When your research involves a novel target or a unique mechanism of action for which no standard assay exists, a skilled and collaborative development partner is essential. BioLegacy provides a comprehensive, end-to-end custom assay development service designed to tackle your most complex scientific challenges. We partner with you to design, build, optimize, and validate robust biochemical or cell-based assays from the ground up, leveraging our extensive in-house bioanalytical capabilities, from high-sensitivity immunoassays to flow cytometry and qPCR. Our rigorous, phase-appropriate validation process ensures you receive a fit-for-purpose, decision-driving tool that delivers the clear, reproducible data needed to advance your program.
BioLegacy’s custom assay development service begins with a deep, collaborative consultation where our PhD-level scientists work with you to understand your target’s unique biology and define the critical parameters for a successful assay. We conduct a thorough feasibility assessment, exploring different technology platforms and methodologies to architect a robust, scientifically-sound development plan that aligns with your specific research goals and regulatory needs.
Once a clear strategy is defined, our team systematically tests and refines all critical assay components and parameters — from reagent selection and concentration to incubation times and buffer conditions — to maximize sensitivity, specificity, and reproducibility. Our meticulous, data-driven optimization ensures the resulting method is robust and capable of generating the high-quality data your program demands.
BioLegacy conducts a rigorous, phase-appropriate validation to formally document that the assay performs as intended. We conduct validation studies according to the specific needs of your program, from qualified assays for exploratory research to full, GLP-compliant validation following ICH and FDA guidelines. Upon completion, we can deliver a comprehensive, fully documented method for a seamless technology transfer to your organization.
BioLegacy’s custom assay development ensures your assays are exactly fit for purpose.