Services offered

• Development of analytical methods for release
• Development and execution of characterization methods
• Extended characterization of reference material
• Comparability studies
• Purification and characterization of minor species (isomers, impurities,and degradants)
• In-process support during process development

Analytical Methods

Purity

• SDS-PAGE or capillary electrophoresis-SDS
• Isoelectric focusing (gel-based cIEF or imaged cIEF)
• Ion-exchange HPLC
• Size-exclusion HPLC
• Reversed-phase or hydrophobic interaction HPLC
• Host cell protein (HCP) ELISA
• Residual DNA
• Endotoxin

Primary Structure

• Western blot
• N-terminal amino acid sequencing
• Peptide mapping for detailed primary sequence analysis by LC-MS/MS
• Characterization of post-translational modifications by LC-MS/MS

Carbohydrate Analysis

• Monosaccharide composition analysis
• Sialic acid quantitation
• N-linked glycan profiling (fluorescent HPLC and CE-LIF
• Detailed glycan structural analysis by MALDI-TOF-MS and ESI-MS/MS

Functional Assays

• Cell-based bioassay
• Binding ELISA
• Surface plasmon resonance (BIAcore) and isothermal titration calorimetry (ITC)

Protein Mass

• High-resolution intact protein mass measurement by LC-ESI-MS
• Intact protein mass measurement by MALDI-TOF-MS

Conformational Analysis

• Circular dichroism (CD)
• Fluorescence
• Fourier transform infrared spectroscopy (FTIR)

Aggregation Analysis

• Dynamic light-scattering (DLS)
• Size-exclusion chromatography with multiangle laser light scattering (SEC-MALLS)
• HIAC liquid particle counting system

Physical Properties

• PH
• Osmolality
• Residual moisture by Karl Fischer

Process Residuals

• Process residual analysis by spectrophotometric assay
• HPLC, ELISA, or LC-MS/MS, including surfactants, methotrexate
• Host cell protein (HCP)
• Residual DNA (qPCR)
• Endotoxin