Bioanalytical Method Development includes setup, optimization, and pre-validation of chromatographic assays (CCs) or ligand binding assays (LBAs) in chosen biological matrices. As part of Method Development, we request your desired calibration range as well as prepare standards and quality control samples using your proprietary or commercially available reference materials. Furthermore, our experienced team promptly optimizes your assay method for any PK/PD analysis testing and bioanalytical parameters. Northeast BioLab scientists diligently prepare a method validation protocol and perform a pre-study test run to ensure suitability for Method Development and Validation, as needed.
Analytical method development is a procedure for reliable detection of analytes of interest. High-grade method development ensures that the method is suitable for full validation and high-quality analysis of drugs, metabolites, and biomarkers in biological matrices. Analytical development plays a crucial role in this process, ensuring that the method is optimized for accurate and reproducible results. As the number of drugs released in the market is increasing by the day, so is the need for method development and validation. These new drugs may be compounds never used before or modification of existing drugs. Inability to relate analytical procedures, as well as reference and internal standards for new drugs, hinders their thorough R&D. Hence, it becomes necessary to develop new analytical methods for studying the effect of drug compounds. These methods are designed to understand the identity, characteristics, purity, and potency of drug compounds.
During drug research, the developed analytical methods are utilized to measure and define the required dosage, acceptable impurity, observed stability, and bioavailability of the drug. Analytical development is integral to this process, ensuring that these methods are fine-tuned for accurate and consistent results. Overall, analytical method development ensures product consistency, allowing the release of reliable drug products in the market.
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NorthEast BioLab is by far the most responsive and thorough bioanalysis lab services CRO.
We partnered on several programs and found NorthEast BioLab responsive, collaborative, and reliable.
We trust NorthEast BioLab to design and execute the most streamlined and 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 truly goes that extra mile, and we hope to continue enjoying seminal interactions with them.
NorthEast BioLab presents a science-based, hands-on, no-frills approach on 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 with NorthEast BioLab, was completed with top quality and reporting standard with incredible responsiveness.
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.
Various method development techniques are utilized to analyze drugs and metabolites in biological fluids with high precision and accuracy. NorthEast BioLab offers comprehensive method development services to ensure reliable and reproducible results. Our analytical techniques definition ensures that we use the most appropriate methods for each analysis. Other parameters such as analyte stability, interaction with additional medications are also determined. Selecting the right analytical development method is imperative for the sample analysis data integrity and drug advancement in the right direction.
LC-MS/MS has become one of the most popular drug analysis technique given rapid method development on the platform. Liquid Chromatography with tandem mass spectrometry relies on their combined strengths. While liquid chromatography has excellent separation capabilities, triple quadrupole mass spectrometry offers nuanced selectivity and sensitivity.
These methods use a UV detector to analyze samples and measure their absorption ability for analyte identification. The ultraviolet (UV) detector measures the absorbance of monochromatic light of a fixed wavelength in the UV or visible wavelength range against a reference beam and relates the magnitude of the absorbance to the concentration of an analyte in the eluent passing through a flow cell contained within the instrument. The HPLC UV method is preferable for solutions that have an unknown molecule count. Similarly, drugs with analytes suitable for UV detection have good chromophore due to unsaturated bonds, aromatic groups, or functional groups containing heteroatoms. Although in some instances, this technique may be necessary, analysts prefer LC-MS/MS method development over UV, as detection can be time-consuming and transition to Clinical samples difficult due to inconsistent interferences in plasma from subject to subject.
HPLC/FL method development can be extremely swift due to the selective nature of this technique. Here, it’s possible to detect even a single analyte molecule in the flow cell. Put differently, fluorescence sensitivity can be 100x more than that of the UV detector for some specific compounds. This is typically an advantage in the measurement of fluorescent species in samples.
Enzyme-linked immunosorbent assay is a method utilized for specific proteins. The technique captures an antigen on a solid surface which is then complexed to an antibody. The detection is achieved by assessing the activity of the enzyme. Although there has been a notable shift towards using LC-MS/MS analysis for large molecules, it is still quite challenging to achieve the same sensitivity levels as with ELISA. That said, method development with ELISA can be tricky as other endogenous substances in the biological matrices interfere with analyte detection.
