Peptides for diagnostics, imaging and medical devices
Highly controlled peptides for immunoassays, biosensors, calibration curves and device coatings—where lot-to-lot consistency, label integrity and low host-interference matter more than gram-scale bulk.
>95–98%
purity bands
Biotin / dye
site-specific labels
mg–g
lot sizes
ISO
13485-ready docs (program)
Identity
LC-MS every lot
Diagnostics and device use cases
Capture and detection peptides for ELISA, peptide antigens for autoantibody panels, calibration standards for mass-spec quantitation and modified sequences for lateral flow and biosensor surfaces.
Device programs may require fixed manufacturing records, change notification and multi-year supply agreements even when individual lots are small.
Label and modification selection
| Assay format | Typical label | Analytical focus |
|---|---|---|
| ELISA / ECL | Biotin on Lys; digoxigenin | Purity at 214 nm; biotin content (indicative) |
| Fluorescence intensity | FAM, TAMRA, Cy5 | Dye ratio; photobleaching stress optional |
| FRET pair | Donor + quencher same backbone | Spectral match; confirm both modifications |
| Surface plasmon resonance | N-terminal thiol or biotin | Minimal hydrophobic aggregates |
| Mass spec quant internal standard | Unlabeled high purity | Isotopic label quoted separately |
Figures are indicative industry-typical values. Lot- and project-specific data appear on the quotation and certificate of analysis.
Purity and impurity expectations
RP-HPLC purity
>95% or >98%
Deletion sequences drive assay drift
LC-MS
Within Δ mass tolerance
Sub-ppm for high MW conjugates on HRMS
TFA / acetate
Reported
Interference in some electrochemical detectors
Endotoxin
Optional LAL
In vitro diagnostic vs invasive device paths
Adsorption control
Low carryover packaging
Glass vials for hydrophobic peptides
Figures are indicative industry-typical values. Lot- and project-specific data appear on the quotation and certificate of analysis.
Material qualification flow
Assay requirement brief
Label position, buffer compatibility, working concentration range.
Synthesis under locked method
Same route for repeat lots; change control for device filings.
Enhanced QC
Tight purity, identity and optional activity-binding confirmation by sponsor.
Stability monitoring
Accelerated data for kit shelf life when peptide is the limiting reagent.
Periodic requalification
Bridge lots when scale or resin supplier changes.
Documentation for IVD / device
- COA with full sequence and modification map
- Batch traceability and revision-controlled specification
- Stability summary where contract requires
- TSE/BSE and materials-of-origin statements (indicative templates)
- Change notification agreement for regulated programs
Frequently asked questions
Mass quantitation standards often use >98% with documented impurities. Fit-for-purpose purity is confirmed with the assay owner.
Related
Peptide Modifications
Terminal caps, cyclization, stapling, PTMs, fluorescent and affinity tags, PEG/lipid appendages and unnatural backbones—installed during SPPS or in solution after the chain is built. Each class changes synthesis time, purification and how the product should be specified on the COA.
View detailsCustom Peptide Synthesis
Solid-phase and solution synthesis of linear and modified peptides for discovery, assay development and lead optimization. Scale, purity tier and QC depth are matched to how the material will be used—not every program needs the same finishing step.
View detailsCosmetic Peptides
Signal peptides, carrier peptides and synthetic neuropeptide mimics for skin and hair care, supplied at cosmetic raw material purity with INCI-aligned naming and documentation suitable for PIF and safety assessments—not pharmaceutical release unless separately contracted.
View detailsGMP Peptide API
GMP-manufactured peptide drug substance for clinical trials and commercial demand under a quality system aligned to ICH and regional GMP expectations. Scope is drug substance—synthesis, purification, isolation, release and stability—not discovery-grade custom work.
View detailsReady to specify this for your program?
Share sequence, scale and documentation needs. We reply with indicative specs and a project-specific quotation.