Peptides
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:
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customised solutions in terms of analytical protocols and innovative technologies throughout non-clinical and clinical development
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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
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regulatory, scientific and technical excellence with a problem-solving approach
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compliance with all applicable EMA, FDA and ICH regulations
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GMP, GLP, GCLP/GCP environment
Your one-stop shop for analytical services
Outsource your analytical needs on one site for more efficiency including:
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Analytical development
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Validation of analytical methods as per ICH guidelines
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Potency assays
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Characterisation
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By Mass Spectrometry
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Peptide mapping
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Aggregation study
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Stability studies
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Batch testing
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Bioanalytical services
GENERAL QUALITY
| Appearance | |
| 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 | |
| Solubility |
IDENTITY
| 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 |
QUANTITY
| Assay | UV / (U)HPLC (UV, RI, fluorescence, MS) |
| Determination of extinction coefficient | UV + ICP-MS/MS (isotope dilution) |
PURITY & INTEGRITY
| 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) |
POTENCY
| 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 |
PROCESS-RELATED IMPURITIES
| 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 |
PACKAGING
| 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> |
PHARMACOKINETICS & TOXICOKINETICS / BIOMARKERS / IMMUNOGENICITY
| Drug / Metabolites | ELISA / Electrochemiluminescence (MSD) / Luminex / UPLC (MS/MS) / ICP (OES, MS) / ESI-QTOF |
| Biomarkers | ELISA / Electrochemiluminescence (MSD) / Luminex / UPLC (MS/MS) |
| Vehicles / Buffers | ELISA / Electrochemiluminescence (MSD) / Luminex / (U)HPLC (UV, RI, DAD, FLUO, ELSD, CAD, MS) / ICP (OES, MS) |
| Immunogenicity | ELISA / Electrochemiluminescence (MSD) / Luminex / Cell-based assays (neutralisation) / Biacore |
