Whether for assessing biomarkers or testing novel drug products, understanding the protein concentration in biological matrices is the basic requirement in clinical and biomedical research. The Meso Scale Discovery platform is a robust technique to analyze multiple analytes in various biological samples simultaneously. Meso Scale Discovery (MSD) assays require relatively low sample volumes and are highly consistent between runs. These characteristics make MSD assay the ideal platform for assessing molecules in complex matrices.
MSD has a plethora of assay options available for each drug discovery pathway. MSD’s introduction to drug discovery and development has been a boon for sponsors and drug developers. MSD develops and validates custom panels with precision for all drug development needs, such as MSD immunogenicity assays and comprehensive biomarker testing. However, a lot depends on adequate assay development and validation. Let us dive into the need and approaches for MSD assay development and validation.
Streamlining MSD assay validation
Today clinical and biomedical research increasingly depends on reliable tests for making developmental decisions. However, developing a bioanalytical assay is a challenging task. MSD has streamlined the entire assay development and validation process to suit all drug development applications. They have successfully partnered with companies and institutions to develop MSD assays for a broad range of proteins, phosphoproteins, and drug interactions. Hence, depending on individual needs, MSD develops and validates assays for basic as well as translational research.
MSD has a personalized service to notify clients regarding project status through regular updates, interactive discussion, and decision-making guidance.. To further streamline a drug development project, they have divided the assay development process into three stages; feasibility, development and verification, and assay validation. The initial process begins with developing assays through a proof-of-concept approach and selecting the primary antibodies and assay performance criteria. This initial process is followed by delivering a fully developed assay and testing different parameters such as dynamic range, limits of detection, and sample evaluation. Finally, the developed method is validated by testing further validation variables such as precision, accuracy, reproducibility, etc.
All MSD assays follow the Clinical Laboratory Standards for validation parameters. Besides, as mentioned before, assay validation is conducted through a Fit-for-purpose approach for development and validation. MSD ensures a robust assay validation by functionally characterizing the antibodies, calibrators, and other components between different assay lots. This characterization includes bridging the control and kit components and plate coating uniformity for consistency and reproducibility. Moreover, matrix-specific control samples are tested to ensure accuracy, sensitivity, and precision in MSD kits.
The validation factors include sensitivity, calibration curve, dynamic range, robustness, specificity, and inter- intra- assay precision and accuracy. Besides such detailed assay validation, MSD assays are verified through multi-runs using 3-9 plates per day for testing each lot before release.
The road ahead for MSD assays
Due to its ability to analyze multiple compounds and save valuable biological samples, MSD assays are increasingly becoming a core component of preclinical and clinical research. However, sponsors must consider a robust MSD assay validation to ensure reliable safety and efficacy data generation.