United Pharmaceuticals delivers comprehensive biomarker solutions designed to support informed decision-making from early discovery through late-stage clinical development. Our scientific teams develop and validate fit-for-purpose biomarker assays that align with study objectives, therapeutic modality, and regulatory expectations.
By integrating advanced analytical technologies with deep biological expertise, we enable accurate biomarker measurement that supports translational relevance, safety assessment, and efficacy evaluation across development stages.
Our team utilizes advanced ligand binding assay platforms to design customized biomarker assays tailored to the specific needs of each study. These platforms support multiple detection modes, including absorbance, luminescence, and fluorescence, allowing flexibility in assay design based on biomarker characteristics and sample constraints.
For studies requiring high throughput and multi-analyte detection, we apply multiplex biomarker technologies capable of simultaneously measuring a large number of analytes with high sensitivity and reproducibility. These approaches are particularly valuable for pathway analysis, disease profiling, and translational research.
In addition, we offer single-cell biomarker assessment using enzyme-linked immunospot assays and flow cytometry techniques, enabling detailed evaluation of cellular responses and immune-related biomarkers in both preclinical and clinical settings.
United Pharmaceuticals provides advanced biomarker quantification using liquid chromatography–mass spectrometry methodologies designed to deliver high-resolution and accurate mass measurements. Our laboratories are equipped to support complex biomarker analysis through optimized sample preparation workflows and sensitive detection strategies.
Liquid chromatography–mass spectrometry-based biomarker analysis is applied across discovery, nonclinical, and regulated clinical studies, supporting both exploratory and validated endpoints. These methods are particularly effective for protein and peptide biomarkers where specificity and quantitative accuracy are critical.
Regulatory agencies increasingly recognize the value of biomarkers in accelerating drug development and improving translational outcomes. Regulatory authorities emphasize biomarkers for their role in linking nonclinical findings to clinical outcomes, particularly within translational medicine frameworks.
While regulatory programs exist to support biomarker qualification, successful implementation requires early planning. United Pharmaceuticals encourages the incorporation of biomarker endpoints during preclinical study design to support later-stage efficacy and safety assessments. Early identification of relevant biomarkers helps establish a mechanistic understanding and supports data continuity as programs advance into clinical development.
Biomarker bioanalysis often presents greater complexity than drug concentration measurement, particularly when biomarkers are endogenous proteins with variable baseline levels. To address these challenges, United Pharmaceuticals designs assays that are fit for purpose, scientifically robust, and aligned with study intent.
Our team collaborates early in development to design integrated preclinical-to-clinical biomarker strategies. This collaborative approach enhances data interpretability, improves translational relevance, and supports confident decision-making throughout the development process.