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.

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