Diagnostic-grade peptides manufactured under ISO 13485:2016 to support assay development, verification, and regulated testing workflows.
Bio-Synthesis supports diagnostic and testing teams at every stage — from routine in-house assays to regulated kit production. Our DX peptide program operates under an ISO 13485:2016 quality management system, with documentation and traceability designed for diagnostic applications.
Quick comparison of typical quality system features for RUO-grade vs Diagnostic (DX) peptides.
Note: Specific deliverables depend on peptide type, scale, and project requirements. The DX program is intended to support diagnostic development and testing workflows.
Release documentation aligned to your requested requirements.
Purity profile and chromatogram output (as applicable).
Identity verification report for the delivered peptide.
Batch records and traceability elements designed for DX workflows.
Diagnostic (DX) peptides are often used as assay reagents, controls, calibrators, and detection/quantification standards. Below are the most common peptide formats requested for diagnostic workflows under an ISO 13485:2016 quality system.
Defined sequences with controlled manufacturing, targeted purity, and lot-to-lot consistency to support assay validation and kit workflows.
Peptides conjugated to fluorophores for detection assays (e.g., binding studies, immunoassays, FRET formats). Common labels include FITC, TAMRA, Cy3/Cy5, and other dyes.
13C / 15N (and other stable isotope) labeled peptides used as internal standards and calibrators for LC–MS/MS quantification and biomarker workflows.
Biotin-tagged peptides for immobilization and capture formats (streptavidin systems), frequently used in diagnostic assay development.
Peptide-to-carrier or peptide-to-protein conjugates (application-dependent) to support immunoassay reagent formats and analytical workflows.
Audit-ready documentation, traceability, and controlled release deliverables aligned with diagnostic development and regulated production needs.
“Diagnostic-grade” commonly refers to peptides produced with enhanced traceability, controlled documentation, and quality system elements aligned to diagnostic development and regulated production needs (e.g., ISO 13485:2016).
Yes. DX projects frequently request fluorescent-labeled peptides for detection formats and stable isotope-labeled peptides for LC–MS/MS quantification workflows. Share your label and assay context and we’ll recommend an optimal approach.
Documentation is project-dependent, but may include a CoA, analytical outputs (HPLC/MS), lot identifiers, and traceability elements. If you have specific deliverables or audit requirements, we can align the release package accordingly.
Yes. For diagnostic workflows, lot-to-lot consistency is often critical. We can discuss specifications, testing expectations, and change control considerations to help support continuity across manufacturing lots.
Intended use depends on your final application and regulatory pathway. This page describes quality system and documentation support; please discuss your intended use and requirements with our team so we can align the appropriate grade and deliverables.
Share your peptide requirements, assay context, and documentation needs — we’ll recommend the right DX-grade path.
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