Product Quality
The cornerstone of any product development and manufacturing effort is the analytical characterization of the product and testing of all raw materials, bulk solutions, in-process materials, and finished product.
Our well-designed analytical programs satisfy regulatory requirements to assure the success of the clinical program. Our dedicated analytical scientists customize phase-appropriate analytical programs to the specific needs of your unique molecule, delivering a comprehensive understanding and characterization of the molecule for each stage of development and commercialization.
Analytical Capabilities
Our on-site laboratories are equipped with sophisticated analytical instrumentation, enabling scientists to employ a full range of methodologies and techniques to characterize your product and develop test methods that will validate your product’s integrity throughout its life cycle.
Primary Structure Analysis
- Peptide mapping via UV-HPLC or LC/MS/MS (QTOF, Ion Trap)
Biophysical Characterization
- Multi-angle light scattering (MALS)
- Fourier-Transform infrared spectroscopy (FTIR)
- Scanning calorimetry (DSC)
- Dynamic light scattering (DLS)
- UV/VIS spectroscopy
- Electrophoretic mobility (Zeta-potential)
Glycan Analysis
- Monosaccharide composition
- Oligosaccharide mapping
- Sialic acid quantitation
HPLC
- Size-exclusion chromatography
- Ion-exchange chromatography
- Affinity-based chromatography
- Reversed-phase chromatography
Capillary and Conventional Gel Electrophoresis
- Capillary isoelectric focusing (cIEF)
- SDS-PAGE and AGE
- Western blot
- Dot blot
Process Residuals
- ELISA
- qPCR
- HPLC (antibiotics, IPTG, surfactants, etc.)
Potency Assays
- Enzymatic activity assays
Particulate Analysis, Including Sub-10 Micron Particle Characterization
- Asymmetric-flow field flow fractionation (A4F)
- Sub-10 micron particle characterization
Mass Spectrometry (QTOF, ION TRAP)
- Intact mass mapping
- Disulfide mapping
- PEGylation site identification
- Peptide mapping with LC/MS or LC/MS/MS
- Identify post translational modifications (oxidation, deamidation)
- Glycan characterization & linkage-site identification