Orthogonal analytics for peptide drugs
Tell us the molecule, development stage and regulatory target. We propose an analytical plan within 2 business days.
Platform methods are adapted to your peptide and formulation; key parameters are confirmed before sample commitment.
SV-AUC, CD, icIEF and reporter bioassay runs are performed on the same sample set under controlled, documented conditions.
Cross-method interpretation aligned to ICH Q6B / Q5E, with raw data and method descriptions.
Cell-based luciferase reporter gene bioassay
Stable cell lines co-expressing GLP-1R (or GIPR / GCGR) and a CRE-luciferase reporter: agonist binding triggers the Gs → cAMP → CRE cascade driving luciferase expression, and luminescence is read as the pathway-activation signal.
Dose–response curves and model parameters support comparison with an agreed reference. Relative potency is reported when the comparison is suitable.
For dual and triple agonists such as tirzepatide, retatrutide and mazdutide, parallel assays on GLP-1R, GIPR and GCGR reporter lines characterize each receptor pathway and quantify activity bias relative to the reference product.
Documented for regulatory scrutiny
Studies are executed under controlled conditions with GMP-like documentation practices. Reports map each result to ICH Q6B characterization and ICH Q5E comparability expectations, and to compendial methods in USP, Ph. Eur. and ChP where applicable.
Which question does each method answer?
| Parameter | SV-AUC | CD | cIEF | Notes |
|---|---|---|---|---|
| Aggregation & oligomers | c(s) distribution, % monomer/aggregates | — | — | AUC is matrix-free; orthogonal to SEC |
| Molecular weight | Sedimentation-based estimate | — | — | Confirms identity & oligomer stoichiometry |
| Secondary structure | — | α-helix / β-sheet (far-UV) | — | Fingerprint vs. reference product |
| Tertiary structure | — | Near-UV aromatic profile | — | Sensitive to folding changes |
| Thermal stability | — | Tm from thermal melt | — | Formulation ranking |
| Charge heterogeneity | — | — | pI + acidic/basic variant % | Deamidation monitoring |
| Identity | s20,w | Spectral fingerprint | pI | Three independent identity criteria |
| Self-association | Concentration-dependent s | Indirect | — | Key for lipidated peptides |
| Sample per study | Low | Low | Low | One sample set for all four |
All four methods are run on the same sample set and reported together — no method substitutes for another; each answers a different physical question.
Sedimentation, optical spectroscopy, charge-based separation and cell-based bioactivity rest on independent principles — regulatory-grade triangulation.
AUC measures in solution without columns or membranes; CD and cIEF run in your actual formulation buffer.
A single, small sample set feeds all four methods — critical in early development when material is scarce.
Discuss the method, reference standard, sample conditions and documentation with our team.