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Assay Development & Optimization Services 

Accelerating Immunoassay Innovation from Concept to Commercialization

IMD provides comprehensive assay development and optimization services for research, diagnostic, and translational applications. Leveraging our extensive expertise in immunology, biomarker discovery, and analytical assay design, we help clients develop robust, sensitive, and reproducible testing solutions tailored to their specific needs—whether developing a novel biomarker assay, improving an existing platform, or transitioning a research assay toward commercialization.

Services Highlights

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ELISA Assay Development

Quantitative and qualitative biomarker detection across diverse applications

  • Development and optimization of enzyme-linked immunosorbent assays for cytokines, inflammatory markers, hormones, metabolic markers, and autoimmune/infectious disease biomarkers. Custom formats available including sandwich ELISA, competitive ELISA, and direct/indirect ELISA.

  • Our services include antibody screening, assay format design, reagent optimization, calibration curve establishment, sensitivity enhancement, and comprehensive performance evaluation.

Immunoturbidimetric Assay Development

High-throughput solutions for automated clinical chemistry analyzers

  • ​​Design and optimization of immunoturbidimetric assays suitable for automated clinical chemistry platforms. Applications include serum protein measurements, metabolic biomarkers, cardiovascular risk markers, inflammatory biomarkers, and clinical laboratory diagnostics.

  • We support antibody pair selection, latex particle conjugation optimization, buffer and reagent formulation, dynamic range optimization, precision and interference assessment, and analytical performance characterization.

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Fluorescent Lateral Flow Immunoassay (LFIA) Development

Rapid, high-sensitivity point-of-care testing solutions

  • ​​Development of fluorescent lateral flow assays for decentralized and point-of-care testing. Capabilities include test strip design and optimization, fluorescent label selection, antibody screening and characterization, conjugate pad optimization, signal enhancement strategies, assay sensitivity and specificity improvement, and reader compatibility assessment.

  • Suitable for rapid disease screening, infectious disease testing, point-of-care diagnostics, and quantitative biomarker measurement.

Feasibility Assessment & Assay Design

Strategic planning for assay success from day one

  • ​Comprehensive feasibility assessment including target biomarker evaluation, assay strategy consultation, technical risk analysis, and platform selection recommendations.

  • Antibody screening and pairing, assay format establishment, reagent formulation, and standard curve development to ensure your assay is built on a solid foundation.

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Optimization, Validation & Technology Transfer

Rigorous performance characterization and seamless commercialization support

  • ​​Optimization services including sensitivity improvement, specificity enhancement, dynamic range adjustment, matrix effect minimization, and reproducibility improvement.

  • Full analytical validation covering precision testing, accuracy assessment, limit of detection (LOD), limit of quantification (LOQ), linearity evaluation, and stability studies.

  • Technology transfer support including SOP preparation, manufacturing transfer support, QC strategy development, and regulatory-support documentation.

Our Development Workflow

1

Feasibility Assessment

  • Target evaluation,

  • strategy consultation,

  • risk analysis,

  • platform selection

​

2

3

Assay Design & Development

Optimization

  • Antibody screening,

  • format establishment,

  • reagent formulation,

  • standard curve development

  • Sensitivity/specificity enhancement,

  • dynamic range adjustment,

  • matrix effect minimization

4

Analytical Validation

5

Technology Transfer 

  • Precision,

  • accuracy,

  • LOD,

  • LOQ,

  • linearity,

  • stability studies

  • SOP preparation,

  • manufacturing support,

  • QC strategy,

  • regulatory documentation

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