Peptides require advanced characterization and release testing. Solvias specializes in physicochemical analysis, biosafety evaluations, and product release testing within a cGMP framework. Our comprehensive structural analysis helps pinpoint potential issues with critical quality attributes (CQA), ensuring a seamless progression from early-phase development to commercial readiness.
Specific capabilities for peptide characterization include:
Primary Structure
- Amino acid analysis (including peptide content)
- Sequencing by tandem mass spectrometry (MS/MS)
- Identity by MS
- Impurity by MS (Capillary isoelectric focusing, pI, identity)
Higher Order Structure
- Circular dichroism (CD) 2nd structure
- Differential scanning calorimetry (DSC), Fourier-transform infrared spectroscopy (FT-IR)
- Nuclear magnetic resonance spectroscopy (NMR)
Aggregation & Heterogeneity
- Size exclusion chromatography (SEC)/Multi-angle light scattering (MALS), Sedimentation velocity analytical ultracentrifugation (SV-AUC)
- Light obscuration, Micro-flow imaging (MFI), Dynamic light scattering (DLS), Asymmetric flow field flow fractionation (AF4)
- Intact mass (Reversed-phase mass spectrometry – RP-MS)
Biosafety & Functionality
- Bio-identity by enzyme-linked immunosorbent assay (ELISA)/Surface plasmon resonance (SPR)
- Endotoxin testing
- Bioburden (e.g. total viable count)
- Sterility testing
Physicochemical Properties
- Color, appearance, pH, turbidity, melting point
- Solubility
- Optical rotation
- Crystallinity
- Polymorphism
- Salt screen enabling stable form
Purity & Content
- Quantification/isomer profiling by liquid chromatography–mass spectrometry (LC–MS)(/MS)
- LC-UV-MS, peak purity, Capillary zone electrophoresis ultraviolet–mass spectrometry (CZE-UV/MS)
- Assay, purity, related substances, ID, CU by HPLC, counter ion by ion chromatography, titration (water, ion content)
- Residue on ignition (sulfated ash)
