Assay Development & Manufacturing

Successful assay development requires more than a single reagent. Specimen selection, matrix behavior, calibration strategy, reagent stability, assay format, analytical performance, and manufacturability all influence the path from concept to a reproducible diagnostic product.

Monobind supports assay developers with biological materials, established diagnostic components, development-format tools, proprietary enabling technologies, research capabilities, and scalable manufacturing resources.

Samples & Biological Matrices

Start development with biological materials selected around the analyte, concentration range, specimen type, and intended analytical application.

Characterized Patient Samples & Custom Panels

Individual human specimens selected around characterized analyte concentrations, target ranges, or defined study requirements for feasibility, sensitivity, cutoff, optimization, and validation work.

Matrices for Calibrators & Controls

Human serum, plasma, urine, stripped, low-analyte, specialty, and custom matrices supplied as base material or configured to defined analyte requirements.

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Development & Internal QC Biomaterials

Ready-to-use aliquots of serum, urine, albumin, gamma globulin, and specialty matrices for early-stage development, evaluation, and laboratory studies.

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Modified Assay Formats

Explore assay adaptations developed for alternate specimen types, specialized workflows, veterinary applications, and flexible testing formats beyond conventional laboratory configurations.

Direct-to-Patient Solutions

Adapted assay formats supporting alternate specimen collection and laboratory-developed testing workflows, including whole-blood applications for remote and patient-directed collection models.

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Monotest Solutions

Flexible strip-based ELISA and CLIA assay formats designed around simplified calibration and control configurations for streamlined laboratory workflows and future instrument integration.

Technology in developmentExplore Monotest solutions

Animal-Adapted Assays

Veterinary and animal-health assay formats adapted for species-specific applications, including hormone, reproductive, thyroid, and other diagnostic testing needs.

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Assay Development Tools & Enabling Technologies

Use development-format kits, consumables, reagents, controls, and enabling technologies to support assay prototyping, optimization, sample handling, and performance evaluation.

Stabilizers & Enabling Technologies

Stabilization and enabling technologies designed to support reagent performance, formulation stability, workflow efficiency, and assay development.

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In-House Assay Development Kits

Development-format assay kits and component systems for feasibility, prototyping, assay optimization, customization, and internal method development.

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Collection Cards

Whole-blood collection cards for sample collection, storage, transport, screening, diagnostic development, and research workflows.

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Assay Plates

Plates and assay-development consumables for prototyping, immunoassay development, testing workflows, and laboratory method optimization.

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Diluents & Controls

Sample diluents, zero-calibrator matrices, and QSure® controls supporting sample preparation, assay verification, optimization, and reproducible analytical performance.

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Development & Manufacturing Services

Extend internal development capabilities with formulation, research, technical support, and scalable diagnostic manufacturing.

Custom Formulation & OEM Development Support

Custom formulation and development support for assay components, matrices, reagents, controls, calibrators, and OEM diagnostic applications.

Contract Research Services

Technical and laboratory support for feasibility, assay development, optimization, analytical studies, material evaluation, and defined development programs.

Contract Manufacturing Services

Scalable manufacturing capabilities supporting diagnostic products and components from development quantities through recurring commercial production.

Support Across the Assay Development Pathway

Monobind capabilities can be integrated at individual stages of development or combined to support a broader development program.

Feasibility
Prototype
Optimization
Validation
Scale-up
Manufacturing

Explore Assay Development Resources

Browse development materials, biological matrices, tools, and related scientific resources.

Tell Us About Your Assay Development Project

Tell us what you are developing and where you are in the process. Our team can help identify relevant specimens, matrices, reagents, tools, technologies, or development services.

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