Therapeutic peptides are at the crossroads of small molecules and proteins, requiring specific analytical packages depending on whether they are of recombinant or synthetic origin.

In both cases, Quality Assistance provides customised solutions in terms of analytical protocols and innovative technologies to help you move your peptide through nonclinical and clinical development towards registration.

Your analytical partner providing:

  • customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development

  • a full range of equipment in Chromatography, Mass Spectrometry, Biochemistry, Cell Biology, Pharmaceutical Technologies and Microbiology, to meet all the challenges of developing and validating methods

  • regulatory, scientific and technical excellence with a problem-solving approach

  • compliance with all applicable EMA, FDA and ICH regulations

  • GMP, GLP, GCLP/GCP environment

Your one-stop shop for analytical services

Outsource your analytical needs on one site for more efficiency including:

  • Analytical development

  • Validation of analytical methods as per ICH guidelines

  • Potency assays

  • Characterisation 

    • By Mass Spectrometry

    • Peptide mapping

    • Aggregation study

  • Stability studies

  • Batch testing

  • Bioanalytical services

pH / Osmolarity (if liquid)  
Isoelectric point (ic)IEF
Particulate matter Optical microscopy / Light obscuration / Imaging Particle Analysis
Particle size (formulation) DLS
Water content / residual moisture (if lyophilised) KF titration (volumetric, coulometric, oven)
Properties after reconstitution  
Intact peptide (U)HPLC (UV, RI, fluorescence, MS)
Molecular weight ESI-MS / MALDI-TOF
Peptide mapping and / or sequencing UPLC (UV, MSE)
Immunological identification ELISA / ECL (MSD) / Western blotting
Assay UV / (U)HPLC (UV, RI, fluorescence, MS)
Determination of extinction coefficient UV + ICP-MS/MS (isotope dilution)
Purity profile IEX / RP-(U)HPLC / (ic)IEF
High order structure Circular Dichroïsm (CD) / FT-IR
Mass distribution profile ESI-MS / MALDI-TOF
Chemical modifications (U)HPLC (UV, MS) / CE(UV, LIF)
Degradation patterns (Oxidation, deamidation, truncation) IEX / RP-(U)HPLC (UV, MS) / CE (iclEF, cGE)
Aggregation and particle size distribution AF4 & SEC-(U)HPLC (UV/RI/MALS) / DLS / Imaging Particle Analysis
Disulfide bridges Peptide mapping (UPLC-UV/MS) / SDS-PAGE / cGE
Free thiols Fluorescence (NPM), UV (EIIman)
Enantiomeric purity (U)HPLC-UV / GC-MS / CE
Counter-ion content (Mass balance) (U)HPLC (UV, MS) / ICP (OES, MS)
Immunoassays ELISA / ECL (MSD) / Biacore / FACS / Octet (BLI)
Cell-based assays (Cytotoxicity / Proliferative / Cell death / Cell migration / Cell receptor binding and activation / Reporter gene assays / etc.) Different read outs
Microbiology Bioburden / Sterility (filtration, direct inoculation)
Endotoxins LAL (kinetic, end point), Monocyte Activation Test
Elemental Impurities ICP-MS
Residual solvents (synthetic peptides) HS-GC (FID, MS)
Residual proteins (recombinant peptides) ELISA / ECL(MSD) / Luminex / UPLC-MS / Western blot / 2D-DIGE
Residual DNA (recombinant peptides) QPCR / Picogreen
Leachables  GC (FID, ECD, MS) / ICP (OES, MS) / (U)HPLC (UV, ELSD, CAD, MS)
Container Closure System Integrity Bubbling / Dye ingress (methylene blue, fluorescence) / Microbial ingress
Cytotoxicity / Biological reactivity Cell-based assays / USP <87>
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