- Amino Acid Composition Analysis (AAA)
Determination of amino acid composition of a protein. Used for confirmation of primary structure.
- N- and C-terminal Sequencing
Determination of amino acid sequence from the N- and C-terminus of protein using Edman sequencing and/or MALDI-ISD. Used as a confirmation of primary structure or de novo sequencing.
- 1D/2D SDS-PAGE
Detection of mono- and multimeric forms of protein and impurities.
- (Capillary) Isoelectric Focusing (IEF + cIEF)
Determination of the isoelectric point (pl) of a protein and assessment of isoform distribution and impurity profiling.
- Western Blot
Identification of proteins by their immunologic reaction with antibodies of known specificity (from 1D and 2D PAGE gels).
- SEC-HPLC-UV and SEC-HPLC-MALS
Separation of protein based on size. Determination of degree of aggregation.
- RP and IEX-HPLC
Identity, content and impurity determination. Detection of oxidation and deamidation products.
- Peptide Mapping (by LC-MS) and MS/MS (de novo) Protein Sequencing
Used to confirm identity/primary structure. Enzymatic digestion of protein followed by mass spectrometry.
- Monosaccharide Composition
Quantification of neutral amino sugars: glucosamine, galactosamine, mannose, galactose and fucose.
Carbohydrate Linkage Analysis Determination of monosaccharide linkage variants as part of a glycan structure analysis.
- Sialic Acid Determination
Quantitation of acidic sugars NANA (Neu5Ac) and NGNA (Neu5Gc).
- Oligosaccharide Profiling
N-linked and O-linked oligosaccharide profiling including analysis of sialylated and desialylated carbohydrate structures by NP-HPLC (HILIC), HPAEC-PAD and mass spectrometry.
- ELISA/ILA
Detection and quantitation of residual proteins including BSA, Protein A and host cell proteins. Proprietary HCP assays for CHO and E. coli; also useful in bioassays and protein characterization.
- Extinction Coefficient
Determination of extinction coefficient and content of protein by UV and Amino Acid Analysis.
- Determination of Protein Content
Routine determination by UV or other methods.
- Glycosylation/Sulfation/Phosphorylation Site Identification
Mass spectrometry analysis to determine the site of post-translational modifications.
- Disulfide Bridge Analysis
Cystine linkage sites are identified (de novo assessment and/or confirmation).
- Oxidation and Deamidation Analysis
Mass spectrometry is used for detailed characterization of extent and site of modification.
- Presentation-Specific Testing
Physicochemical testing as required for the product type (e.g., osmolality, sub-visible particulates, moisture content).
- Capillary (Zone or SDS) Electrophoresis
Used for the characterization and separation of protein mixtures based on mass or charge.
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