Meso Scale Discovery (MSD) is an advanced technology platform used to measure biomarkers with high sensitivity and precision. It offers an electrochemiluminescence (ECL) detection method that is superior to traditional ELISA in terms of dynamic range, sensitivity, and multiplexing capabilities. According to NorthEast BioLab, MSD assays can detect multiple analytes in a single sample, reducing sample volume requirements and improving throughput. This method also minimizes interference from biological matrices, making it a powerful tool for biomarker analysis, especially in cases where ELISA sensitivity is not sufficient.
qPCR and ddPCR are essential tools for precise gene expression analysis. qPCR offers relative quantification of nucleic acids, while ddPCR provides absolute quantification without standard curves. NorthEast BioLab utilizes both techniques to detect low-abundance targets and perform multiplexing for drug development and biomarker discovery. These methods are ideal for pharmacodynamics studies, ensuring accurate and sensitive nucleic acid measurements.
Both platforms offer distinct advantages, and the choice between qPCR and ddPCR depends on the project’s requirements, such as the need for absolute vs. relative quantification, sensitivity levels, and sample complexity. These techniques are particularly valuable in pharmacodynamics (PD) studies and for validating biomarkers during clinical trials.
Flow Cytometry is a highly specialized technique used to analyze the physical and chemical characteristics of cells or particles in a fluid as they pass through a laser. At NorthEast BioLab, flow cytometry-based assays are integral to biomarker analysis, immunophenotyping, and other cell-based assays. Their services include both custom assay development and optimization using commercial assay supplies. The platform allows for precise tagging of cells with fluorescent dyes, and its multiplexing capability enables the simultaneous analysis of multiple markers within a single sample.
Flow cytometry is particularly useful for immunological studies, such as measuring immune cell subsets, identifying disease states, and performing functional studies.
When it comes to analytical method development, scientists have several critical choices to make from a variety of sample preparation techniques, chromatographic conditions, and detection systems. We make every effort to develop a robust and straightforward method that can be used frequently for producing reliable results. Our analytical techniques definition outlines the methodologies we employ to ensure accuracy and consistency in each analysis. Our analytical development services are designed to guide this process, ensuring the selection of the most appropriate techniques for each specific project. The first step in method development is to select a suitable sample clean-up procedure such as simple protein precipitation. Other available options include liquid extraction or solid phase extraction. In some case, it may be necessary to use an even more involved procedure such as chemical derivatization. Once a proper sample clean-up technique is decided, suitable chromatographic conditions are selected next, followed by the determination of an appropriate detection system. Our analytical techniques definition helps guide the selection of these methods to ensure the highest level of precision and reliability. Although older detection systems such as ultraviolet (UV) and fluorescence are still in use, mass spectrometry has emerged as the detection system of choice over the last couple of decades due to its high selectivity. Through our analytical development services, we ensure that each step is optimized for accuracy and efficiency, providing reliable results for drug research and testing.
We provide precise PK analysis to understand the drug’s absorption, distribution, metabolism,
and excretion, which are critical for pharmacological profiling.
Our ADA and neutralizing antibody assays are designed to evaluate immunogenicity, ensuring accurate assessment of immune responses to therapeutic treatments.
Using sensitive and reproducible techniques, we quantify cytokines and biomarkers to provide key insights into immune responses, disease progression, and therapeutic efficacy.
Our cell-based assay development ensures accuracy and reproducibility in drug screening, potency testing, and cellular response studies, critical for drug discovery and biologics.
We validate all bioanalytical methods to meet regulatory standards, ensuring consistent, reliable, and reproducible results for clinical and non-clinical studies.
Method development is not a cut-and-dry science, and rather requires some art that only comes with experience. Our scientists have 20+ years of experience in analytical development and method development for drugs, metabolites, and biomarkers. We provide comprehensive analytical development services that support the creation of precise and reliable methods for drug analysis. We offer tailored method development services that emphasize robust and straightforward method development and validation to ensure that multiple analysts and laboratories can reproduce the method independently under minimal supervision. For instance, we always start with a thorough sample clean up, and clear chromatographic separation as these two steps are critical for selectivity and reproducibility of LC-MS methods. Similarly, we focus on careful selection of mass spectrometric parameters essential for method sensitivity. Our veteran team’s fundamentals focused approach eases the progression of these methods from preclinical to clinical stage with minimal changes, leading to streamlined clinical sample analysis and accelerated data submission.
