Services

Custom Calibrator & QC Material Manufacturing

Inquiry

When off-the-shelf materials cannot meet your specifications, we develop and manufacture tailor-made calibrators, controls, and performance verification panels to your exact requirements — from early assay development through commercial lot release. Each project is built around your defined analytes, matrix, concentration range, and format, with documented traceability and stability data.

Every diagnostic assay needs calibrators and controls that are fit for its specific design, yet standard catalog products often fall short for novel biomarkers, special matrices, or non-standard measurement ranges. Purpose-built materials close that gap: they accelerate assay development, strengthen regulatory submissions, and reduce time to market. By offering flexible, small-batch-to-bulk manufacturing, we help diagnostic developers and laboratories turn a validated method into a reliable, reproducible product without building dedicated production lines of their own.

What We Manufacture

Working calibrators – for routine and specialty assay systems.
Enterprise reference panels – internal reference materials for manufacturers.
Linearity panels – for evaluating reportable range and linear performance.
Sensitivity (limit-of-detection) panels – for low-concentration verification.
Interference panels – for assessing cross-reactivity and sample-effect bias.
Inhibition panels – for recovery and matrix-effect evaluation.
Seroconversion panels – for diagnostic sensitivity across disease stages.

Service Advantages

Attribute	Description
Traceability	Assigned values traceable to international / national reference materials or reference methods
Materials	Human-source matrices with controlled background composition
Coverage	Multiple disease areas and analyte classes
Platform fit	Suitable for multiple detection platforms
Support	Dedicated technical and regulatory support throughout the project
Quality system	Manufactured under a documented quality management system with COA and stability documentation

Customization Workflow

Define target analytes, matrix, and concentration range.
Confirm format (lyophilized or liquid) and fill volume.
Produce a pilot batch with COA and stability data for evaluation.
Scale up to commercial volumes under a documented quality management system with consistent lot-to-lot quality.

Applications

These services support IVD manufacturers (research and development, regulatory registration, incoming and release testing), clinical laboratories (method validation and external quality assessment preparation), and research organizations working with novel biomarkers or non-standard matrices.

The service is for research only, not for clinical use.