We set-up and validate robust analytical methods for quantitation of your drugs and biomarkers, considering distinct assay factors such as analytical specificity, selectivity, and sensitivity. Analytical specificity represents the assay’s ability to measure a specific analyte within a sample with matrix and ingredients. Analytical selectivity defines the capability to separate and detect the analyte within a complex matrix without any interference from other components. Analytical sensitivity asserts the smallest amount of an analyte that can be measured in an assay correctly.
Likewise, our team utilizes a suitable calibration curve to determine the concentration of your analyte in an unknown sample. This analysis requires a comparison of unknown samples to a set of standard samples of known concentration and quality controls processed within the same matrix. Sometimes, these assays become very challenging – especially if the unknown sample is endogenous, environmental, or biologically complex. That said, our veteran scientists at NorthEast BioLab are quite familiar with these method and analysis hurdles and capably resolve such issues if/when they arise.
Our team of scientists works diligently to base our research and studies as per the boundaries outlined within your analytical assay. We tenaciously pursue precision and accuracy for our methods to ensure reliable and reproducible results. We rely extensively on the triple quadrupole mass spectrometry and ligand binding detection techniques as they usually deliver superior sample analysis results.
Significance of Calibration Curve in Analytical Assay Sensitivity and Robustness
At NorthEast BioLab, we understand the overall value and proven significance of the calibration curve towards analytical assay sensitivity and robustness. For example, multiple studies have shown that the linearity of a calibration curve plays an instrumental role in the overall ruggedness of the bioanalytical method. Thus, this linear curve lays the foundation for minimal error in the calibration model. Ideally, the calibration model reflects that all calculated measurements are accurate, precise, and reproducible for analytes of interest in test samples from biological and chemical matrices.
In general, calibration curves are used in various scientific fields – including pharmaceutical chemistry and biochemistry. We use these curves with bioanalytical data to measure the analyte concentration in a wide variety of samples. For example, we regularly assess the levels of active pharmaceutical ingredients and their metabolites in biological matrices using calibration curves for preclinical toxicology and clinical safety determinations. Furthermore, we follow FDA and ICH guidelines regarding analytical method validation and sample analysis, including the direction on calibration curves. Our compliance with these international guidelines benefits clients as they receive and further report consistent data for drug approval.
Defining Upper and Lower Limit of Quantification (ULOQ & LLOQ)
We must understand the test analyte, system, and endpoint needs of an assay to select its upper and lower limits of quantification appropriately. Ideally, the limits of quantitation should cover the anticipated range of analyte concentration in the samples from any given study completely. This Calibration range is usually determined based on the performance requirements outlined by both our scientists and the clients along with any predefined acceptance guidelines.
For bioanalytical assays:
LLOQ: The lower limit of quantitation reflects the lowest standard within the calibration curve. The detection response for the analyte sampled must be at least five times over the targeted blank.
- Detection Response: Reproducible, discrete and identifiable.
- Precision: Within 20% of CV
- Accuracy: Within 20% of nominal concentration
ULOQ: The upper limit of quantitation is the highest standard within the calibration curve.
- Detection Response: Reproducible
- Precision: Within 15% of CV
- Accuracy: Within 15% of nominal concentration
It is essential to avoid any extrapolation above the ULOQ or below the LLOQ when working with unknown samples. Our team at NorthEast BioLab pays close attention to ensure the calibration range remains balanced and accurate for our client projects.
Why Choose NorthEast BioLab to meet the Specificity, Selectivity, Sensitivity, and Calibration needs of your Analytical Assay
NorthEast BioLab’s primary focus is the success of your drug development program. Over the past few years, we have expanded our services to include all aspects of integrated bioanalytical research and testing. Our clients lean on us to provide them with quality testing, operational integrity, and expertise with each project that we accept. Thus, quantitation methods developed at our facility are thoroughly tested to meet the specificity, selectivity, sensitivity, and calibration requirements of our clients and various regulatory agencies.
Another reason why our clients choose us over the competition is the knowledge we have acquired about the industry and the regulatory environment in general. We leverage this scientific expertise to meet the needs of our clients and exceed their expectations.
You can rely on the 100% process transparency offered to all our clients and trust our team to reflect the same level of passion, integrity, and teamwork that you expect within your own company. Our client-centric approach to completing projects, conducting tests, and advancing drug development is what sets us apart. It is also the reason why our clients do not hesitate to call us whenever they need further assistance.