While our analytical development services are part of a comprehensive development and manufacturing program, they can also be offered as stand-alone services. In the past we have developed analytical methods for a wide range of proteins, including monoclonal antibodies and Fc fusions, enzymes, growth factors, complex glycoproteins, and novel recombinant constructs.
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
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
- N-linked glycan profiling (fluorescent HPLC detection)
- N + O-linked glycan profiling (fluorescent HPLC detection)
- Sialic acid quantitation
- Monosaccharide quantitation
- Detailed glycan structural analysis by MALDI-TOF-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
- 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
- Methotrexate and antibiotics by LC-MS/MS
- Other custom assay development available