Assay Design & Development
Ensuring accurate and reproducible results.
Don’t settle for generic solutions. We design and develop customized assays specifically tailored to your product candidate and research objectives. Our science team’s extensive experience and collaborative approach ensures we can meet your specific requirements and develop assays efficiently, saving you valuable time and resources.
The goal is to ensure that the assay used to measure your product is accurate, precise and reliable. We follow the key steps recommended by regulatory (FDA, EMA, etc.) guidance, as well as instructions from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for any analytical method development and validation.
Our process
Feasibility assessment
During an initial feasibility assessment, a literature review is conducted to identify existing methods and establish a baseline for the method development process. This step involves reviewing scientific literature, regulatory guidance, and industry standards to determine the current state of the art and identify potential methods that may be suitable for the intended purpose. In silico analyses, antibody identification and target characterization may be carried out.
Assay optimization
The analytical method is optimized to ensure that it is sensitive, specific, and robust. This step involves evaluating various parameters, such as sample preparation or calibrator selection to optimize the method performance.
Assay validation
We follow ICH M10 guidelines on validation of bioanalytical methods to demonstrate that an analytical method is suitable for its intended use, and that it is capable of producing reliable and consistent results over time. The validation process involves a set of procedures and tests designed to evaluate the performance characteristics of the method, including:
Accuracy, Precision, Sensitivity, Linearity, Range, Limit of detection (LOD), Limit of quantification (LOQ), Robustness
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