NorthEast BioLab is a drug testing laboratory that helps clients follow a scientific and known approach for various analysis. Our team believes in finding proper methods for superior outcomes and reliable drug testing. Expertise in techniques such as LC-MS/MS, HPLC, and ELISA offers us the capability of delivering solid, quantifiable results. We offer comprehensive method development services and analytical development services to ensure the selection of the most appropriate analytical methods for each project. Our analytical techniques definition ensures that we apply the most accurate and effective methodologies for each analysis. In addition to our experience and efficiency, we provide complete transparency to ensure the reliability of critical data and reduce the turnaround time of method development and validation.
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….
Drug development is an intricate process involving several phases. Analytical method development starts closer to the beginning of the drug development process at the discovery stage itself. Comprehensive method development services are crucial for ensuring the accuracy and reliability of analytical methods throughout this process. Method development for a New Chemical Entity (NCE) enables analysis in biological matrices for evaluation of drug pharmacology properties, such as bioavailability. Generally, a non-validated method is deployed at this stage of early drug discovery. As the drug progresses to IND enabling studies, however, further method development is required given the need for method robustness and full validation. Even more method development may be needed eventually, due to the change in matrices from animal species to human, as the drug moves farther into Phase I.
During clinical trials, method development helps mark a safe dose for human consumption. These trials are performed on human volunteers to ensure the stability, reliability, and effectiveness of the drug products and associated compounds. Usually, methods developed during the preclinical phase are modified and applied to human plasma samples at this stage. Further analytical method development is often required as more is discovered about the drug and its metabolism in this phase, necessitating the analysis for metabolites as well.
Several analytical methods are developed for testing the samples of different compounds in a variety of species. These methods eventually would be adapted to human samples. Adequate method development during the preclinical stage is essential for a straightforward transition from animal species to Clinical phase.
During drug discovery, scientists identify novel treatment targets, synthesize new molecules, screen these molecules in ‘in vivo’ and ‘in vitro’ assay, and study physicochemical aspects of the molecules. Multiple NCE are tested to determine the compound that may be best suited for the development of a drug, and each of these NCE requires prompt method development.
Answers to additional Bioanalytical Method Development questions popular among our potential clients.
Bioanalytical Method Development refers to the process of creating and validating analytical methods for detecting, quantifying, and identifying biological compounds such as drugs, metabolites, and biomarkers in various matrices like blood, plasma, and tissues.
Method Development Services involve specialized laboratories and experts developing and validating analytical methods tailored to the specific needs of pharmaceutical, biotechnology, and clinical research industries.
Analytical method development is a procedure for reliable detection of analytes of interest. High-grade method development ensures that the method is suitable for full validation and high-quality analysis of drugs, metabolites, and biomarkers in biological matrices.
Analytical Method Development is crucial in drug development as it ensures that methods are reliable, reproducible, and fit for purpose, which is essential for regulatory approvals and ensuring drug safety and efficacy.
Bioanalytical methods can be used to analyze a variety of samples, including blood, plasma, serum, urine, tissues, and other biological fluids.
Analytical Development Services encompass the development, optimization, and validation of analytical methods for the characterization and quality control of pharmaceutical products throughout their development lifecycle.
Common techniques include:
Analytical techniques refer to the methods and tools used to separate, identify, and quantify substances in a sample, providing data on its composition, structure, and quantity.
Method development involves creating and optimizing a method to analyze a sample, while method validation ensures that the developed method produces accurate, reliable, and consistent results within the required parameters.
Bioanalytical method development must comply with guidelines from regulatory bodies such as the FDA, EMA, and ICH, which include requirements for accuracy, precision, sensitivity, selectivity, and stability.
The development time can vary depending on the complexity of the method and the type of analyte but typically ranges from a few weeks to several months.
Bioanalytical method development specifically focuses on biological matrices and the quantification of biological molecules, whereas traditional analytical method development often deals with chemical compounds in non-biological matrices.
