugs and metabolites in biological matrices such as blood, serum, plasma, urine, tissue, and skin samples as applied to toxicology, pharmacology, bioequivalence, pharmacokinetics, and bioavailability studies in animals or humans. Immunogenicity tests are bioanalytical methods that target anti product antibodies in serum or plasma. Bioanalytical assay qualification is not intended to elucidate quality parameters (e.g., identity, purity) of a biotech product, instead bioanalytical analysis determines the quantity of a drug or the presence of induced antibodies in biological samples by using different bioanalytical techniques.
Bioanalytical assays focused on pharmacokinetics, bioavailability, toxicokinetics, immunogenicity, or biomarker testing play a crucial role in the discovery and development of drug products. We recommend understanding the physicochemical properties of the analyte before assay development and validation. Consequently, our bioanalytical techniques allow reproducible and reliable quantitation of analytes in various biological matrices, such as plasma, urine, blood, or serum. During bioanalytical testing, assay development helps determine the design implications, limitations, favorable conditions, and suitability of a drug for the intended treatment. Additionally, bioanalytical assay development gets considerably informed by protein binding and in vivo/in vitro metabolism along with essential aspects of prior DMPK/ADME work on the method. NorthEast Biolab offers comprehensive assay development services and assay validation services for your critical bioanalytical studies.
In vitro assay development is a key component in this process, allowing for the creation of assays that accurately mimic the biological environment in controlled laboratory settings. This approach helps ensure that the assay is well-suited for its intended purpose, providing reliable and reproducible data. Our in vitro assay development services are designed to meet the specific needs of your bioanalytical studies, ensuring compliance with regulatory standards and scientific rigor.
NorthEast BioLab provides comprehensive bioanalytical assay services at all stages of drug programs, including discovery, preclinical and clinical studies. We offer custom assay development services for small and large molecules, such as NCEs, biosimilars, peptides, antibody-drug conjugates (ADC), and monoclonal antibodies (ADC) mAb), and oligonucleotides. We provide full assay validation according to FDA and other regulatory guidelines. Our experienced scientists rely on sound science for bioanalytical research and assay qualification to provide high-quality and expedited bioanalytical testing to our sponsors.
We must recognize the crucial significance of bioanalytical assays in drug development for assessing therapeutic efficacy and safety. Accordingly, you must choose the provider of reliable analytical methods suitable for the various stages of your drug development and bioanalytical studies. Another criterion is whether there are any charges for expedited assay development services and sample analysis. For smoother transition down the road, your preferred vendor must offer a full GLP assay validation service with strict adherence to bioanalytical assay validation (BMV) regulatory guidelines. Generally, you would rely on a lab that initiates bioanalytical assay services only after forming a thorough understanding of your study requirements. At NorthEast BioLab, we choose the calibration range of assay based on the expected concentration to minimize the reanalysis of study samples. Find a vendor that offers you outstanding support and maintains constant communication to smoothly meet your project-critical deadlines utilizing robust techniques and bioanalytical sample analysis platforms.
